Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00809354
Collaborator
(none)
2,720
333
5
23
8.2
0.4
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Study Design
Study Type:
Interventional
Actual Enrollment
:
2720 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Actual Study Start Date
:
Feb 12, 2009
Actual Primary Completion Date
:
Oct 28, 2010
Actual Study Completion Date
:
Jan 12, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: IV Placebo + NSAID Oral NSAID |
Drug: NSAID
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
|
| Experimental: Tanezumab 5 mg IV tanezumab 5 mg every 8 weeks (through Week 48) |
Biological: tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
|
| Experimental: Tanezumab 10 mg IV tanezumab 10 mg every 8 weeks (through Week 48) |
Biological: tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
|
| Experimental: Tanezumab 5 mg + NSAID IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks |
Biological: tanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48)
Drug: NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
|
| Experimental: Tanezumab 10 mg + NSAID IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks |
Biological: tanezumab
IV tanezumab 10 mg every 8 weeks (through Week 48)
Drug: NSAID
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 [Baseline, Week 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 [Baseline, Week 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 [Baseline, Week 16]
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Secondary Outcome Measures
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, and 24]
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
- Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
- Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) [Weeks 2, 4, 8, 12, 16, and 24]
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
- Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
- Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF [Baseline, Weeks 2, 4, 8, 12, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
- Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
- Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
- Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) [Baseline, Week 16]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
- Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) [Weeks 2, 4, 8, 12, 16, and 24]
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
- Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) [Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 2, 4, 8, 12, 16, and 24]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Weeks 12 and 24]
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
- Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 12, 24, 40, and 56]
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
- Number of Participants Who Had Discontinued Study Due to Lack of Efficacy [Baseline up to Week 56]
- Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 56]
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
- Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) [Baseline, Week 24]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) [Baseline, Week 24 and 56]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) [Baseline, Week 24]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) [Baseline, Weeks 24 and 56]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF [Baseline, Week 24]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF [Baseline, Weeks 24 and 56]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) [Baseline, Week 24]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) [Baseline, Weeks 24, and 56]
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
- Percentage of Participants Who Used Rescue Medication: Observed Data [Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
- Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) [Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
- Amount of Rescue Medication Used [Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.
- Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 [Baseline, Week 56]
- Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 [Baseline, Week 56]
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 64]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
- Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56]
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
- Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) [Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56]
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
- Plasma Trough (Pre-dose) Concentration of Tanezumab [Predose on Day 1, Weeks 16, 24, 40, and 56]
- Number of Participants With Intravenous (IV) Doses of Study Medication [Baseline up to Week 48]
Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.
Other Outcome Measures
- Number of Participants With Anti-Drug Antibody (ADA) Response [Baseline, Weeks 16, 40, 24, and 56]
Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive.
- Number of Participants With Positive Urine or Serum Pregnancy Test [Baseline up to Week 56]
Female participants, who reported positive in urine or serum pregnancy test were reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
-
Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
-
Pain level and function levels as required by the protocol at Screening and Baseline.
-
Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
-
Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
-
Pregnant women.
-
BMI greater than 39.
-
Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
-
Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
-
Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
-
History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
-
At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
-
Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
-
Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rheumatology Associates, P.C. | Birmingham | Alabama | United States | 35205 |
| 2 | Radiant Research | Birmingham | Alabama | United States | 35209 |
| 3 | Alliance Clinical Research | Birmingham | Alabama | United States | 35215 |
| 4 | Shades Mountain Imaging | Birmingham | Alabama | United States | 35216 |
| 5 | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | United States | 35801 |
| 6 | Saadat Ansari, MD Office | Huntsville | Alabama | United States | 35801 |
| 7 | Coastal Clinical Research, Inc. | Mobile | Alabama | United States | 36608 |
| 8 | Office of Vaughn H. Mancha, Jr., MD | Montgomery | Alabama | United States | 36117 |
| 9 | Radiant Research - Phoenix Southeast | Chandler | Arizona | United States | 85225 |
| 10 | Dedicated Clinical Research | Goodyear | Arizona | United States | 85395 |
| 11 | Eclipse Clinical Research | Green Valley | Arizona | United States | 85614 |
| 12 | Midwest Internal Medicine, PLLC | Lake Havasu City | Arizona | United States | 86403 |
| 13 | Arizona Arthritis & Rheumatology Associates, P.C. | Mesa | Arizona | United States | 85202 |
| 14 | Pivotal Research Centers | Mesa | Arizona | United States | 85210 |
| 15 | Arizona Arthritis & Rheumatology Research, PLLC | Paradise Valley | Arizona | United States | 85253 |
| 16 | Pivotal Research Centers | Peoria | Arizona | United States | 85381 |
| 17 | Elite Clinical Studies, LLC | Phoenix | Arizona | United States | 85018 |
| 18 | Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix | Arizona | United States | 85037 |
| 19 | Cochise Clinical Research | Sierra Vista | Arizona | United States | 85635 |
| 20 | Premiere Phamaceutical Research, LLC | Tempe | Arizona | United States | 85282 |
| 21 | Radiant Research | Tucson | Arizona | United States | 85710 |
| 22 | Arizona Research Associates | Tucson | Arizona | United States | 85712-2142 |
| 23 | Quality of Life Medical and Research Center | Tucson | Arizona | United States | 85712 |
| 24 | Tucson Orthopaedic Institute | Tucson | Arizona | United States | 85712 |
| 25 | Little Rock Diagnostic Clinic, PA | Little Rock | Arkansas | United States | 72205 |
| 26 | Little Rock Family Practice Clinic | Little Rock | Arkansas | United States | 72205 |
| 27 | Advanced Clinical Research Institute | Anaheim | California | United States | 92801 |
| 28 | Orange County Clinical Trials, Inc. | Anaheim | California | United States | 92801 |
| 29 | Med Center | Carmichael | California | United States | 95608 |
| 30 | eStudySite | Chula Vista | California | United States | 91911 |
| 31 | Med Investigations, Inc. | Fair Oaks | California | United States | 95628 |
| 32 | Triwest Research | La Mesa | California | United States | 91942 |
| 33 | Lakewood Orthopedic Medical & Surgical Group | Lakewood | California | United States | 90712 |
| 34 | Premier Clinical Research LLC. | Lakewood | California | United States | 90712 |
| 35 | Prohealth Partners | Long Beach | California | United States | 90808 |
| 36 | Peak Health Medical Group, Inc. | Los Angeles | California | United States | 90025 |
| 37 | Synergy Clinical Research Center | National City | California | United States | 91950 |
| 38 | eStudySite | Oceanside | California | United States | 92056 |
| 39 | Desert Medical Group Inc., Desert Oasis Healthcare | Palm Springs | California | United States | 92262 |
| 40 | Advances in Medicine | Rancho Mirage | California | United States | 92270 |
| 41 | Mercy Imaging Center | Sacramento | California | United States | 95823 |
| 42 | Northern Clinical Research | Sacramento | California | United States | 95831 |
| 43 | California Research Foundation | San Diego | California | United States | 92103-6204 |
| 44 | San Diego Arthritis Medical Clinic | San Diego | California | United States | 92108 |
| 45 | Kaiser Permanente Medical Center | San Francisco | California | United States | 94118 |
| 46 | eStudySite | San Jose | California | United States | 95124 |
| 47 | Trinity Clinical Trials | Santa Ana | California | United States | 92701 |
| 48 | Apex Research Institute | Santa Ana | California | United States | 92705 |
| 49 | St. Joseph Medical Associates | Stockton | California | United States | 95204 |
| 50 | Westlake Medical Center | Westlake Village | California | United States | 91361 |
| 51 | Colorado Springs Family Practice | Colorado Springs | Colorado | United States | 80909 |
| 52 | Lynn Institute of the Rockies | Colorado Springs | Colorado | United States | 80909 |
| 53 | Colorado Arthritis Center, PC | Englewood | Colorado | United States | 80113 |
| 54 | Joao MA Nascimento, MD | Bridgeport | Connecticut | United States | 06606 |
| 55 | New England Research Associates, LLC | Trumbull | Connecticut | United States | 06611 |
| 56 | Rheumatology Consultants of Delaware/Delaware Arthritis | Lewes | Delaware | United States | 19958 |
| 57 | Arthritis and Rheumatic Disease Specialties | Aventura | Florida | United States | 33180 |
| 58 | International Physicans Research | Aventura | Florida | United States | 33180 |
| 59 | Surgery Center of Aventura | Aventura | Florida | United States | 33180 |
| 60 | HeartCare | Bradenton | Florida | United States | 34202 |
| 61 | Clinical Research of West Florida, Inc. | Clearwater | Florida | United States | 33765 |
| 62 | Nature Coast Clinical Research | Crystal River | Florida | United States | 34429 |
| 63 | Homestead Clinical Research Group, P.A. | Cutler Bay | Florida | United States | 33189 |
| 64 | Covance CRU, Inc. | Daytona Beach | Florida | United States | 32117 |
| 65 | Robert W. Levin MD | Dunedin | Florida | United States | 34698 |
| 66 | Internal Medicine Associates | Fort Myers | Florida | United States | 33912 |
| 67 | Clinical Physiology Associates, Clinical Study Center | Fort Myers | Florida | United States | 33916 |
| 68 | Research Consultants Group | Hialeah | Florida | United States | 33010 |
| 69 | Palm Springs Research Institute | Hialeah | Florida | United States | 33012 |
| 70 | Jacksonville Center for Clinical Research | Jacksonville | Florida | United States | 32216 |
| 71 | Florida Arthritis | Lake Mary | Florida | United States | 32746 |
| 72 | Pharmax Research Clinic, Inc. | Miami | Florida | United States | 33126 |
| 73 | Community Research Foundation | Miami | Florida | United States | 33155 |
| 74 | International Research Associates, LLC | Miami | Florida | United States | 33183 |
| 75 | Jeffrey Alper MD Research | Naples | Florida | United States | 34102 |
| 76 | American Family Medicine | Ocala | Florida | United States | 34471 |
| 77 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 78 | Sunshine Research Center | Opa-locka | Florida | United States | 33054-3818 |
| 79 | Arthritis Associates | Orlando | Florida | United States | 32804 |
| 80 | Arthritis Research of Florida, Inc. | Palm Harbor | Florida | United States | 34684 |
| 81 | University Clinical Research | Pembroke Pines | Florida | United States | 33024 |
| 82 | Pembroke Clinical Trials | Pemkbroke Pines | Florida | United States | 33028 |
| 83 | Advent Clinical Research Center Inc | Pinellas Park | Florida | United States | 33781 |
| 84 | Advent Clinical Research Centers | Pinellas Park | Florida | United States | 33781 |
| 85 | Berma Research Group | Plantation | Florida | United States | 33324 |
| 86 | Accord Clinical Research, LLC | Port Orange | Florida | United States | 32129 |
| 87 | Dale G. Bramlet, MD, P.L. | Saint Petersburg | Florida | United States | 33713 |
| 88 | HeartCare Research | Sarasota | Florida | United States | 34232 |
| 89 | Kennedy-White Orthopaedic Center | Sarasota | Florida | United States | 34232 |
| 90 | Sarasota Center for Clinical Research | Sarasota | Florida | United States | 34232 |
| 91 | Lovelace Scientific Resources | Sarasota | Florida | United States | 34233 |
| 92 | The Arthritis Specialty Centre | Sarasota | Florida | United States | 34233 |
| 93 | Soutwest Florida Clinical Research Center | Tampa | Florida | United States | 33609-3018 |
| 94 | Stedman Clinical Trials | Tampa | Florida | United States | 33613 |
| 95 | Tampa Medical Group, PA | Tampa | Florida | United States | 33614 |
| 96 | Florida Medical Clinic, PA | Zephyrhills | Florida | United States | 33542 |
| 97 | Perimeter Institute for Clinical Reseach, Inc. | Atlanta | Georgia | United States | 30338 |
| 98 | Laureate Clinical Research Group | Atlanta | Georgia | United States | 30342 |
| 99 | ACCR/Internal Medicine | Roswell | Georgia | United States | 30075 |
| 100 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
| 101 | Institute of Arthritis Research | Idaho Falls | Idaho | United States | 83404 |
| 102 | Idaho Arthritis & Osteoporosis Center, PC | Meridian | Idaho | United States | 83642-6356 |
| 103 | Saltzer Medical Group PA | Nampa | Idaho | United States | 83686 |
| 104 | Rehabilitation Institute of Chicago | Chicago | Illinois | United States | 60611 |
| 105 | Rockford Orthopedic Associates | Rockford | Illinois | United States | 61107 |
| 106 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 107 | Springfield Clinical Research Department | Springfield | Illinois | United States | 62703 |
| 108 | Deerbrook Medical Associates | Vernon Hills | Illinois | United States | 60061 |
| 109 | American Health Network of Indiana, LLC | Avon | Indiana | United States | 46123 |
| 110 | MediSphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
| 111 | Integrated Clinical Trial Services, Inc | West Des Moines | Iowa | United States | 50265 |
| 112 | Vince and Associates Clinical Research | Overland Park | Kansas | United States | 66211 |
| 113 | Vince and Associates Clinical Research | Overland Park | Kansas | United States | 66212 |
| 114 | Center for Arthritis and Osteoporosis | Elizabethtown | Kentucky | United States | 42701 |
| 115 | Pain Treatment Center of the Bluegrass | Lexington | Kentucky | United States | 40503 |
| 116 | Pasadena Pharmacy | Lexington | Kentucky | United States | 40503 |
| 117 | Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | United States | 42431 |
| 118 | Multicare Specialists | Madisonville | Kentucky | United States | 42431 |
| 119 | Gulf Coast Research, LLC | Baton Rouge | Louisiana | United States | 70808 |
| 120 | The Bone and Joint Clinic | Baton Rouge | Louisiana | United States | 70808 |
| 121 | MD Medical Research | Oxon Hill | Maryland | United States | 20745 |
| 122 | Beacon Clinical Research | Brockton | Massachusetts | United States | 02301 |
| 123 | Berkshire Rheumatology | Pittsfield | Massachusetts | United States | 01201 |
| 124 | MedVadis Research Corporation | Watertown | Massachusetts | United States | 02472 |
| 125 | Quest Research Institute | Bingham Farms | Michigan | United States | 48025 |
| 126 | Rheumatology PC | Kalamazoo | Michigan | United States | 49009 |
| 127 | Justus J Fiechtner, MD | Lansing | Michigan | United States | 48910-8595 |
| 128 | PCM Medical Services | Lansing | Michigan | United States | 48917 |
| 129 | Medical Research Associates | Traverse City | Michigan | United States | 49684 |
| 130 | The Center for Clinical Trials | Biloxi | Mississippi | United States | 39531 |
| 131 | Olive Branch Family Medical Center | Olive Branch | Mississippi | United States | 38654 |
| 132 | Highland Community Hospital | Picayune | Mississippi | United States | 39466 |
| 133 | Mississippi Medical Research | Picayune | Mississippi | United States | 39466 |
| 134 | No. County Internal Medicine & Rheumatology | Florissant | Missouri | United States | 63031 |
| 135 | Dynamic Clinical Research, Inc. | Kansas City | Missouri | United States | 64114 |
| 136 | Joan Prouty Moore | Kansas City | Missouri | United States | 64114 |
| 137 | Orthopaedic & Occupational Medicine | Kansas City | Missouri | United States | 64114 |
| 138 | Medex Healthcare Research, Inc. | Saint Louis | Missouri | United States | 63117 |
| 139 | Rheumatology and Internal Medicine Associates of West County, P.C. | Saint Louis | Missouri | United States | 63131 |
| 140 | A & A Pain Institute | Saint Louis | Missouri | United States | 63141 |
| 141 | Arthritis Consultants Inc. | Saint Louis | Missouri | United States | 63141 |
| 142 | Physician Research Collaboration, LLC | Lincoln | Nebraska | United States | 68516 |
| 143 | Westroads Medical Group | Omaha | Nebraska | United States | 68114 |
| 144 | Anderson and Collins Clinical Research Inc. | Edison | New Jersey | United States | 08817 |
| 145 | Central Jersey Medical Research Center | Elizabeth | New Jersey | United States | 07202 |
| 146 | Arthritis & Osteoporosis Associates, P.A. | Freehold | New Jersey | United States | 07728 |
| 147 | Mark Fisher, MD, FACRUC | Haddon Heights | New Jersey | United States | 08035 |
| 148 | New Jersey Physicians, LLC | Passaic | New Jersey | United States | 07055 |
| 149 | Rheumatology Associates of North Jersey | Teaneck | New Jersey | United States | 07666 |
| 150 | Arthritis & Osteoporosis Associates | Toms River | New Jersey | United States | 08757 |
| 151 | Premier Research | Trenton | New Jersey | United States | 08611 |
| 152 | Arthritis, Rheumatic & Back Disease Associates | Voorhees | New Jersey | United States | 08043 |
| 153 | The Center for Rheumatology, LLP | Albany | New York | United States | 12206 |
| 154 | SPRI Bronx LLC | Bronx | New York | United States | 10454 |
| 155 | Arthritis and Osteoporosis Associates of Brooklyn Heights | Brooklyn | New York | United States | 11201 |
| 156 | NYU Hospital for Joint Diseases | New York | New York | United States | 10003 |
| 157 | Prem C. Chatpar, MD, LLC | Plainview | New York | United States | 11803 |
| 158 | Southgate Medical Group | West Seneca | New York | United States | 14224 |
| 159 | Physicians East P. A. | Greenville | North Carolina | United States | 27834 |
| 160 | Physicians East, PA | Greenville | North Carolina | United States | 27834 |
| 161 | Clinical Trials of America, Inc | Hickory | North Carolina | United States | 28601 |
| 162 | Piedmont Rheumatology | Hickory | North Carolina | United States | 28602 |
| 163 | Peters Medical Research | High Point | North Carolina | United States | 27262 |
| 164 | Wake Internal Medicine Consultants Inc | Raleigh | North Carolina | United States | 27612 |
| 165 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 166 | Crescent Medical Research | Salisbury | North Carolina | United States | 28144 |
| 167 | Internal Medicine Associates | Fargo | North Dakota | United States | 58103 |
| 168 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58103 |
| 169 | Daystar Clinical Research, Inc. | Akron | Ohio | United States | 44313 |
| 170 | New Horizons Clinical Research | Cincinnati | Ohio | United States | 45242 |
| 171 | Doctor's Urgent Care Offices | Cincinnati | Ohio | United States | 45246 |
| 172 | Sterling Research Group | Cincinnati | Ohio | United States | 45246 |
| 173 | Columbus Clinical Research, Inc. | Columbus | Ohio | United States | 43213 |
| 174 | Optimed Research, LTD | Columbus | Ohio | United States | 43235 |
| 175 | STAT Research, Inc. | Dayton | Ohio | United States | 45408 |
| 176 | Dayton Science Institute (DSI) | Dayton | Ohio | United States | 45415 |
| 177 | Hometown Urgent Care and Research | Dayton | Ohio | United States | 45432 |
| 178 | PHP - Center for Clinical Research | Dayton | Ohio | United States | 45439 |
| 179 | David R. Mandel, MD, Inc | Mayfield | Ohio | United States | 44143 |
| 180 | Southwest Rheumatology and Research Group, LLC | Middleburg Heights | Ohio | United States | 44130 |
| 181 | Integris Family Care of Norman | Norman | Oklahoma | United States | 73069 |
| 182 | LION Research | Norman | Oklahoma | United States | 73069 |
| 183 | Central Sooner Research | Norman | Oklahoma | United States | 73071 |
| 184 | Elise Wiesner, MD | Norman | Oklahoma | United States | 73071 |
| 185 | McBride Clinic, Inc | Norman | Oklahoma | United States | 73072 |
| 186 | McBride Clinic | Norman | Oklahoma | United States | 73072 |
| 187 | McBride Clinic, Inc | Oklahoma City | Oklahoma | United States | 73013 |
| 188 | Bone and Joint Hospital at St. Anthony | Oklahoma City | Oklahoma | United States | 73103 |
| 189 | Christine Codding, MD | Oklahoma City | Oklahoma | United States | 73103 |
| 190 | Health Research of Oklahoma | Oklahoma City | Oklahoma | United States | 73103 |
| 191 | Mc Bride Clinic | Oklahoma City | Oklahoma | United States | 73103 |
| 192 | Lynn Health Science Institute | Oklahoma City | Oklahoma | United States | 73112 |
| 193 | Associated Orthopedics, Inc. | Oklahoma City | Oklahoma | United States | 73119 |
| 194 | Hillcrest Clinical Research | Oklahoma City | Oklahoma | United States | 73119 |
| 195 | Rheumatology Associates Inc | Tulsa | Oklahoma | United States | 74136 |
| 196 | Aquilo Clinical Research | Yukon | Oklahoma | United States | 73099 |
| 197 | Bend Memorial Clinic | Bend | Oregon | United States | 97701 |
| 198 | Bend Memorial Clinic | Bend | Oregon | United States | 97702 |
| 199 | Blair Orthopedics Associates | Altoona | Pennsylvania | United States | 16602 |
| 200 | Clinical Trials Research Services, LLC | Pittsburgh | Pennsylvania | United States | 15206 |
| 201 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 202 | The Family Healthcare Center, PA | Clinton | South Carolina | United States | 29325 |
| 203 | Columbia Arthritis Center P.A. | Columbia | South Carolina | United States | 29204 |
| 204 | Southern Orthopaedic Sports Medicine | Columbia | South Carolina | United States | 29204 |
| 205 | Radiant Research Inc | Greer | South Carolina | United States | 29651 |
| 206 | The Carolina Center for Rheumatology and Arthritis Care, PA | Rock Hill | South Carolina | United States | 29732 |
| 207 | Regional Health Clinical Research | Rapid City | South Dakota | United States | 57701 |
| 208 | Regional Medical Clinical-Rheumatology | Rapid City | South Dakota | United States | 57701 |
| 209 | Arthritis Clinic | Jackson | Tennessee | United States | 38305 |
| 210 | Ramesh C. Gupta, M.D. | Memphis | Tennessee | United States | 38119 |
| 211 | Abilene Arthritis Center | Abilene | Texas | United States | 79601 |
| 212 | Tekton Research, Inc. | Austin | Texas | United States | 78745 |
| 213 | Dr. Paul K. Pickrell (Physician's Office) | Austin | Texas | United States | 78746 |
| 214 | Metroplex Clinical Research Center | Dallas | Texas | United States | 75231 |
| 215 | One Step Diagnostic | Houston | Texas | United States | 77030 |
| 216 | Accurate Clinical Research | Houston | Texas | United States | 77034 |
| 217 | Miracle Medical Center | Houston | Texas | United States | 77055 |
| 218 | DM Clinical Research | Houston | Texas | United States | 77070 |
| 219 | Gill Orthopedic Center | Lubbock | Texas | United States | 79410 |
| 220 | Robert R. King, M.D. | Lubbock | Texas | United States | 79410 |
| 221 | Southwest Rheumatology, PA | Mesquite | Texas | United States | 75150 |
| 222 | Hill Country Medical Associates | New Braunfels | Texas | United States | 78130 |
| 223 | Neurology Clinic of Central Texas | New Braunfels | Texas | United States | 78130 |
| 224 | Philip Blum | Pasadena | Texas | United States | 77504 |
| 225 | Pearland Primary Care Associates | Pearland | Texas | United States | 77584 |
| 226 | Southwest Clinical Research Centers, LLC | Pearland | Texas | United States | 77584 |
| 227 | Plano Primary Care Clinic | Plano | Texas | United States | 75075 |
| 228 | Advanced Family Medical Care | Plano | Texas | United States | 75093 |
| 229 | Alamo Clinical Research Associates | San Antonio | Texas | United States | 78212 |
| 230 | Alamo Clinical Research Consultants | San Antonio | Texas | United States | 78212 |
| 231 | Texas Arthritis Research Center, PA | San Antonio | Texas | United States | 78217 |
| 232 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
| 233 | Innovative Clinical Trials | San Antonio | Texas | United States | 78229 |
| 234 | Radiant Research San Antonio | San Antonio | Texas | United States | 78229 |
| 235 | SAM Clinical Research Center | San Antonio | Texas | United States | 78229 |
| 236 | San Antonio Preventive & Diagnostic Medicine, PA | San Antonio | Texas | United States | 78229 |
| 237 | South Texas Radiology Imaging Center | San Antonio | Texas | United States | 78229 |
| 238 | The Rehab Group | San Antonio | Texas | United States | 78229 |
| 239 | Sugar Land Med-Ped, PA | Sugar Land | Texas | United States | 77479 |
| 240 | Scott & White Healthcare | Temple | Texas | United States | 76508 |
| 241 | Martin Diagnostic Clinic | Tomball | Texas | United States | 77375 |
| 242 | Pivotal Research Centers | Midvale | Utah | United States | 84047 |
| 243 | Optimum Clinical Research, Inc. | Salt Lake City | Utah | United States | 84102 |
| 244 | Radiant Research, Inc. | Salt Lake City | Utah | United States | 84107 |
| 245 | Doris M. Rice, M.D., F.A.C.R. | Portsmouth | Virginia | United States | 23701 |
| 246 | National Clinical Research Richmond Inc. | Richmond | Virginia | United States | 23294 |
| 247 | Hypothe Test, LLC | Roanoke | Virginia | United States | 24018 |
| 248 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 249 | Tacoma Center for Arthritis Research, PS | Tacoma | Washington | United States | 98405-2308 |
| 250 | Gundersen Clinic Ltd. | Onalaska | Wisconsin | United States | 54650 |
| 251 | Office of Diane Wilson | Lunenburg | Nova Scotia | Canada | B0J 2C0 |
| 252 | MAC Research Inc. | Hamilton | Ontario | Canada | L8N 2B6 |
| 253 | KW Musculoskeletal Research Inc. | Kitchener | Ontario | Canada | N2M 5N6 |
| 254 | The Arthritis Program Research Group | Newmarket | Ontario | Canada | L3Y 3R7 |
| 255 | SKDS Research Inc. | Newmarket | Ontario | Canada | L3Y 5G8 |
| 256 | Dr. Saeed Shaikh | St. Catharines | Ontario | Canada | L2N 7E4 |
| 257 | Dr. Anil Gupta | Toronto | Ontario | Canada | M9V 4B4 |
| 258 | Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | Canada | J1H 1Z1 |
| 259 | Polyclinique St. Eustache | St. Eustache | Quebec | Canada | J7P 4J2 |
| 260 | Centre de Recherche Musculo-Squelettique | Trois-Rivieres | Quebec | Canada | G8Z 1Y2 |
| 261 | Groupe de Recherche en Rhumatologie et Maladies Osseuses | Quebec | Canada | G1V 3M7 | |
| 262 | Clinique Medicale St-Louis | Quebec | Canada | G1W 4R4 | |
| 263 | Hospital Pablo Tobon Uribe | Medellin | Antioquia | Colombia | |
| 264 | Centro Integral de Reumatologia e Inmunologia CIREI | Bogota | Cundinamarca | Colombia | |
| 265 | Riesgo de Fractura S.A. | Bogota-Cundinamarca | Colombia | ||
| 266 | Clinica Las Americas | Medellin | Colombia | ||
| 267 | Reumatologya S.A. | Medellin | Colombia | ||
| 268 | Krishna Institute of Medical Sciences Ltd., Department of Rheumatology | Secunderabad | Andhra Pradesh | India | 500003 |
| 269 | St. Johns Medical College Hospital, Department of Orthopaedics | Bangalore | Karnataka | India | 560034 |
| 270 | M.S. Ramaiah Memorial Hospital, Department of Orthopaedics | Bangalore | Karnataka | India | 560054 |
| 271 | ChanRe Rheumatology & Immunology Center & Research | Bangalore | Karnataka | India | 560079 |
| 272 | KMC Hospital, Department of Orthopaedics | Mangalore | Karnataka | India | 575 001 |
| 273 | Sancheti Hospital | Pune | Maharashtra | India | 411 005 |
| 274 | PSG Institute of Medical Sciences and Research | Coimbatore | Tamilnadu | India | 641004 |
| 275 | CSM Medical University, Department of Rheumatology | Lucknow | UP | India | 226018 |
| 276 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 700-721 | |
| 277 | Inha University Hospital | Incheon | Korea, Republic of | 400-711 | |
| 278 | Seoul National University Hospital | Seoul | Korea, Republic of | 110-744 | |
| 279 | Hanyang University Hospital | Seoul | Korea, Republic of | 133-792 | |
| 280 | The Catholic University of Korea, Seoul St.Mary's Hospital | Seoul | Korea, Republic of | 137-701 | |
| 281 | URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde" | Guadalajara | Jalisco | Mexico | CP 44280 |
| 282 | Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C. | Coahuila | Mexico | 27000 | |
| 283 | Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum". | Culiacan Sinaloa | Mexico | CP 80230 | |
| 284 | Hospital Aranda de la Parra | Leon Gto | Mexico | C.P. 37000 | |
| 285 | Beneficencia Espanola de la Laguna | Torreon Coahuila | Mexico | CP 27000 | |
| 286 | READE | Amsterdam | Netherlands | 1056 AB | |
| 287 | UMC St. Radboud | Nijmegen | Netherlands | 6525 GA | |
| 288 | UMC Utrecht | Utrecht | Netherlands | 3584 CX | |
| 289 | Cebu Orthopedic Institute | Cebu City | Philippines | 6000 | |
| 290 | Chong Hua Hospital, Medical Arts Center | Cebu City | Philippines | 6000 | |
| 291 | Diaz Building | Cebu City | Philippines | 6000 | |
| 292 | Davao Doctors Hospital, Medical Tower | Davao City | Philippines | 8000 | |
| 293 | Davao Doctors Hospital | Davao City | Philippines | 8000 | |
| 294 | Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center | Manila | Philippines | 1003 | |
| 295 | Chinese General Hospital and Medical Center, Out Patient Department | Manila | Philippines | ||
| 296 | Asian Hospital and Medical Center | Muntinlupa | Philippines | 1780 | |
| 297 | State Healthcare Institution Moscow City Clinical Hospital #4 | Moscow | Russian Federation | 115093 | |
| 298 | State Healthcare Institution: Moscow City Clinical Hospital #7 | Moscow | Russian Federation | 115446 | |
| 299 | Institution Of Russian Academy of Medical Sciences | Moscow | Russian Federation | 115522 | |
| 300 | Saint Petersburg State Medical University named after Pavlov | Saint Petersburg | Russian Federation | 197022 | |
| 301 | Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov | Saint-Petersburg | Russian Federation | 194291 | |
| 302 | Saint-Petersburg State Healthcare Institution "City Hospital #26" | Saint-Petersburg | Russian Federation | 196247 | |
| 303 | 136 Panorama Medical Center | Panorama | Cape Town | South Africa | 7500 |
| 304 | Phelang Private Hospital Research Unit | Mamelodi East | Pretoria | South Africa | 0122 |
| 305 | Tiervlei Trial Center | Bellville | South Africa | ||
| 306 | Worthwhile Clinical Trials | Benoni | South Africa | 1500 | |
| 307 | Josha Research | Bloemfontein | South Africa | 9301 | |
| 308 | Vincent Pallotti Hospital | Cape Town | South Africa | 7405 | |
| 309 | A. Briel | Durbanville | South Africa | 7550 | |
| 310 | Private Practice | Durban | South Africa | 4091 | |
| 311 | Randles Road Medical Center | Durban | South Africa | 4091 | |
| 312 | Origin Clinical Research | Johannesburg | South Africa | 2060 | |
| 313 | Clinresco Centres (Pty) Ltd | Kempton Park | South Africa | 1619 | |
| 314 | Paarl Research Center | Paarl | South Africa | 7646 | |
| 315 | TREAD Research | Parrowvalley | South Africa | 7500 | |
| 316 | Clinical Research Unit | Pretoria | South Africa | 0083 | |
| 317 | Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia | Sabadell | Barcelona | Spain | 08208 |
| 318 | Hospital El Tomillar | Dos Hermanas | Sevilla | Spain | 41700 |
| 319 | Complejo Hospitalario Universitario de A Coruna | A Coruna | Spain | 15006 | |
| 320 | Hospital de Cruces, Servicio de Reumatologia | Barakaldo (Vizcaya) | Spain | 48903 | |
| 321 | Clinica CIMA | Barcelona | Spain | 08034 | |
| 322 | Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA | Barcelona | Spain | 08034 | |
| 323 | Hospital Universitario La Paz, Servicio de Reumatologia | Madrid | Spain | 28046 | |
| 324 | Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia | Santiago De Compostela, A Coruna | Spain | 15705 | |
| 325 | Hospital Nuestra Senora de Valme, Servicio de Reumatologia | Sevilla | Spain | 41014 | |
| 326 | Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine | 58002 | |
| 327 | City Clinical Hospital #5 | Donetsk | Ukraine | 83000 | |
| 328 | V.K. Gusak Institute of Urgent and Recovery Surgery | Donetsk | Ukraine | 83045 | |
| 329 | Kiev City Oleksandrivska Clinical Hospital | Kiev | Ukraine | 01601 | |
| 330 | Kiev City Clinical Hospital #3 | Kiev | Ukraine | 02125 | |
| 331 | State Institution "Research Centre for Radiation Medicine AMS of Ukraine" | Kiev | Ukraine | 03115 | |
| 332 | State Institution "Institute of Gerontology AMS of Ukraine" | Kiev | Ukraine | 04114 | |
| 333 | Municipal institution :Zaporizhzhya Regional Clinical Hospital | Zaporizhzhya | Ukraine | 69600 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00809354
Other Study ID Numbers:
- A4091025
- 2008-004815-37
- OA CONTROLLED SAFETY STUDY
First Posted:
Dec 17, 2008
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Period Title: Overall Study | ||||||||||
| STARTED | 288 | 289 | 286 | 288 | 288 | 256 | 255 | 257 | 256 | 257 |
| Treated | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| COMPLETED | 33 | 31 | 32 | 32 | 32 | 31 | 32 | 19 | 28 | 31 |
| NOT COMPLETED | 255 | 258 | 254 | 256 | 256 | 225 | 223 | 238 | 228 | 226 |
Baseline Characteristics
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. | Total of all reporting groups |
| Overall Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 | 2700 |
| Age, Customized (Count of Participants) | |||||||||||
| 18 to 44 years |
20
7%
|
16
5.6%
|
18
6.4%
|
18
6.3%
|
14
4.9%
|
8
3.1%
|
3
1.2%
|
11
4.3%
|
7
2.8%
|
3
1.2%
|
118
4.4%
|
| 45 to 64 years |
168
58.9%
|
181
62.8%
|
157
56.1%
|
171
59.4%
|
195
68.9%
|
134
52.3%
|
117
46.1%
|
139
54.3%
|
133
52.4%
|
144
56.3%
|
1539
57%
|
| greater than or equal to (>=) 65 years |
97
34%
|
91
31.6%
|
105
37.5%
|
99
34.4%
|
74
26.1%
|
114
44.5%
|
134
52.8%
|
106
41.4%
|
114
44.9%
|
109
42.6%
|
1043
38.6%
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
200
70.2%
|
208
72.2%
|
184
65.7%
|
192
66.7%
|
199
70.3%
|
192
75%
|
184
72.4%
|
179
69.9%
|
177
69.7%
|
189
73.8%
|
1904
70.5%
|
| Male |
85
29.8%
|
80
27.8%
|
96
34.3%
|
96
33.3%
|
84
29.7%
|
64
25%
|
70
27.6%
|
77
30.1%
|
77
30.3%
|
67
26.2%
|
796
29.5%
|
Outcome Measures
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using baseline observation carried forward (BOCF). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Baseline |
6.39
(1.61)
|
6.50
(1.57)
|
6.52
(1.65)
|
6.33
(1.65)
|
6.32
(1.64)
|
6.49
(1.55)
|
6.44
(1.53)
|
6.41
(1.66)
|
6.27
(1.64)
|
6.29
(1.60)
|
| Change at Week 16 |
-1.80
(2.20)
|
-1.97
(2.35)
|
-2.09
(2.19)
|
-2.26
(2.31)
|
-1.34
(2.08)
|
-2.11
(2.51)
|
-2.12
(2.36)
|
-2.28
(2.43)
|
-2.41
(2.54)
|
-1.48
(2.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Square (LS) Mean Difference |
| Estimated Value | -0.92 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to -0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.70 | |
| Confidence Interval |
(2-Sided) 95% -1.06 to -0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.94 to -0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.453 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.61 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.212 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.59 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.94 | |
| Confidence Interval |
(2-Sided) 95% -1.34 to -0.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -1.15 to -0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.98 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.55 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.879 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.43 to 0.37 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.330 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.083 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.360 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.59 to 0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 287 | 280 | 286 | 282 | 255 | 253 | 255 | 253 | 254 |
| Baseline |
6.46
(1.72)
|
6.47
(1.61)
|
6.57
(1.67)
|
6.39
(1.62)
|
6.32
(1.62)
|
6.67
(1.60)
|
6.58
(1.58)
|
6.57
(1.72)
|
6.39
(1.62)
|
6.47
(1.59)
|
| Change at Week 16 |
-1.80
(2.15)
|
-1.84
(2.13)
|
-2.12
(2.19)
|
-2.18
(2.31)
|
-1.28
(1.96)
|
-2.13
(2.34)
|
-2.09
(2.34)
|
-2.27
(2.40)
|
-2.41
(2.43)
|
-1.42
(2.03)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.88 | |
| Confidence Interval |
(2-Sided) 95% -1.23 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.78 | |
| Confidence Interval |
(2-Sided) 95% -1.13 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -0.87 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.824 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.100 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.044 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.565 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.01 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to -0.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.81 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to -0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.980 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.383 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.56 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.312 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.59 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 |
|---|---|
| Description | Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using baseline BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 288 | 280 | 285 | 283 | 256 | 254 | 255 | 253 | 254 |
| Baseline |
3.39
(0.63)
|
3.41
(0.62)
|
3.39
(0.63)
|
3.39
(0.66)
|
3.38
(0.63)
|
3.44
(0.65)
|
3.48
(0.63)
|
3.45
(0.67)
|
3.41
(0.64)
|
3.37
(0.59)
|
| Change at Week 16 |
-0.54
(0.90)
|
-0.63
(0.91)
|
-0.61
(0.89)
|
-0.72
(1.01)
|
-0.53
(0.75)
|
-0.69
(0.86)
|
-0.64
(0.86)
|
-0.76
(0.95)
|
-0.75
(0.90)
|
-0.51
(0.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.32 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.251 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.251 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.961 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.14 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.272 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.271 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.133 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.35 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.34 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.414 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.20 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.277 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.06 to 0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.328 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.864 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.15 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Change at Week 2 |
-0.96
(1.98)
|
-1.00
(2.08)
|
-1.27
(2.03)
|
-0.89
(2.21)
|
-0.90
(1.81)
|
-1.01
(2.15)
|
-0.74
(2.08)
|
-1.08
(2.03)
|
-0.86
(2.22)
|
-0.93
(1.66)
|
| Change at Week 4 |
-1.68
(2.05)
|
-1.87
(1.96)
|
-2.09
(2.13)
|
-1.98
(2.22)
|
-1.14
(2.09)
|
-1.69
(2.39)
|
-1.78
(2.06)
|
-2.07
(2.27)
|
-2.03
(2.27)
|
-1.09
(1.94)
|
| Change at Week 8 |
-1.68
(2.27)
|
-2.08
(2.14)
|
-2.10
(2.25)
|
-2.18
(2.26)
|
-1.13
(2.08)
|
-1.83
(2.35)
|
-2.01
(2.26)
|
-2.23
(2.22)
|
-2.36
(2.34)
|
-1.15
(2.03)
|
| Change at Week 12 |
-1.86
(2.32)
|
-1.95
(2.21)
|
-2.26
(2.21)
|
-2.34
(2.35)
|
-1.23
(2.12)
|
-2.15
(2.44)
|
-2.20
(2.54)
|
-2.28
(2.39)
|
-2.47
(2.40)
|
-1.40
(1.96)
|
| Change at Week 24 |
-1.65
(2.33)
|
-1.82
(2.32)
|
-1.83
(2.19)
|
-1.95
(2.38)
|
-1.32
(2.15)
|
-1.81
(2.46)
|
-2.04
(2.33)
|
-2.10
(2.47)
|
-2.29
(2.56)
|
-1.63
(2.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.927 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.31 to 0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.779 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.798 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.980 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.098 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.709 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% 0.01 to 0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.710 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to 0.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.504 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.183 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.09 to 0.59 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.572 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.337 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.299 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -1.17 to -0.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.89 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -1.01 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -0.85 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.341 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.71 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.349 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.780 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.29 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.95 | |
| Confidence Interval |
(2-Sided) 95% -1.31 to -0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.93 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -0.99 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -0.88 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.562 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.68 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.910 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to 0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to -0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.91 | |
| Confidence Interval |
(2-Sided) 95% -1.27 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.25 to -0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.53 | |
| Confidence Interval |
(2-Sided) 95% -0.88 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.039 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.409 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.461 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.21 | |
| Confidence Interval |
(2-Sided) 95% -1.59 to -0.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.03 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to -0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.80 | |
| Confidence Interval |
(2-Sided) 95% -1.17 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.59 | |
| Confidence Interval |
(2-Sided) 95% -0.97 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.281 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.43 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.331 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.56 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.11 | |
| Confidence Interval |
(2-Sided) 95% -1.47 to -0.75 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.33 to -0.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -1.03 to -0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.62 | |
| Confidence Interval |
(2-Sided) 95% -0.98 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.781 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.71 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.450 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.08 | |
| Confidence Interval |
(2-Sided) 95% -1.47 to -0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.81 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to -0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.73 | |
| Confidence Interval |
(2-Sided) 95% -1.12 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -1.04 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.699 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.408 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.077 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.182 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Change at Week 2 |
-0.96
(1.98)
|
-1.00
(2.08)
|
-1.27
(2.03)
|
-0.89
(2.21)
|
-0.90
(1.81)
|
-1.01
(2.15)
|
-0.74
(2.08)
|
-1.08
(2.03)
|
-0.86
(2.22)
|
-0.93
(1.66)
|
| Change at Week 4 |
-1.66
(2.09)
|
-1.92
(1.96)
|
-2.12
(2.13)
|
-2.05
(2.24)
|
-1.15
(2.12)
|
-1.76
(2.45)
|
-1.73
(2.13)
|
-2.04
(2.35)
|
-2.00
(2.31)
|
-1.10
(1.94)
|
| Change at Week 8 |
-1.76
(2.34)
|
-2.20
(2.17)
|
-2.26
(2.25)
|
-2.36
(2.25)
|
-1.17
(2.16)
|
-1.92
(2.45)
|
-2.07
(2.32)
|
-2.22
(2.34)
|
-2.34
(2.42)
|
-1.17
(2.06)
|
| Change at Week 12 |
-2.04
(2.40)
|
-2.14
(2.24)
|
-2.45
(2.18)
|
-2.56
(2.35)
|
-1.32
(2.26)
|
-2.29
(2.53)
|
-2.32
(2.63)
|
-2.32
(2.50)
|
-2.51
(2.47)
|
-1.40
(2.05)
|
| Change at Week 16 |
-2.00
(2.29)
|
-2.19
(2.37)
|
-2.36
(2.20)
|
-2.56
(2.27)
|
-1.44
(2.22)
|
-2.27
(2.59)
|
-2.23
(2.46)
|
-2.34
(2.54)
|
-2.46
(2.59)
|
-1.50
(2.17)
|
| Change at Week 24 |
-2.04
(2.44)
|
-2.12
(2.37)
|
-2.20
(2.26)
|
-2.33
(2.39)
|
-1.54
(2.38)
|
-2.05
(2.56)
|
-2.25
(2.44)
|
-2.21
(2.59)
|
-2.39
(2.64)
|
-1.69
(2.23)
|
| Change at Week 32 |
-1.94
(2.51)
|
-2.08
(2.40)
|
-2.10
(2.32)
|
-2.33
(2.42)
|
-1.62
(2.38)
|
-2.02
(2.57)
|
-2.14
(2.58)
|
-2.20
(2.61)
|
-2.14
(2.67)
|
-1.62
(2.24)
|
| Change at Week 40 |
-1.90
(2.54)
|
-1.94
(2.50)
|
-1.88
(2.38)
|
-2.12
(2.39)
|
-1.44
(2.38)
|
-1.98
(2.49)
|
-1.99
(2.52)
|
-1.98
(2.62)
|
-2.18
(2.60)
|
-1.54
(2.22)
|
| Change at Week 48 |
-1.86
(2.54)
|
-1.93
(2.51)
|
-1.86
(2.44)
|
-2.08
(2.34)
|
-1.40
(2.38)
|
-1.86
(2.47)
|
-1.93
(2.51)
|
-2.05
(2.58)
|
-2.03
(2.63)
|
-1.45
(2.25)
|
| Change at Week 56 |
-1.84
(2.54)
|
-1.86
(2.49)
|
-1.84
(2.44)
|
-2.03
(2.32)
|
-1.36
(2.34)
|
-1.83
(2.38)
|
-1.72
(2.47)
|
-1.92
(2.55)
|
-2.02
(2.61)
|
-1.48
(2.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.798 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.779 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.057 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.927 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.31 to 0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.980 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.098 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.709 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% 0.01 to 0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.919 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.183 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.504 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.710 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to 0.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.09 to 0.59 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.572 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.337 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.299 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.82 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.71 | |
| Confidence Interval |
(2-Sided) 95% -1.05 to -0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.91 | |
| Confidence Interval |
(2-Sided) 95% -1.25 to -0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.23 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.177 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.42 | |
| Confidence Interval |
(2-Sided) 95% -0.76 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.286 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.952 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to -0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.57 | |
| Confidence Interval |
(2-Sided) 95% -0.94 to -0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.89 | |
| Confidence Interval |
(2-Sided) 95% -1.26 to -0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.92 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.972 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.096 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.69 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.069 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.902 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.57 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.33 to -0.61 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.02 | |
| Confidence Interval |
(2-Sided) 95% -1.38 to -0.66 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.19 | |
| Confidence Interval |
(2-Sided) 95% -1.55 to -0.84 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.75 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.217 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.351 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.66 | |
| Confidence Interval |
(2-Sided) 95% -1.05 to -0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.83 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.00 | |
| Confidence Interval |
(2-Sided) 95% -1.38 to -0.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.19 | |
| Confidence Interval |
(2-Sided) 95% -1.57 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.389 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.072 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.340 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.69 | |
| Confidence Interval |
(2-Sided) 95% -1.06 to -0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -1.11 to -0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.42 to -0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.23 | |
| Confidence Interval |
(2-Sided) 95% -1.59 to -0.87 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.762 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.84 to -0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.335 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.78 | |
| Confidence Interval |
(2-Sided) 95% -1.18 to -0.38 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to -0.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.85 | |
| Confidence Interval |
(2-Sided) 95% -1.25 to -0.46 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.13 | |
| Confidence Interval |
(2-Sided) 95% -1.52 to -0.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.782 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.719 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.158 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 95% -0.69 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.183 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.67 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 65
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -0.54 | |
| Confidence Interval |
(2-Sided) 95% -0.90 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 66
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -0.69 | |
| Confidence Interval |
(2-Sided) 95% -1.05 to -0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 67
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to 0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 68
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -1.12 | |
| Confidence Interval |
(2-Sided) 95% -1.48 to -0.76 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 69
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.408 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.21 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 70
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.097 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.67 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 71
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.43 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 72
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.132 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 73
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -1.08 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 74
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.66 | |
| Confidence Interval |
(2-Sided) 95% -1.07 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 75
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.78 | |
| Confidence Interval |
(2-Sided) 95% -1.19 to -0.37 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 76
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 95% -1.37 to -0.55 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 77
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.959 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 78
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.618 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 79
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.149 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.71 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
Statistical Analysis 80
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.370 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.21 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 255 | 253 | 255 | 253 | 254 |
| Change at Week 2 |
-1.10
(1.88)
|
-1.13
(1.90)
|
-1.44
(2.02)
|
-1.06
(2.07)
|
-0.90
(1.69)
|
-1.18
(2.01)
|
-0.95
(1.99)
|
-1.21
(1.96)
|
-1.02
(2.13)
|
-0.90
(1.67)
|
| Change at Week 4 |
-1.71
(2.00)
|
-1.79
(1.88)
|
-2.04
(2.16)
|
-2.00
(2.06)
|
-1.01
(1.90)
|
-1.73
(2.23)
|
-1.78
(2.06)
|
-1.97
(2.19)
|
-2.00
(2.13)
|
-1.07
(1.83)
|
| Change at Week 8 |
-1.62
(2.19)
|
-2.01
(2.04)
|
-2.05
(2.26)
|
-2.15
(2.19)
|
-1.07
(1.87)
|
-1.89
(2.27)
|
-2.00
(2.17)
|
-2.15
(2.19)
|
-2.30
(2.22)
|
-1.13
(1.94)
|
| Change at Week 12 |
-1.85
(2.25)
|
-1.87
(2.06)
|
-2.18
(2.17)
|
-2.29
(2.33)
|
-1.23
(2.00)
|
-2.23
(2.34)
|
-2.13
(2.43)
|
-2.34
(2.36)
|
-2.46
(2.32)
|
-1.36
(1.97)
|
| Change at Week 24 |
-1.66
(2.28)
|
-1.76
(2.16)
|
-1.76
(2.11)
|
-1.96
(2.37)
|
-1.30
(2.03)
|
-1.92
(2.29)
|
-2.00
(2.31)
|
-2.08
(2.37)
|
-2.33
(2.45)
|
-1.57
(2.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.887 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.771 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.34 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.223 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.718 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.495 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.371 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.647 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to 0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.073 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.161 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.961 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.697 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.139 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.120 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.637 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.028 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.024 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -0.74 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.339 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.381 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.438 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.111 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.72 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.282 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.927 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.094 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to -0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.363 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.742 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.32 to 0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.436 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.332 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.224 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.355 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.172 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.882 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.405 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -0.99 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.74 | |
| Confidence Interval |
(2-Sided) 95% -1.06 to -0.42 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.60 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.87 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.95 | |
| Confidence Interval |
(2-Sided) 95% -1.31 to -0.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.52 | |
| Confidence Interval |
(2-Sided) 95% -0.86 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.92 | |
| Confidence Interval |
(2-Sided) 95% -1.26 to -0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.07 | |
| Confidence Interval |
(2-Sided) 95% -1.41 to -0.73 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.70 | |
| Confidence Interval |
(2-Sided) 95% -1.06 to -0.33 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -1.21 to -0.47 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.99 | |
| Confidence Interval |
(2-Sided) 95% -1.36 to -0.63 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.19 | |
| Confidence Interval |
(2-Sided) 95% -1.56 to -0.83 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to -0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.88 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.88 | |
| Confidence Interval |
(2-Sided) 95% -1.24 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.05 | |
| Confidence Interval |
(2-Sided) 95% -1.40 to -0.70 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.79 | |
| Confidence Interval |
(2-Sided) 95% -1.17 to -0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.72 | |
| Confidence Interval |
(2-Sided) 95% -1.11 to -0.34 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.94 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.13 | |
| Confidence Interval |
(2-Sided) 95% -1.51 to -0.75 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 287 | 280 | 286 | 282 | 255 | 253 | 255 | 253 | 254 |
| Baseline |
6.46
(1.72)
|
6.47
(1.61)
|
6.57
(1.67)
|
6.39
(1.62)
|
6.32
(1.62)
|
6.67
(1.60)
|
6.58
(1.58)
|
6.57
(1.72)
|
6.39
(1.62)
|
6.47
(1.59)
|
| Change at Week 2 |
-1.10
(1.88)
|
-1.13
(1.90)
|
-1.44
(2.02)
|
-1.06
(2.07)
|
-0.90
(1.69)
|
-1.18
(2.01)
|
-0.95
(1.99)
|
-1.21
(1.96)
|
-1.02
(2.13)
|
-0.90
(1.67)
|
| Change at Week 4 |
-1.70
(2.02)
|
-1.84
(1.87)
|
-2.08
(2.15)
|
-2.06
(2.11)
|
-1.04
(1.91)
|
-1.81
(2.30)
|
-1.75
(2.10)
|
-1.95
(2.24)
|
-1.91
(2.18)
|
-1.09
(1.83)
|
| Change at Week 8 |
-1.69
(2.23)
|
-2.13
(2.06)
|
-2.23
(2.26)
|
-2.33
(2.21)
|
-1.11
(1.95)
|
-2.02
(2.37)
|
-2.08
(2.19)
|
-2.13
(2.29)
|
-2.29
(2.30)
|
-1.14
(1.96)
|
| Change at Week 12 |
-2.02
(2.31)
|
-2.08
(2.12)
|
-2.40
(2.15)
|
-2.50
(2.36)
|
-1.31
(2.11)
|
-2.35
(2.48)
|
-2.31
(2.46)
|
-2.37
(2.44)
|
-2.50
(2.42)
|
-1.36
(2.05)
|
| Change at Week 24 |
-2.04
(2.37)
|
-2.08
(2.22)
|
-2.22
(2.21)
|
-2.29
(2.46)
|
-1.49
(2.22)
|
-2.14
(2.42)
|
-2.24
(2.31)
|
-2.20
(2.45)
|
-2.44
(2.54)
|
-1.62
(2.22)
|
| Change at Week 32 |
-1.87
(2.40)
|
-2.01
(2.29)
|
-2.15
(2.32)
|
-2.25
(2.46)
|
-1.53
(2.29)
|
-2.08
(2.47)
|
-2.16
(2.42)
|
-2.22
(2.56)
|
-2.20
(2.62)
|
-1.57
(2.23)
|
| Change at Week 40 |
-1.87
(2.37)
|
-1.90
(2.40)
|
-1.95
(2.34)
|
-2.04
(2.48)
|
-1.44
(2.23)
|
-2.06
(2.48)
|
-2.04
(2.40)
|
-2.00
(2.59)
|
-2.18
(2.60)
|
-1.52
(2.24)
|
| Change at Week 48 |
-1.82
(2.36)
|
-1.93
(2.43)
|
-1.90
(2.41)
|
-1.96
(2.39)
|
-1.39
(2.25)
|
-1.94
(2.44)
|
-1.97
(2.42)
|
-2.03
(2.56)
|
-2.05
(2.58)
|
-1.44
(2.23)
|
| Change at Week 56 |
-1.82
(2.36)
|
-1.84
(2.41)
|
-1.88
(2.41)
|
-1.87
(2.38)
|
-1.34
(2.22)
|
-1.90
(2.36)
|
-1.78
(2.36)
|
-1.92
(2.54)
|
-2.05
(2.57)
|
-1.45
(2.24)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.887 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.046 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.771 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.34 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.223 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.54 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.718 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.495 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.389 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.035 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.68 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.155 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.56 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.876 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.35 to 0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.864 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to 0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.338 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.101 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.605 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.43 | |
| Confidence Interval |
(2-Sided) 95% -0.78 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.50 | |
| Confidence Interval |
(2-Sided) 95% -0.84 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.199 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.363 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.613 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.416 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.143 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.245 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.745 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.062 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.34 | |
| Confidence Interval |
(2-Sided) 95% -0.69 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.367 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.52 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.995 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.735 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.46 to 0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.169 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.67 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.295 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to 0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.224 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.355 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to 0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.172 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.882 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.29 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.405 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.62 | |
| Confidence Interval |
(2-Sided) 95% -0.94 to -0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.76 | |
| Confidence Interval |
(2-Sided) 95% -1.09 to -0.44 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.30 to -0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.00 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.17 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.66 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -0.99 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.83 | |
| Confidence Interval |
(2-Sided) 95% -1.19 to -0.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.93 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.57 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.54 | |
| Confidence Interval |
(2-Sided) 95% -0.89 to -0.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.98 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.63 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.04 | |
| Confidence Interval |
(2-Sided) 95% -1.39 to -0.70 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.20 | |
| Confidence Interval |
(2-Sided) 95% -1.55 to -0.86 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.80 | |
| Confidence Interval |
(2-Sided) 95% -1.18 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 95% -1.33 to -0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -1.56 to -0.81 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.19 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.66 | |
| Confidence Interval |
(2-Sided) 95% -1.02 to -0.31 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.72 | |
| Confidence Interval |
(2-Sided) 95% -1.08 to -0.37 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.00 | |
| Confidence Interval |
(2-Sided) 95% -1.36 to -0.65 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.17 | |
| Confidence Interval |
(2-Sided) 95% -1.52 to -0.81 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.18 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.90 | |
| Confidence Interval |
(2-Sided) 95% -1.30 to -0.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.36 to -0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -1.57 to -0.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.20 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 288 | 280 | 285 | 283 | 256 | 254 | 255 | 253 | 254 |
| Change at Week 2 |
-0.45
(0.80)
|
-0.42
(0.83)
|
-0.50
(0.81)
|
-0.40
(0.92)
|
-0.39
(0.71)
|
-0.46
(0.89)
|
-0.33
(0.88)
|
-0.45
(0.89)
|
-0.26
(0.85)
|
-0.37
(0.75)
|
| Change at Week 4 |
-0.60
(0.78)
|
-0.69
(0.81)
|
-0.74
(0.86)
|
-0.68
(0.87)
|
-0.43
(0.80)
|
-0.68
(0.88)
|
-0.75
(0.92)
|
-0.80
(0.92)
|
-0.75
(0.84)
|
-0.49
(0.85)
|
| Change at Week 8 |
-0.58
(0.89)
|
-0.70
(0.84)
|
-0.69
(0.87)
|
-0.82
(0.90)
|
-0.45
(0.81)
|
-0.63
(0.89)
|
-0.69
(0.85)
|
-0.81
(0.92)
|
-0.79
(0.82)
|
-0.51
(0.87)
|
| Change at Week 12 |
-0.60
(0.89)
|
-0.68
(0.85)
|
-0.69
(0.88)
|
-0.84
(0.99)
|
-0.46
(0.89)
|
-0.71
(0.86)
|
-0.75
(0.88)
|
-0.77
(0.93)
|
-0.83
(0.89)
|
-0.54
(0.83)
|
| Change at Week 24 |
-0.58
(0.97)
|
-0.54
(0.93)
|
-0.50
(0.82)
|
-0.60
(0.99)
|
-0.49
(0.82)
|
-0.57
(0.89)
|
-0.59
(0.82)
|
-0.67
(0.99)
|
-0.74
(0.90)
|
-0.55
(0.84)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.469 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.08 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.387 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.887 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.01 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.783 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.762 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.207 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.20 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.020 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.941 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.494 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.089 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.467 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.774 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.315 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.06 to 0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.088 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.066 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.073 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.682 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to -0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.871 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.14 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.301 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.181 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.031 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.874 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.15 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.447 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.19 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.196 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.360 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.845 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.076 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.957 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.12 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.404 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.19 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.577 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.068 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.01 to 0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.43 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to -0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to -0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.31 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.25 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to -0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to -0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.074 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to -0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to -0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to -0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.236 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.112 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to -0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to -0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to -0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.28 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
| Title | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 288 | 280 | 285 | 283 | 256 | 254 | 255 | 253 | 254 |
| Change at Week 2 |
-0.45
(0.80)
|
-0.42
(0.83)
|
-0.50
(0.81)
|
-0.40
(0.92)
|
-0.39
(0.71)
|
-0.46
(0.89)
|
-0.33
(0.88)
|
-0.45
(0.89)
|
-0.26
(0.85)
|
-0.37
(0.75)
|
| Change at Week 4 |
-0.60
(0.80)
|
-0.72
(0.82)
|
-0.76
(0.86)
|
-0.72
(0.90)
|
-0.44
(0.80)
|
-0.70
(0.91)
|
-0.76
(0.93)
|
-0.78
(0.95)
|
-0.74
(0.86)
|
-0.51
(0.85)
|
| Change at Week 8 |
-0.63
(0.91)
|
-0.77
(0.87)
|
-0.75
(0.88)
|
-0.86
(0.95)
|
-0.48
(0.83)
|
-0.68
(0.91)
|
-0.74
(0.87)
|
-0.81
(0.94)
|
-0.81
(0.85)
|
-0.54
(0.90)
|
| Change at Week 12 |
-0.67
(0.91)
|
-0.79
(0.89)
|
-0.78
(0.90)
|
-0.91
(1.04)
|
-0.49
(0.93)
|
-0.77
(0.90)
|
-0.84
(0.89)
|
-0.81
(0.95)
|
-0.86
(0.93)
|
-0.57
(0.88)
|
| Change at Week 16 |
-0.63
(0.93)
|
-0.74
(0.95)
|
-0.72
(0.92)
|
-0.79
(1.07)
|
-0.57
(0.81)
|
-0.76
(0.91)
|
-0.73
(0.88)
|
-0.80
(0.96)
|
-0.77
(0.94)
|
-0.54
(0.92)
|
| Change at Week 24 |
-0.69
(1.02)
|
-0.68
(1.00)
|
-0.64
(0.87)
|
-0.69
(1.07)
|
-0.57
(0.89)
|
-0.66
(0.96)
|
-0.69
(0.87)
|
-0.73
(1.02)
|
-0.77
(0.96)
|
-0.59
(0.93)
|
| Change at Week 32 |
-0.60
(0.97)
|
-0.66
(0.95)
|
-0.60
(0.93)
|
-0.68
(1.16)
|
-0.57
(0.96)
|
-0.63
(1.02)
|
-0.66
(0.92)
|
-0.73
(0.91)
|
-0.66
(1.00)
|
-0.57
(0.92)
|
| Change at Week 40 |
-0.58
(0.98)
|
-0.60
(0.98)
|
-0.53
(0.93)
|
-0.56
(1.10)
|
-0.50
(0.91)
|
-0.61
(1.03)
|
-0.67
(0.87)
|
-0.59
(1.00)
|
-0.66
(1.01)
|
-0.57
(0.94)
|
| Change at Week 48 |
-0.53
(0.99)
|
-0.60
(0.98)
|
-0.51
(0.92)
|
-0.48
(1.09)
|
-0.49
(0.91)
|
-0.53
(1.04)
|
-0.62
(0.91)
|
-0.63
(0.98)
|
-0.59
(1.01)
|
-0.54
(0.95)
|
| Change at Week 56 |
-0.53
(1.00)
|
-0.55
(0.95)
|
-0.49
(0.94)
|
-0.46
(1.09)
|
-0.47
(0.89)
|
-0.51
(1.01)
|
-0.56
(0.85)
|
-0.61
(1.00)
|
-0.58
(1.02)
|
-0.54
(0.96)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.469 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.08 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.387 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.887 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.084 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.01 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.018 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.783 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.762 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.11 to 0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.017 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.03 to 0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.29 to -0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.835 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.463 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) 95% -0.08 to 0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.713 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.267 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.552 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.885 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.12 to 0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.47 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to -0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 19
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.117 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 20
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.106 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 21
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.673 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.16 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 22
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.089 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 23
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.065 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 24
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.567 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 25
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 10 mg (Naproxen Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.135 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 26
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Tanezumab 5 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.094 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 27
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.055 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.13 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 28
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Tanezumab 10 mg + Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 29
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 10 mg (Celecoxib Exposure) |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.542 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 30
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Tanezumab 5 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.643 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 31
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.301 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.07 | |
| Confidence Interval |
(2-Sided) 95% -0.21 to 0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 32
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.237 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.08 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 33
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.360 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.18 to 0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 34
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.854 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 35
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.076 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.23 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 36
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.957 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.00 | |
| Confidence Interval |
(2-Sided) 95% -0.12 to 0.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 37
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.404 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.19 to 0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 38
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.03 to 0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 39
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.577 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.17 to 0.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 40
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.068 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.01 to 0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 41
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 42
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.38 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 43
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.31 | |
| Confidence Interval |
(2-Sided) 95% -0.44 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 44
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.06 |
|
| Estimation Comments | ||
Statistical Analysis 45
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.037 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 46
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.015 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 47
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | 0.07 |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.35 to -0.08 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 48
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.34 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 49
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.042 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.27 to -0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 50
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 51
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 52
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.50 to -0.24 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 53
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.182 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.09 | |
| Confidence Interval |
(2-Sided) 95% -0.22 to 0.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 54
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.080 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 55
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.20 | |
| Confidence Interval |
(2-Sided) 95% -0.34 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 56
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to -0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 57
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.016 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.30 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 58
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Naproxen Exposure), Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.40 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 59
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 60
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Naproxen 500 mg, Naproxen 500 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 61
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.15 | |
| Confidence Interval |
(2-Sided) 95% -0.29 to -0.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 62
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg (Celecoxib Exposure), Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.33 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 63
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 5 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.32 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
Statistical Analysis 64
| Statistical Analysis Overview | Comparison Group Selection | Tanezumab 10 mg + Celecoxib 100 mg, Celecoxib 100 mg |
|---|---|---|
| Comments | Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS mean difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.41 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.07 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). |
| Time Frame | Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2 |
40.4
14.2%
|
35.5
12.3%
|
43.2
15.4%
|
36.1
12.5%
|
31.8
11.2%
|
39.6
15.5%
|
33.9
13.3%
|
39.5
15.4%
|
33.1
13%
|
32.4
12.7%
|
| Week 4 |
53.0
18.6%
|
57.6
20%
|
60.7
21.7%
|
54.5
18.9%
|
39.7
14%
|
51.6
20.2%
|
55.5
21.9%
|
57.4
22.4%
|
57.5
22.6%
|
41.0
16%
|
| Week 8 |
49.5
17.4%
|
58.9
20.5%
|
60.4
21.6%
|
58.3
20.2%
|
39.0
13.8%
|
53.9
21.1%
|
57.5
22.6%
|
59.4
23.2%
|
65.0
25.6%
|
42.6
16.6%
|
| Week 12 |
54.0
18.9%
|
56.1
19.5%
|
61.4
21.9%
|
61.1
21.2%
|
42.9
15.2%
|
56.6
22.1%
|
59.1
23.3%
|
62.1
24.3%
|
65.7
25.9%
|
45.3
17.7%
|
| Week 16 |
52.3
18.4%
|
53.0
18.4%
|
56.8
20.3%
|
60.1
20.9%
|
45.2
16%
|
55.1
21.5%
|
55.9
22%
|
59.8
23.4%
|
63.4
25%
|
47.3
18.5%
|
| Week 24 |
48.1
16.9%
|
50.9
17.7%
|
51.4
18.4%
|
51.0
17.7%
|
41.1
14.5%
|
49.8
19.5%
|
53.5
21.1%
|
54.7
21.4%
|
59.4
23.4%
|
49.2
19.2%
|
| Title | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). |
| Time Frame | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2 |
40.4
14.2%
|
35.5
12.3%
|
43.2
15.4%
|
36.1
12.5%
|
31.8
11.2%
|
39.6
15.5%
|
33.9
13.3%
|
39.5
15.4%
|
33.1
13%
|
32.4
12.7%
|
| Week 4 |
53.7
18.8%
|
59.0
20.5%
|
62.5
22.3%
|
57.6
20%
|
41.0
14.5%
|
53.1
20.7%
|
55.9
22%
|
57.8
22.6%
|
57.9
22.8%
|
41.8
16.3%
|
| Week 8 |
53.3
18.7%
|
62.2
21.6%
|
65.7
23.5%
|
64.2
22.3%
|
41.0
14.5%
|
56.3
22%
|
61.4
24.2%
|
61.3
23.9%
|
66.5
26.2%
|
43.8
17.1%
|
| Week 12 |
60.4
21.2%
|
61.8
21.5%
|
68.2
24.4%
|
68.4
23.8%
|
46.6
16.5%
|
60.9
23.8%
|
65.0
25.6%
|
65.6
25.6%
|
68.1
26.8%
|
47.7
18.6%
|
| Week 16 |
59.3
20.8%
|
59.7
20.7%
|
65.7
23.5%
|
69.1
24%
|
49.5
17.5%
|
60.5
23.6%
|
62.2
24.5%
|
64.1
25%
|
66.5
26.2%
|
51.2
20%
|
| Week 24 |
60.4
21.2%
|
60.1
20.9%
|
63.2
22.6%
|
62.2
21.6%
|
48.4
17.1%
|
58.6
22.9%
|
63.4
25%
|
60.5
23.6%
|
64.2
25.3%
|
55.1
21.5%
|
| Week 32 |
60.7
21.3%
|
57.6
20%
|
61.4
21.9%
|
63.2
21.9%
|
52.3
18.5%
|
57.4
22.4%
|
56.3
22.2%
|
62.5
24.4%
|
60.6
23.9%
|
53.1
20.7%
|
| Week 40 |
57.9
20.3%
|
56.3
19.5%
|
58.9
21%
|
59.0
20.5%
|
50.9
18%
|
58.2
22.7%
|
56.3
22.2%
|
57.4
22.4%
|
62.2
24.5%
|
49.2
19.2%
|
| Week 48 |
58.2
20.4%
|
57.6
20%
|
57.9
20.7%
|
58.0
20.1%
|
49.5
17.5%
|
57.4
22.4%
|
55.9
22%
|
58.2
22.7%
|
58.3
23%
|
49.2
19.2%
|
| Week 56 |
57.2
20.1%
|
54.9
19.1%
|
57.5
20.5%
|
58.0
20.1%
|
50.5
17.8%
|
56.6
22.1%
|
53.5
21.1%
|
57.0
22.3%
|
59.4
23.4%
|
49.2
19.2%
|
| Title | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2: >=30% Reduction |
28.4
10%
|
26.8
9.3%
|
35.0
12.5%
|
24.9
8.6%
|
22.7
8%
|
28.0
10.9%
|
22.8
9%
|
30.6
12%
|
26.0
10.2%
|
24.7
9.6%
|
| Week 2: >=50% Reduction |
17.5
6.1%
|
17.1
5.9%
|
20.4
7.3%
|
16.1
5.6%
|
12.8
4.5%
|
12.6
4.9%
|
13.8
5.4%
|
17.3
6.8%
|
18.5
7.3%
|
11.0
4.3%
|
| Week 2: >=70% Reduction |
5.6
2%
|
8.7
3%
|
6.4
2.3%
|
7.4
2.6%
|
5.3
1.9%
|
7.1
2.8%
|
6.3
2.5%
|
7.8
3%
|
8.3
3.3%
|
5.5
2.1%
|
| Week 2: >=90% Reduction |
1.1
0.4%
|
1.4
0.5%
|
2.9
1%
|
1.8
0.6%
|
1.1
0.4%
|
2.4
0.9%
|
1.2
0.5%
|
1.2
0.5%
|
3.1
1.2%
|
1.6
0.6%
|
| Week 4: >=30% Reduction |
40.7
14.3%
|
45.6
15.8%
|
52.1
18.6%
|
47.7
16.6%
|
29.8
10.5%
|
39.8
15.5%
|
41.7
16.4%
|
49.0
19.1%
|
50.4
19.8%
|
31.0
12.1%
|
| Week 4: >=50% Reduction |
24.6
8.6%
|
30.0
10.4%
|
27.5
9.8%
|
32.3
11.2%
|
19.5
6.9%
|
22.4
8.8%
|
26.0
10.2%
|
30.2
11.8%
|
32.7
12.9%
|
18.4
7.2%
|
| Week 4: >=70% Reduction |
11.9
4.2%
|
12.5
4.3%
|
15.0
5.4%
|
17.5
6.1%
|
6.7
2.4%
|
13.8
5.4%
|
11.4
4.5%
|
16.5
6.4%
|
19.3
7.6%
|
7.1
2.8%
|
| Week 4: >=90% Reduction |
2.1
0.7%
|
3.1
1.1%
|
6.8
2.4%
|
4.2
1.5%
|
2.5
0.9%
|
4.3
1.7%
|
3.9
1.5%
|
6.3
2.5%
|
5.5
2.2%
|
1.0
0.4%
|
| Week 8: >=30% Reduction |
43.9
15.4%
|
49.8
17.3%
|
49.3
17.6%
|
49.8
17.3%
|
29.8
10.5%
|
44.1
17.2%
|
45.7
18%
|
51.0
19.9%
|
55.9
22%
|
30.2
11.8%
|
| Week 8: >=50% Reduction |
27.7
9.7%
|
33.8
11.7%
|
29.6
10.6%
|
35.1
12.2%
|
16.7
5.9%
|
27.2
10.6%
|
29.9
11.8%
|
33.7
13.2%
|
36.2
14.3%
|
18.8
7.3%
|
| Week 8: >=70% Reduction |
13.7
4.8%
|
16.4
5.7%
|
18.2
6.5%
|
21.1
7.3%
|
8.2
2.9%
|
13.8
5.4%
|
16.5
6.5%
|
18.8
7.3%
|
23.2
9.1%
|
9.0
3.5%
|
| Week 8: >=90% Reduction |
4.2
1.5%
|
3.8
1.3%
|
6.4
2.3%
|
7.7
2.7%
|
2.1
0.7%
|
5.1
2%
|
6.7
2.6%
|
6.3
2.5%
|
7.1
2.8%
|
2.7
1.1%
|
| Week 12: >=30% Reduction |
45.6
16%
|
46.3
16.1%
|
53.2
19%
|
54.4
18.9%
|
34.0
12%
|
48.0
18.8%
|
52.0
20.5%
|
53.7
21%
|
58.3
23%
|
36.5
14.3%
|
| Week 12: >=50% Reduction |
30.2
10.6%
|
32.8
11.4%
|
32.1
11.5%
|
39.3
13.6%
|
19.5
6.9%
|
33.5
13.1%
|
35.8
14.1%
|
37.6
14.7%
|
41.7
16.4%
|
21.6
8.4%
|
| Week 12: >=70% Reduction |
14.4
5.1%
|
16.0
5.6%
|
18.6
6.6%
|
23.9
8.3%
|
7.8
2.8%
|
19.3
7.5%
|
19.3
7.6%
|
20.8
8.1%
|
23.6
9.3%
|
9.0
3.5%
|
| Week 12: >=90% Reduction |
6.3
2.2%
|
6.3
2.2%
|
6.8
2.4%
|
9.8
3.4%
|
2.8
1%
|
4.7
1.8%
|
7.9
3.1%
|
7.1
2.8%
|
10.6
4.2%
|
2.4
0.9%
|
| Week 16: >=30% Reduction |
44.6
15.6%
|
47.0
16.3%
|
49.6
17.7%
|
54.0
18.8%
|
36.2
12.8%
|
48.0
18.8%
|
48.8
19.2%
|
52.9
20.7%
|
54.3
21.4%
|
39.2
15.3%
|
| Week 16: >=50% Reduction |
27.4
9.6%
|
32.8
11.4%
|
34.3
12.3%
|
36.5
12.7%
|
19.9
7%
|
35.0
13.7%
|
35.0
13.8%
|
37.6
14.7%
|
42.5
16.7%
|
24.3
9.5%
|
| Week 16: >=70% Reduction |
15.1
5.3%
|
17.4
6%
|
15.0
5.4%
|
24.9
8.6%
|
7.8
2.8%
|
20.1
7.9%
|
18.1
7.1%
|
22.0
8.6%
|
24.8
9.8%
|
9.8
3.8%
|
| Week 16: >=90% Reduction |
6.0
2.1%
|
6.3
2.2%
|
6.8
2.4%
|
8.4
2.9%
|
2.5
0.9%
|
7.5
2.9%
|
5.9
2.3%
|
7.8
3%
|
12.6
5%
|
2.7
1.1%
|
| Week 24: >=30% Reduction |
40.4
14.2%
|
44.9
15.6%
|
44.3
15.8%
|
46.0
16%
|
36.5
12.9%
|
42.5
16.6%
|
46.5
18.3%
|
47.1
18.4%
|
53.5
21.1%
|
41.6
16.3%
|
| Week 24: >=50% Reduction |
27.7
9.7%
|
31.7
11%
|
28.2
10.1%
|
34.4
11.9%
|
21.3
7.5%
|
30.3
11.8%
|
33.5
13.2%
|
35.3
13.8%
|
41.3
16.3%
|
25.9
10.1%
|
| Week 24: >=70% Reduction |
14.0
4.9%
|
17.4
6%
|
16.4
5.9%
|
21.4
7.4%
|
11.7
4.1%
|
15.4
6%
|
18.5
7.3%
|
21.6
8.4%
|
23.6
9.3%
|
11.4
4.5%
|
| Week 24: >=90% Reduction |
6.7
2.4%
|
7.3
2.5%
|
6.4
2.3%
|
6.0
2.1%
|
3.5
1.2%
|
7.5
2.9%
|
7.1
2.8%
|
7.5
2.9%
|
11.8
4.6%
|
3.9
1.5%
|
| Title | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. |
| Time Frame | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2: >=30% Reduction |
28.4
10%
|
26.8
9.3%
|
35.0
12.5%
|
24.9
8.6%
|
22.7
8%
|
28.0
10.9%
|
22.8
9%
|
30.6
12%
|
26.0
10.2%
|
24.7
9.6%
|
| Week 2: >=50% Reduction |
17.5
6.1%
|
17.1
5.9%
|
20.4
7.3%
|
16.1
5.6%
|
12.8
4.5%
|
12.6
4.9%
|
13.8
5.4%
|
17.3
6.8%
|
18.5
7.3%
|
11.0
4.3%
|
| Week 2: >=70% Reduction |
5.6
2%
|
8.7
3%
|
6.4
2.3%
|
7.4
2.6%
|
5.3
1.9%
|
7.1
2.8%
|
6.3
2.5%
|
7.8
3%
|
8.3
3.3%
|
5.5
2.1%
|
| Week 2: >=90% Reduction |
1.1
0.4%
|
1.4
0.5%
|
2.9
1%
|
1.8
0.6%
|
1.1
0.4%
|
2.4
0.9%
|
1.2
0.5%
|
1.2
0.5%
|
3.1
1.2%
|
1.6
0.6%
|
| Week 4: >=30% Reduction |
41.1
14.4%
|
46.3
16.1%
|
53.2
19%
|
49.8
17.3%
|
30.5
10.8%
|
41.3
16.1%
|
41.7
16.4%
|
49.8
19.5%
|
50.4
19.8%
|
31.0
12.1%
|
| Week 4: >=50% Reduction |
24.6
8.6%
|
30.7
10.7%
|
27.9
10%
|
33.7
11.7%
|
20.2
7.1%
|
23.6
9.2%
|
26.0
10.2%
|
30.6
12%
|
32.7
12.9%
|
18.4
7.2%
|
| Week 4: >=70% Reduction |
11.9
4.2%
|
12.5
4.3%
|
15.0
5.4%
|
17.9
6.2%
|
6.7
2.4%
|
14.2
5.5%
|
11.4
4.5%
|
16.9
6.6%
|
19.3
7.6%
|
7.1
2.8%
|
| Week 4: >=90% Reduction |
2.1
0.7%
|
3.1
1.1%
|
6.8
2.4%
|
4.6
1.6%
|
2.5
0.9%
|
4.7
1.8%
|
3.9
1.5%
|
6.3
2.5%
|
5.5
2.2%
|
1.0
0.4%
|
| Week 8: >=30% Reduction |
46.3
16.2%
|
51.9
18%
|
53.9
19.3%
|
55.1
19.1%
|
31.2
11%
|
46.5
18.2%
|
48.8
19.2%
|
52.9
20.7%
|
56.7
22.3%
|
31.0
12.1%
|
| Week 8: >=50% Reduction |
29.1
10.2%
|
35.2
12.2%
|
31.4
11.2%
|
38.9
13.5%
|
17.7
6.3%
|
28.7
11.2%
|
30.7
12.1%
|
34.5
13.5%
|
37.0
14.6%
|
18.8
7.3%
|
| Week 8: >=70% Reduction |
14.4
5.1%
|
16.7
5.8%
|
19.3
6.9%
|
22.8
7.9%
|
8.5
3%
|
14.6
5.7%
|
17.3
6.8%
|
19.2
7.5%
|
23.6
9.3%
|
9.0
3.5%
|
| Week 8: >=90% Reduction |
4.2
1.5%
|
4.2
1.5%
|
6.4
2.3%
|
8.4
2.9%
|
2.1
0.7%
|
5.9
2.3%
|
7.1
2.8%
|
6.3
2.5%
|
7.5
3%
|
2.7
1.1%
|
| Week 12: >=30% Reduction |
49.8
17.5%
|
50.9
17.7%
|
59.3
21.2%
|
60.7
21.1%
|
36.9
13%
|
52.8
20.6%
|
57.1
22.5%
|
57.3
22.4%
|
60.2
23.7%
|
37.6
14.7%
|
| Week 12: >=50% Reduction |
32.6
11.4%
|
35.5
12.3%
|
34.3
12.3%
|
43.5
15.1%
|
21.3
7.5%
|
36.6
14.3%
|
37.8
14.9%
|
39.2
15.3%
|
42.9
16.9%
|
22.0
8.6%
|
| Week 12: >=70% Reduction |
15.4
5.4%
|
16.4
5.7%
|
19.6
7%
|
26.0
9%
|
8.5
3%
|
20.5
8%
|
20.9
8.2%
|
21.6
8.4%
|
24.0
9.4%
|
9.0
3.5%
|
| Week 12: >=90% Reduction |
6.3
2.2%
|
6.6
2.3%
|
7.1
2.5%
|
10.5
3.6%
|
2.8
1%
|
5.1
2%
|
8.7
3.4%
|
7.1
2.8%
|
11.0
4.3%
|
2.4
0.9%
|
| Week 16: >=30% Reduction |
49.1
17.2%
|
52.3
18.2%
|
56.8
20.3%
|
61.8
21.5%
|
39.7
14%
|
52.4
20.5%
|
53.9
21.2%
|
56.9
22.2%
|
57.1
22.5%
|
41.6
16.3%
|
| Week 16: >=50% Reduction |
30.2
10.6%
|
35.9
12.5%
|
37.5
13.4%
|
41.8
14.5%
|
21.6
7.6%
|
38.2
14.9%
|
36.6
14.4%
|
39.2
15.3%
|
43.7
17.2%
|
25.5
10%
|
| Week 16: >=70% Reduction |
16.1
5.6%
|
18.1
6.3%
|
16.8
6%
|
27.4
9.5%
|
8.5
3%
|
20.9
8.2%
|
19.7
7.8%
|
22.7
8.9%
|
24.8
9.8%
|
9.8
3.8%
|
| Week 16: >=90% Reduction |
6.0
2.1%
|
6.6
2.3%
|
7.5
2.7%
|
9.1
3.2%
|
2.5
0.9%
|
7.9
3.1%
|
6.7
2.6%
|
7.8
3%
|
12.6
5%
|
2.7
1.1%
|
| Week 24: >=30% Reduction |
49.5
17.4%
|
53.0
18.4%
|
54.3
19.4%
|
55.8
19.4%
|
42.9
15.2%
|
49.2
19.2%
|
53.9
21.2%
|
52.5
20.5%
|
57.9
22.8%
|
45.5
17.8%
|
| Week 24: >=50% Reduction |
34.0
11.9%
|
36.2
12.6%
|
33.2
11.9%
|
40.7
14.1%
|
25.2
8.9%
|
34.3
13.4%
|
35.4
13.9%
|
37.6
14.7%
|
43.3
17%
|
27.8
10.9%
|
| Week 24: >=70% Reduction |
16.8
5.9%
|
18.5
6.4%
|
19.6
7%
|
24.6
8.5%
|
13.1
4.6%
|
16.5
6.4%
|
20.5
8.1%
|
22.7
8.9%
|
24.0
9.4%
|
11.4
4.5%
|
| Week 24: >=90% Reduction |
7.4
2.6%
|
7.7
2.7%
|
7.5
2.7%
|
7.4
2.6%
|
4.3
1.5%
|
7.9
3.1%
|
7.9
3.1%
|
7.8
3%
|
11.8
4.6%
|
3.9
1.5%
|
| Week 32: >=30% Reduction |
49.5
17.4%
|
52.3
18.2%
|
53.6
19.1%
|
56.5
19.6%
|
44.3
15.7%
|
49.6
19.4%
|
51.6
20.3%
|
52.5
20.5%
|
53.5
21.1%
|
43.1
16.8%
|
| Week 32: >=50% Reduction |
30.2
10.6%
|
33.8
11.7%
|
33.9
12.1%
|
42.5
14.8%
|
27.3
9.6%
|
35.4
13.8%
|
36.2
14.3%
|
39.2
15.3%
|
39.4
15.5%
|
28.2
11%
|
| Week 32: >=70% Reduction |
18.2
6.4%
|
17.8
6.2%
|
16.1
5.8%
|
22.1
7.7%
|
12.1
4.3%
|
19.3
7.5%
|
21.7
8.5%
|
21.6
8.4%
|
22.0
8.7%
|
12.5
4.9%
|
| Week 32: >=90% Reduction |
5.6
2%
|
7.0
2.4%
|
5.4
1.9%
|
8.4
2.9%
|
5.0
1.8%
|
7.9
3.1%
|
9.1
3.6%
|
10.6
4.1%
|
12.6
5%
|
2.4
0.9%
|
| Week 40: >=30% Reduction |
49.5
17.4%
|
50.9
17.7%
|
51.8
18.5%
|
52.6
18.3%
|
42.2
14.9%
|
49.2
19.2%
|
50.8
20%
|
49.8
19.5%
|
53.9
21.2%
|
41.6
16.3%
|
| Week 40: >=50% Reduction |
31.9
11.2%
|
31.7
11%
|
30.4
10.9%
|
38.2
13.3%
|
25.5
9%
|
34.3
13.4%
|
31.1
12.2%
|
33.3
13%
|
39.0
15.4%
|
29.0
11.3%
|
| Week 40: >=70% Reduction |
16.1
5.6%
|
17.4
6%
|
15.7
5.6%
|
19.3
6.7%
|
9.2
3.3%
|
17.7
6.9%
|
20.5
8.1%
|
19.6
7.7%
|
21.7
8.5%
|
11.4
4.5%
|
| Week 40: >=90% Reduction |
5.3
1.9%
|
5.6
1.9%
|
4.6
1.6%
|
5.6
1.9%
|
3.2
1.1%
|
7.5
2.9%
|
5.9
2.3%
|
8.6
3.4%
|
9.4
3.7%
|
2.4
0.9%
|
| Week 48: >=30% Reduction |
48.8
17.1%
|
51.6
17.9%
|
51.4
18.4%
|
51.9
18%
|
40.4
14.3%
|
48.4
18.9%
|
49.2
19.4%
|
50.2
19.6%
|
51.2
20.2%
|
42.0
16.4%
|
| Week 48: >=50% Reduction |
30.9
10.8%
|
30.7
10.7%
|
30.4
10.9%
|
36.5
12.7%
|
23.4
8.3%
|
30.7
12%
|
31.9
12.6%
|
33.7
13.2%
|
37.0
14.6%
|
27.1
10.6%
|
| Week 48: >=70% Reduction |
17.2
6%
|
16.0
5.6%
|
15.4
5.5%
|
18.9
6.6%
|
11.0
3.9%
|
16.1
6.3%
|
18.9
7.4%
|
20.4
8%
|
20.5
8.1%
|
11.8
4.6%
|
| Week 48: >=90% Reduction |
5.6
2%
|
5.9
2%
|
4.6
1.6%
|
6.7
2.3%
|
3.9
1.4%
|
5.9
2.3%
|
5.5
2.2%
|
7.5
2.9%
|
9.4
3.7%
|
2.7
1.1%
|
| Week 56: >=30% Reduction |
47.7
16.7%
|
50.2
17.4%
|
51.4
18.4%
|
52.6
18.3%
|
40.4
14.3%
|
46.9
18.3%
|
46.5
18.3%
|
47.8
18.7%
|
52.0
20.5%
|
41.6
16.3%
|
| Week 56: >=50% Reduction |
30.2
10.6%
|
28.9
10%
|
28.6
10.2%
|
36.1
12.5%
|
22.7
8%
|
29.9
11.7%
|
28.7
11.3%
|
31.8
12.4%
|
37.8
14.9%
|
27.5
10.7%
|
| Week 56: >=70% Reduction |
16.5
5.8%
|
15.3
5.3%
|
16.1
5.8%
|
17.9
6.2%
|
9.9
3.5%
|
14.2
5.5%
|
16.5
6.5%
|
18.4
7.2%
|
20.5
8.1%
|
12.5
4.9%
|
| Week 56: >=90% Reduction |
6.0
2.1%
|
5.2
1.8%
|
4.6
1.6%
|
6.3
2.2%
|
3.2
1.1%
|
5.1
2%
|
4.7
1.9%
|
7.5
2.9%
|
8.7
3.4%
|
2.4
0.9%
|
| Title | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 285 | 282 | 254 | 254 | 255 | 254 | 255 |
| >0% |
198
69.5%
|
201
69.8%
|
199
71.1%
|
203
70.5%
|
172
60.8%
|
177
69.1%
|
182
71.7%
|
193
75.4%
|
194
76.4%
|
170
66.4%
|
| >=10% |
179
62.8%
|
184
63.9%
|
183
65.4%
|
194
67.4%
|
153
54.1%
|
162
63.3%
|
167
65.7%
|
176
68.8%
|
184
72.4%
|
150
58.6%
|
| >=20% |
148
51.9%
|
162
56.3%
|
158
56.4%
|
174
60.4%
|
130
45.9%
|
142
55.5%
|
150
59.1%
|
151
59%
|
162
63.8%
|
124
48.4%
|
| >=30% |
127
44.6%
|
135
46.9%
|
139
49.6%
|
154
53.5%
|
102
36%
|
122
47.7%
|
124
48.8%
|
135
52.7%
|
138
54.3%
|
100
39.1%
|
| >=40% |
103
36.1%
|
117
40.6%
|
118
42.1%
|
132
45.8%
|
81
28.6%
|
108
42.2%
|
114
44.9%
|
115
44.9%
|
123
48.4%
|
81
31.6%
|
| >=50% |
78
27.4%
|
94
32.6%
|
96
34.3%
|
104
36.1%
|
56
19.8%
|
89
34.8%
|
89
35%
|
96
37.5%
|
108
42.5%
|
62
24.2%
|
| >=60% |
53
18.6%
|
75
26%
|
61
21.8%
|
82
28.5%
|
39
13.8%
|
70
27.3%
|
68
26.8%
|
72
28.1%
|
79
31.1%
|
44
17.2%
|
| >=70% |
43
15.1%
|
50
17.4%
|
42
15%
|
71
24.7%
|
22
7.8%
|
51
19.9%
|
46
18.1%
|
56
21.9%
|
63
24.8%
|
25
9.8%
|
| >=80% |
29
10.2%
|
29
10.1%
|
31
11.1%
|
45
15.6%
|
14
4.9%
|
31
12.1%
|
34
13.4%
|
36
14.1%
|
50
19.7%
|
13
5.1%
|
| >=90% |
17
6%
|
18
6.3%
|
19
6.8%
|
24
8.3%
|
7
2.5%
|
19
7.4%
|
15
5.9%
|
20
7.8%
|
32
12.6%
|
7
2.7%
|
| 100% |
4
1.4%
|
11
3.8%
|
12
4.3%
|
10
3.5%
|
3
1.1%
|
5
2%
|
8
3.1%
|
7
2.7%
|
11
4.3%
|
5
2%
|
| Title | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| >0% |
228
80%
|
234
81.3%
|
233
83.2%
|
245
85.1%
|
201
71%
|
197
77%
|
202
79.5%
|
208
81.3%
|
208
81.9%
|
188
73.4%
|
| >=10% |
203
71.2%
|
210
72.9%
|
215
76.8%
|
229
79.5%
|
175
61.8%
|
179
69.9%
|
184
72.4%
|
188
73.4%
|
197
77.6%
|
162
63.3%
|
| >=20% |
167
58.6%
|
183
63.5%
|
181
64.6%
|
201
69.8%
|
144
50.9%
|
157
61.3%
|
167
65.7%
|
163
63.7%
|
173
68.1%
|
134
52.3%
|
| >=30% |
140
49.1%
|
150
52.1%
|
159
56.8%
|
176
61.1%
|
112
39.6%
|
133
52%
|
137
53.9%
|
145
56.6%
|
145
57.1%
|
106
41.4%
|
| >=40% |
114
40%
|
129
44.8%
|
132
47.1%
|
150
52.1%
|
88
31.1%
|
117
45.7%
|
120
47.2%
|
120
46.9%
|
127
50%
|
84
32.8%
|
| >=50% |
86
30.2%
|
103
35.8%
|
105
37.5%
|
119
41.3%
|
61
21.6%
|
97
37.9%
|
93
36.6%
|
100
39.1%
|
111
43.7%
|
65
25.4%
|
| >=60% |
58
20.4%
|
79
27.4%
|
68
24.3%
|
92
31.9%
|
43
15.2%
|
77
30.1%
|
72
28.3%
|
75
29.3%
|
80
31.5%
|
45
17.6%
|
| >=70% |
46
16.1%
|
52
18.1%
|
47
16.8%
|
78
27.1%
|
24
8.5%
|
53
20.7%
|
50
19.7%
|
58
22.7%
|
63
24.8%
|
25
9.8%
|
| >=80% |
31
10.9%
|
30
10.4%
|
36
12.9%
|
48
16.7%
|
16
5.7%
|
32
12.5%
|
38
15%
|
37
14.5%
|
50
19.7%
|
13
5.1%
|
| >=90% |
17
6%
|
19
6.6%
|
21
7.5%
|
26
9%
|
7
2.5%
|
20
7.8%
|
17
6.7%
|
20
7.8%
|
32
12.6%
|
7
2.7%
|
| 100% |
4
1.4%
|
12
4.2%
|
14
5%
|
12
4.2%
|
3
1.1%
|
5
2%
|
8
3.1%
|
7
2.7%
|
11
4.3%
|
5
2%
|
| Title | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported. |
| Time Frame | Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2 |
9.9
3.5%
|
10.1
3.5%
|
8.2
2.9%
|
10.9
3.8%
|
6.4
2.3%
|
11.3
4.4%
|
9.4
3.7%
|
12.5
4.9%
|
5.9
2.3%
|
6.3
2.5%
|
| Week 4 |
10.2
3.6%
|
13.5
4.7%
|
17.5
6.3%
|
15.1
5.2%
|
10.6
3.7%
|
19.1
7.5%
|
18.5
7.3%
|
18.8
7.3%
|
14.6
5.7%
|
10.6
4.1%
|
| Week 8 |
14.1
4.9%
|
18.4
6.4%
|
18.2
6.5%
|
19.3
6.7%
|
9.2
3.3%
|
15.6
6.1%
|
16.5
6.5%
|
19.6
7.7%
|
17.4
6.9%
|
11.8
4.6%
|
| Week 12 |
15.5
5.4%
|
17.4
6%
|
18.2
6.5%
|
25.3
8.8%
|
12.7
4.5%
|
17.2
6.7%
|
17.7
7%
|
20.8
8.1%
|
22.1
8.7%
|
12.2
4.8%
|
| Week 16 |
14.8
5.2%
|
19.1
6.6%
|
16.4
5.9%
|
22.5
7.8%
|
10.6
3.7%
|
18.4
7.2%
|
15.4
6.1%
|
20.0
7.8%
|
18.2
7.2%
|
13.4
5.2%
|
| Week 24 |
17.6
6.2%
|
18.1
6.3%
|
12.1
4.3%
|
18.6
6.5%
|
14.1
5%
|
13.3
5.2%
|
12.6
5%
|
18.8
7.3%
|
20.9
8.2%
|
13.0
5.1%
|
| Title | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported. |
| Time Frame | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Week 2 |
9.9
3.5%
|
10.1
3.5%
|
8.2
2.9%
|
10.9
3.8%
|
6.4
2.3%
|
11.3
4.4%
|
9.4
3.7%
|
12.5
4.9%
|
5.9
2.3%
|
6.3
2.5%
|
| Week 4 |
10.6
3.7%
|
14.2
4.9%
|
17.9
6.4%
|
16.1
5.6%
|
10.6
3.7%
|
20.3
7.9%
|
18.9
7.4%
|
18.8
7.3%
|
14.6
5.7%
|
11.0
4.3%
|
| Week 8 |
15.1
5.3%
|
20.5
7.1%
|
19.3
6.9%
|
20.7
7.2%
|
9.9
3.5%
|
17.2
6.7%
|
18.5
7.3%
|
19.6
7.7%
|
18.2
7.2%
|
13.0
5.1%
|
| Week 12 |
16.9
5.9%
|
20.8
7.2%
|
20.4
7.3%
|
27.0
9.4%
|
13.8
4.9%
|
19.1
7.5%
|
20.9
8.2%
|
21.6
8.4%
|
23.3
9.2%
|
13.4
5.2%
|
| Week 16 |
16.5
5.8%
|
22.6
7.8%
|
18.9
6.8%
|
24.2
8.4%
|
12.0
4.2%
|
21.1
8.2%
|
18.1
7.1%
|
20.8
8.1%
|
19.4
7.6%
|
14.6
5.7%
|
| Week 24 |
20.1
7.1%
|
22.2
7.7%
|
15.4
5.5%
|
21.4
7.4%
|
16.3
5.8%
|
16.8
6.6%
|
15.4
6.1%
|
20.4
8%
|
22.5
8.9%
|
15.0
5.9%
|
| Week 32 |
14.4
5.1%
|
18.8
6.5%
|
16.4
5.9%
|
23.2
8.1%
|
15.5
5.5%
|
19.1
7.5%
|
16.5
6.5%
|
19.2
7.5%
|
20.2
8%
|
15.0
5.9%
|
| Week 40 |
14.8
5.2%
|
17.4
6%
|
13.9
5%
|
18.9
6.6%
|
14.1
5%
|
18.4
7.2%
|
15.0
5.9%
|
18.4
7.2%
|
20.6
8.1%
|
15.4
6%
|
| Week 48 |
14.4
5.1%
|
16.7
5.8%
|
12.9
4.6%
|
16.1
5.6%
|
14.5
5.1%
|
17.2
6.7%
|
14.6
5.7%
|
18.8
7.3%
|
17.4
6.9%
|
14.6
5.7%
|
| Week 56 |
14.4
5.1%
|
15.3
5.3%
|
13.6
4.9%
|
15.8
5.5%
|
13.4
4.7%
|
14.8
5.8%
|
11.8
4.6%
|
18.4
7.2%
|
17.8
7%
|
15.0
5.9%
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 287 | 280 | 286 | 281 | 255 | 254 | 255 | 254 | 255 |
| Baseline |
6.50
(2.00)
|
6.66
(1.85)
|
6.70
(1.88)
|
6.42
(2.05)
|
6.60
(1.73)
|
6.62
(2.14)
|
6.58
(2.04)
|
6.47
(2.14)
|
6.33
(2.01)
|
6.39
(1.89)
|
| Change at Week 2 |
-1.35
(2.43)
|
-1.32
(2.18)
|
-1.65
(2.44)
|
-1.19
(2.29)
|
-1.02
(1.98)
|
-1.35
(2.52)
|
-1.21
(2.40)
|
-1.41
(2.31)
|
-1.11
(2.44)
|
-0.82
(2.04)
|
| Change at Week 4 |
-1.85
(2.46)
|
-2.10
(2.34)
|
-2.31
(2.51)
|
-2.19
(2.44)
|
-1.23
(2.17)
|
-1.94
(2.65)
|
-2.05
(2.49)
|
-2.15
(2.48)
|
-2.25
(2.43)
|
-1.00
(2.18)
|
| Change at Week 8 |
-1.76
(2.60)
|
-2.26
(2.38)
|
-2.26
(2.66)
|
-2.31
(2.54)
|
-1.29
(2.24)
|
-2.02
(2.66)
|
-2.22
(2.59)
|
-2.28
(2.51)
|
-2.60
(2.51)
|
-1.13
(2.16)
|
| Change at Week 12 |
-1.98
(2.64)
|
-2.14
(2.38)
|
-2.49
(2.52)
|
-2.42
(2.69)
|
-1.40
(2.27)
|
-2.38
(2.75)
|
-2.36
(2.87)
|
-2.42
(2.70)
|
-2.72
(2.54)
|
-1.23
(2.16)
|
| Change at Week 16 |
-1.93
(2.55)
|
-2.15
(2.40)
|
-2.31
(2.57)
|
-2.40
(2.65)
|
-1.42
(2.22)
|
-2.14
(2.74)
|
-2.28
(2.68)
|
-2.35
(2.62)
|
-2.62
(2.64)
|
-1.34
(2.13)
|
| Change at Week 24 |
-1.80
(2.62)
|
-1.96
(2.52)
|
-1.98
(2.57)
|
-2.04
(2.74)
|
-1.46
(2.28)
|
-1.97
(2.56)
|
-2.10
(2.64)
|
-2.08
(2.59)
|
-2.39
(2.59)
|
-1.38
(2.18)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 284 | 287 | 280 | 286 | 281 | 255 | 254 | 255 | 254 | 255 |
| Change at Week 2 |
-1.35
(2.43)
|
-1.32
(2.18)
|
-1.65
(2.44)
|
-1.19
(2.29)
|
-1.02
(1.98)
|
-1.35
(2.52)
|
-1.21
(2.40)
|
-1.41
(2.31)
|
-1.11
(2.44)
|
-0.82
(2.04)
|
| Change at Week 4 |
-1.88
(2.49)
|
-2.17
(2.33)
|
-2.34
(2.50)
|
-2.27
(2.46)
|
-1.26
(2.20)
|
-2.04
(2.71)
|
-2.03
(2.52)
|
-2.13
(2.53)
|
-2.22
(2.49)
|
-1.01
(2.18)
|
| Change at Week 8 |
-1.88
(2.67)
|
-2.43
(2.38)
|
-2.44
(2.66)
|
-2.52
(2.53)
|
-1.35
(2.32)
|
-2.15
(2.75)
|
-2.30
(2.62)
|
-2.30
(2.62)
|
-2.58
(2.60)
|
-1.15
(2.18)
|
| Change at Week 12 |
-2.18
(2.71)
|
-2.39
(2.38)
|
-2.71
(2.50)
|
-2.68
(2.69)
|
-1.52
(2.40)
|
-2.55
(2.92)
|
-2.49
(2.90)
|
-2.49
(2.79)
|
-2.76
(2.64)
|
-1.24
(2.23)
|
| Change at Week 16 |
-2.16
(2.62)
|
-2.44
(2.38)
|
-2.64
(2.58)
|
-2.70
(2.67)
|
-1.58
(2.35)
|
-2.35
(2.91)
|
-2.41
(2.71)
|
-2.43
(2.77)
|
-2.68
(2.72)
|
-1.38
(2.25)
|
| Change at Week 24 |
-2.22
(2.75)
|
-2.36
(2.50)
|
-2.48
(2.65)
|
-2.46
(2.81)
|
-1.75
(2.45)
|
-2.28
(2.78)
|
-2.37
(2.66)
|
-2.23
(2.78)
|
-2.55
(2.68)
|
-1.43
(2.33)
|
| Change at Week 32 |
-2.07
(2.86)
|
-2.23
(2.51)
|
-2.36
(2.62)
|
-2.48
(2.80)
|
-1.80
(2.52)
|
-2.18
(2.79)
|
-2.31
(2.73)
|
-2.46
(2.79)
|
-2.31
(2.68)
|
-1.41
(2.37)
|
| Change at Week 40 |
-2.05
(2.85)
|
-2.15
(2.63)
|
-2.13
(2.63)
|
-2.24
(2.76)
|
-1.69
(2.52)
|
-2.10
(2.83)
|
-2.20
(2.74)
|
-2.16
(2.74)
|
-2.26
(2.68)
|
-1.43
(2.47)
|
| Change at Week 48 |
-2.03
(2.90)
|
-2.23
(2.71)
|
-2.11
(2.71)
|
-2.20
(2.71)
|
-1.69
(2.54)
|
-2.01
(2.80)
|
-2.10
(2.73)
|
-2.22
(2.80)
|
-2.17
(2.67)
|
-1.34
(2.45)
|
| Change at Week 56 |
-1.99
(2.86)
|
-2.10
(2.66)
|
-2.07
(2.72)
|
-2.08
(2.74)
|
-1.63
(2.49)
|
-1.97
(2.80)
|
-1.94
(2.72)
|
-2.10
(2.76)
|
-2.14
(2.69)
|
-1.34
(2.47)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 286 | 283 | 255 | 254 | 256 | 254 | 255 |
| Baseline |
6.45
(1.62)
|
6.54
(1.53)
|
6.60
(1.58)
|
6.38
(1.63)
|
6.41
(1.51)
|
6.60
(1.58)
|
6.54
(1.54)
|
6.48
(1.70)
|
6.33
(1.59)
|
6.38
(1.55)
|
| Change at Week 2 |
-1.13
(1.90)
|
-1.15
(1.86)
|
-1.46
(2.03)
|
-1.04
(2.03)
|
-0.93
(1.69)
|
-1.17
(2.05)
|
-0.98
(2.01)
|
-1.23
(1.94)
|
-0.99
(2.12)
|
-0.89
(1.65)
|
| Change at Week 4 |
-1.74
(2.04)
|
-1.92
(1.91)
|
-2.15
(2.15)
|
-2.06
(2.11)
|
-1.13
(1.91)
|
-1.79
(2.30)
|
-1.87
(2.07)
|
-2.08
(2.20)
|
-2.10
(2.17)
|
-1.06
(1.85)
|
| Change at Week 8 |
-1.68
(2.21)
|
-2.11
(2.05)
|
-2.14
(2.27)
|
-2.22
(2.20)
|
-1.15
(1.94)
|
-1.93
(2.30)
|
-2.08
(2.22)
|
-2.23
(2.19)
|
-2.42
(2.25)
|
-1.14
(1.91)
|
| Change at Week 12 |
-1.90
(2.26)
|
-1.98
(2.08)
|
-2.31
(2.18)
|
-2.35
(2.33)
|
-1.27
(2.02)
|
-2.26
(2.40)
|
-2.24
(2.52)
|
-2.35
(2.36)
|
-2.55
(2.30)
|
-1.33
(1.89)
|
| Change at Week 16 |
-1.84
(2.17)
|
-1.98
(2.17)
|
-2.17
(2.19)
|
-2.28
(2.29)
|
-1.34
(1.99)
|
-2.13
(2.39)
|
-2.17
(2.35)
|
-2.30
(2.36)
|
-2.48
(2.42)
|
-1.42
(1.94)
|
| Change at Week 24 |
-1.70
(2.29)
|
-1.84
(2.19)
|
-1.87
(2.17)
|
-1.99
(2.38)
|
-1.34
(2.06)
|
-1.90
(2.28)
|
-2.05
(2.31)
|
-2.09
(2.35)
|
-2.33
(2.42)
|
-1.53
(2.00)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 286 | 283 | 255 | 254 | 256 | 254 | 255 |
| Change at Week 2 |
-1.13
(1.90)
|
-1.15
(1.86)
|
-1.46
(2.03)
|
-1.04
(2.03)
|
-0.93
(1.69)
|
-1.17
(2.05)
|
-0.98
(2.01)
|
-1.23
(1.94)
|
-0.99
(2.12)
|
-0.89
(1.65)
|
| Change at Week 4 |
-1.74
(2.06)
|
-1.98
(1.90)
|
-2.18
(2.13)
|
-2.13
(2.13)
|
-1.15
(1.95)
|
-1.87
(2.36)
|
-1.84
(2.12)
|
-2.06
(2.26)
|
-2.07
(2.23)
|
-1.07
(1.85)
|
| Change at Week 8 |
-1.78
(2.26)
|
-2.25
(2.05)
|
-2.31
(2.26)
|
-2.41
(2.19)
|
-1.20
(2.01)
|
-2.03
(2.39)
|
-2.15
(2.25)
|
-2.22
(2.29)
|
-2.41
(2.34)
|
-1.16
(1.94)
|
| Change at Week 12 |
-2.08
(2.31)
|
-2.20
(2.09)
|
-2.52
(2.14)
|
-2.58
(2.32)
|
-1.37
(2.14)
|
-2.40
(2.52)
|
-2.37
(2.55)
|
-2.40
(2.44)
|
-2.59
(2.39)
|
-1.33
(1.97)
|
| Change at Week 16 |
-2.05
(2.22)
|
-2.24
(2.16)
|
-2.48
(2.17)
|
-2.57
(2.27)
|
-1.45
(2.10)
|
-2.31
(2.51)
|
-2.29
(2.38)
|
-2.36
(2.46)
|
-2.53
(2.48)
|
-1.45
(2.03)
|
| Change at Week 24 |
-2.10
(2.37)
|
-2.18
(2.19)
|
-2.30
(2.22)
|
-2.36
(2.40)
|
-1.58
(2.24)
|
-2.16
(2.41)
|
-2.28
(2.33)
|
-2.22
(2.45)
|
-2.46
(2.49)
|
-1.58
(2.13)
|
| Change at Week 32 |
-1.96
(2.44)
|
-2.10
(2.24)
|
-2.20
(2.26)
|
-2.35
(2.42)
|
-1.64
(2.29)
|
-2.10
(2.44)
|
-2.20
(2.44)
|
-2.30
(2.51)
|
-2.22
(2.52)
|
-1.53
(2.15)
|
| Change at Week 40 |
-1.94
(2.43)
|
-1.99
(2.35)
|
-1.99
(2.31)
|
-2.14
(2.40)
|
-1.51
(2.26)
|
-2.05
(2.43)
|
-2.07
(2.39)
|
-2.05
(2.50)
|
-2.20
(2.48)
|
-1.49
(2.16)
|
| Change at Week 48 |
-1.91
(2.44)
|
-2.02
(2.39)
|
-1.96
(2.36)
|
-2.08
(2.33)
|
-1.48
(2.28)
|
-1.94
(2.40)
|
-2.00
(2.40)
|
-2.10
(2.50)
|
-2.08
(2.48)
|
-1.40
(2.16)
|
| Change at Week 56 |
-1.89
(2.43)
|
-1.93
(2.36)
|
-1.93
(2.36)
|
-1.99
(2.32)
|
-1.43
(2.25)
|
-1.90
(2.33)
|
-1.81
(2.36)
|
-1.98
(2.46)
|
-2.07
(2.48)
|
-1.42
(2.18)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Baseline |
6.22
(1.83)
|
6.37
(1.97)
|
6.34
(1.87)
|
6.13
(1.96)
|
6.12
(2.08)
|
6.28
(1.83)
|
6.30
(1.88)
|
6.21
(1.97)
|
6.14
(1.97)
|
6.10
(1.83)
|
| Change at Week 2 |
-1.05
(2.24)
|
-1.02
(2.43)
|
-1.31
(2.24)
|
-0.87
(2.43)
|
-0.80
(2.08)
|
-1.04
(2.34)
|
-0.68
(2.49)
|
-1.01
(2.24)
|
-0.86
(2.51)
|
-0.86
(2.04)
|
| Change at Week 4 |
-1.67
(2.37)
|
-1.88
(2.39)
|
-1.98
(2.19)
|
-1.92
(2.34)
|
-1.04
(2.47)
|
-1.49
(2.58)
|
-1.64
(2.44)
|
-1.88
(2.53)
|
-1.93
(2.45)
|
-0.95
(2.27)
|
| Change at Week 8 |
-1.57
(2.64)
|
-1.95
(2.51)
|
-1.93
(2.53)
|
-2.09
(2.50)
|
-1.05
(2.33)
|
-1.67
(2.50)
|
-1.84
(2.50)
|
-2.11
(2.44)
|
-2.26
(2.58)
|
-1.11
(2.40)
|
| Change at Week 12 |
-1.74
(2.53)
|
-1.78
(2.38)
|
-2.15
(2.38)
|
-2.22
(2.51)
|
-1.10
(2.34)
|
-2.04
(2.54)
|
-2.02
(2.84)
|
-2.20
(2.73)
|
-2.25
(2.61)
|
-1.35
(2.24)
|
| Change at Week 16 |
-1.71
(2.40)
|
-1.77
(2.61)
|
-1.95
(2.49)
|
-2.19
(2.49)
|
-1.23
(2.32)
|
-1.94
(2.69)
|
-1.91
(2.66)
|
-2.08
(2.75)
|
-2.22
(2.69)
|
-1.38
(2.28)
|
| Change at Week 24 |
-1.56
(2.49)
|
-1.65
(2.47)
|
-1.64
(2.47)
|
-1.83
(2.51)
|
-1.20
(2.33)
|
-1.63
(2.61)
|
-1.88
(2.65)
|
-1.96
(2.71)
|
-2.06
(2.72)
|
-1.55
(2.33)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Change at Week 2 |
-1.05
(2.24)
|
-1.02
(2.43)
|
-1.31
(2.24)
|
-0.87
(2.43)
|
-0.80
(2.08)
|
-1.04
(2.34)
|
-0.68
(2.49)
|
-1.01
(2.24)
|
-0.86
(2.51)
|
-0.86
(2.04)
|
| Change at Week 4 |
-1.65
(2.40)
|
-1.92
(2.41)
|
-2.01
(2.18)
|
-1.99
(2.36)
|
-1.04
(2.51)
|
-1.54
(2.65)
|
-1.59
(2.51)
|
-1.84
(2.62)
|
-1.91
(2.51)
|
-0.96
(2.28)
|
| Change at Week 8 |
-1.65
(2.69)
|
-2.09
(2.62)
|
-2.08
(2.53)
|
-2.26
(2.52)
|
-1.07
(2.45)
|
-1.73
(2.64)
|
-1.85
(2.62)
|
-2.06
(2.60)
|
-2.22
(2.71)
|
-1.13
(2.45)
|
| Change at Week 12 |
-1.93
(2.62)
|
-1.98
(2.53)
|
-2.32
(2.38)
|
-2.41
(2.57)
|
-1.20
(2.54)
|
-2.11
(2.71)
|
-2.08
(2.97)
|
-2.20
(2.86)
|
-2.27
(2.76)
|
-1.36
(2.33)
|
| Change at Week 16 |
-1.93
(2.50)
|
-2.00
(2.74)
|
-2.20
(2.55)
|
-2.44
(2.51)
|
-1.33
(2.52)
|
-2.03
(2.85)
|
-1.98
(2.81)
|
-2.11
(2.91)
|
-2.25
(2.83)
|
-1.42
(2.41)
|
| Change at Week 24 |
-1.95
(2.64)
|
-1.94
(2.68)
|
-1.98
(2.61)
|
-2.15
(2.59)
|
-1.36
(2.62)
|
-1.79
(2.79)
|
-1.97
(2.86)
|
-2.04
(2.89)
|
-2.15
(2.87)
|
-1.64
(2.52)
|
| Change at Week 32 |
-1.78
(2.72)
|
-1.80
(2.85)
|
-1.91
(2.61)
|
-2.12
(2.67)
|
-1.45
(2.71)
|
-1.78
(2.87)
|
-1.80
(2.99)
|
-1.96
(2.89)
|
-1.89
(3.00)
|
-1.56
(2.48)
|
| Change at Week 40 |
-1.69
(2.76)
|
-1.78
(2.92)
|
-1.69
(2.69)
|
-1.77
(2.71)
|
-1.23
(2.66)
|
-1.72
(2.75)
|
-1.75
(2.84)
|
-1.73
(2.92)
|
-1.89
(2.95)
|
-1.40
(2.53)
|
| Change at Week 48 |
-1.63
(2.81)
|
-1.72
(2.92)
|
-1.68
(2.76)
|
-1.78
(2.64)
|
-1.22
(2.67)
|
-1.62
(2.72)
|
-1.64
(2.92)
|
-1.79
(2.90)
|
-1.74
(2.98)
|
-1.33
(2.60)
|
| Change at Week 56 |
-1.65
(2.79)
|
-1.64
(2.92)
|
-1.68
(2.76)
|
-1.73
(2.63)
|
-1.15
(2.62)
|
-1.61
(2.62)
|
-1.42
(2.89)
|
-1.67
(2.92)
|
-1.72
(2.94)
|
-1.36
(2.63)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Baseline |
7.55
(1.80)
|
7.68
(1.78)
|
7.72
(1.69)
|
7.50
(1.73)
|
7.40
(1.87)
|
7.80
(1.71)
|
7.59
(1.77)
|
7.55
(1.77)
|
7.54
(1.78)
|
7.52
(1.70)
|
| Change at Week 2 |
-1.29
(2.23)
|
-1.34
(2.33)
|
-1.67
(2.39)
|
-1.36
(2.42)
|
-0.94
(2.19)
|
-1.41
(2.39)
|
-1.23
(2.31)
|
-1.45
(2.43)
|
-1.37
(2.18)
|
-1.05
(2.08)
|
| Change at Week 4 |
-1.78
(2.31)
|
-2.13
(2.30)
|
-2.46
(2.55)
|
-2.32
(2.44)
|
-1.22
(2.38)
|
-2.05
(2.65)
|
-2.07
(2.35)
|
-2.43
(2.63)
|
-2.36
(2.43)
|
-1.29
(2.21)
|
| Change at Week 8 |
-1.79
(2.50)
|
-2.32
(2.49)
|
-2.41
(2.62)
|
-2.53
(2.60)
|
-1.34
(2.27)
|
-2.17
(2.63)
|
-2.26
(2.58)
|
-2.48
(2.56)
|
-2.65
(2.59)
|
-1.33
(2.04)
|
| Change at Week 12 |
-2.09
(2.69)
|
-2.16
(2.59)
|
-2.49
(2.57)
|
-2.67
(2.66)
|
-1.37
(2.37)
|
-2.45
(2.71)
|
-2.52
(2.78)
|
-2.48
(2.72)
|
-2.79
(2.64)
|
-1.50
(2.10)
|
| Change at Week 16 |
-1.99
(2.60)
|
-2.20
(2.65)
|
-2.35
(2.47)
|
-2.53
(2.64)
|
-1.53
(2.29)
|
-2.39
(2.71)
|
-2.35
(2.68)
|
-2.52
(2.76)
|
-2.76
(2.77)
|
-1.66
(2.17)
|
| Change at Week 24 |
-1.82
(2.66)
|
-2.01
(2.67)
|
-2.02
(2.52)
|
-2.22
(2.74)
|
-1.51
(2.28)
|
-2.02
(2.74)
|
-2.28
(2.63)
|
-2.47
(2.90)
|
-2.63
(2.76)
|
-1.73
(2.33)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 287 | 280 | 286 | 282 | 254 | 254 | 256 | 254 | 255 |
| Change at Week 2 |
-1.29
(2.23)
|
-1.34
(2.33)
|
-1.67
(2.39)
|
-1.36
(2.42)
|
-0.94
(2.19)
|
-1.41
(2.39)
|
-1.23
(2.31)
|
-1.45
(2.43)
|
-1.37
(2.18)
|
-1.05
(2.08)
|
| Change at Week 4 |
-1.80
(2.31)
|
-2.20
(2.31)
|
-2.51
(2.55)
|
-2.41
(2.44)
|
-1.26
(2.39)
|
-2.14
(2.68)
|
-2.05
(2.39)
|
-2.43
(2.70)
|
-2.37
(2.44)
|
-1.30
(2.20)
|
| Change at Week 8 |
-1.90
(2.55)
|
-2.48
(2.52)
|
-2.62
(2.61)
|
-2.75
(2.59)
|
-1.35
(2.37)
|
-2.27
(2.68)
|
-2.37
(2.61)
|
-2.50
(2.67)
|
-2.71
(2.60)
|
-1.35
(2.08)
|
| Change at Week 12 |
-2.29
(2.70)
|
-2.40
(2.60)
|
-2.76
(2.52)
|
-2.94
(2.65)
|
-1.47
(2.52)
|
-2.64
(2.78)
|
-2.69
(2.83)
|
-2.57
(2.81)
|
-2.90
(2.64)
|
-1.55
(2.17)
|
| Change at Week 16 |
-2.23
(2.63)
|
-2.47
(2.65)
|
-2.70
(2.45)
|
-2.88
(2.59)
|
-1.63
(2.46)
|
-2.62
(2.78)
|
-2.53
(2.73)
|
-2.59
(2.87)
|
-2.89
(2.75)
|
-1.75
(2.24)
|
| Change at Week 24 |
-2.26
(2.73)
|
-2.38
(2.71)
|
-2.48
(2.55)
|
-2.66
(2.73)
|
-1.74
(2.53)
|
-2.35
(2.84)
|
-2.57
(2.71)
|
-2.60
(2.99)
|
-2.83
(2.78)
|
-1.84
(2.44)
|
| Change at Week 32 |
-2.12
(2.75)
|
-2.28
(2.74)
|
-2.43
(2.72)
|
-2.62
(2.84)
|
-1.70
(2.52)
|
-2.27
(2.80)
|
-2.50
(2.84)
|
-2.52
(2.98)
|
-2.55
(2.90)
|
-1.78
(2.48)
|
| Change at Week 40 |
-2.06
(2.66)
|
-2.21
(2.73)
|
-2.09
(2.59)
|
-2.41
(2.80)
|
-1.51
(2.45)
|
-2.31
(2.78)
|
-2.28
(2.77)
|
-2.26
(2.95)
|
-2.47
(2.87)
|
-1.76
(2.46)
|
| Change at Week 48 |
-1.99
(2.69)
|
-2.17
(2.74)
|
-2.10
(2.74)
|
-2.29
(2.74)
|
-1.48
(2.47)
|
-2.20
(2.79)
|
-2.24
(2.84)
|
-2.30
(2.91)
|
-2.31
(2.89)
|
-1.64
(2.47)
|
| Change at Week 56 |
-2.00
(2.70)
|
-2.08
(2.76)
|
-2.10
(2.72)
|
-2.24
(2.70)
|
-1.43
(2.45)
|
-2.16
(2.75)
|
-1.98
(2.78)
|
-2.16
(2.89)
|
-2.34
(2.84)
|
-1.71
(2.51)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. |
| Time Frame | Baseline, Weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| General health at baseline |
56.76
(20.74)
|
57.41
(21.03)
|
60.66
(20.88)
|
57.92
(22.08)
|
57.61
(21.97)
|
56.20
(20.62)
|
56.93
(20.48)
|
56.34
(20.39)
|
58.27
(20.65)
|
55.69
(22.22)
|
| Physical function at baseline |
32.82
(19.12)
|
32.74
(21.34)
|
34.79
(20.63)
|
33.88
(18.66)
|
35.46
(19.94)
|
33.43
(20.62)
|
34.79
(19.21)
|
33.41
(22.07)
|
35.11
(20.48)
|
32.81
(19.57)
|
| Role physical at baseline |
43.29
(25.54)
|
43.88
(23.81)
|
44.58
(23.90)
|
44.69
(23.60)
|
46.09
(24.57)
|
42.59
(23.69)
|
42.86
(23.46)
|
42.65
(24.90)
|
45.60
(22.57)
|
43.55
(22.70)
|
| Bodily pain at baseline |
36.91
(17.91)
|
35.90
(17.87)
|
37.80
(17.49)
|
37.67
(17.89)
|
35.72
(16.34)
|
34.14
(16.39)
|
35.57
(18.00)
|
34.11
(16.66)
|
36.47
(16.93)
|
36.96
(17.60)
|
| Vitality at baseline |
51.58
(19.45)
|
51.28
(20.10)
|
53.73
(19.83)
|
52.57
(19.76)
|
50.78
(18.94)
|
50.52
(18.21)
|
51.52
(21.07)
|
51.45
(19.16)
|
53.63
(18.42)
|
51.52
(17.90)
|
| Social function at baseline |
65.63
(25.65)
|
65.97
(26.68)
|
68.13
(24.43)
|
64.47
(25.28)
|
62.23
(26.33)
|
63.19
(24.26)
|
63.68
(25.44)
|
64.51
(24.58)
|
66.90
(24.16)
|
64.31
(24.07)
|
| Role emotional at baseline |
66.08
(29.30)
|
66.35
(28.15)
|
67.74
(29.39)
|
67.92
(29.42)
|
68.45
(28.65)
|
63.02
(28.66)
|
64.07
(28.31)
|
62.68
(29.21)
|
65.05
(28.53)
|
63.39
(28.73)
|
| Mental health at baseline |
70.42
(19.16)
|
70.23
(19.71)
|
72.20
(19.67)
|
70.40
(18.77)
|
70.34
(19.78)
|
70.95
(17.94)
|
71.08
(19.16)
|
68.25
(19.23)
|
71.07
(19.83)
|
69.08
(18.69)
|
| Change at Week 12: General health |
3.29
(14.32)
|
4.66
(15.19)
|
3.66
(15.27)
|
5.14
(15.96)
|
3.88
(15.25)
|
5.46
(14.25)
|
3.37
(15.13)
|
5.18
(13.96)
|
5.66
(16.53)
|
4.68
(16.00)
|
| Change at Week 12: Physical function |
11.68
(22.48)
|
12.88
(21.49)
|
14.23
(25.26)
|
14.38
(24.59)
|
5.76
(21.38)
|
12.70
(22.24)
|
9.05
(22.01)
|
13.84
(24.37)
|
12.99
(24.30)
|
7.48
(18.88)
|
| Change at Week 12: Role physical |
9.73
(25.90)
|
12.59
(24.75)
|
13.13
(24.85)
|
15.39
(26.13)
|
6.70
(23.58)
|
13.36
(25.67)
|
10.04
(26.31)
|
15.51
(26.62)
|
13.71
(25.39)
|
7.58
(23.58)
|
| Change at Week 12: Bodily pain |
11.44
(21.66)
|
13.08
(21.93)
|
14.41
(22.41)
|
16.53
(22.55)
|
7.83
(19.22)
|
16.74
(21.52)
|
12.50
(22.60)
|
17.15
(23.61)
|
16.83
(22.01)
|
8.01
(19.68)
|
| Change at Week 12: Vitality |
5.68
(17.68)
|
5.14
(17.69)
|
6.47
(17.84)
|
6.12
(18.16)
|
3.97
(15.62)
|
7.41
(17.89)
|
4.35
(17.88)
|
6.32
(17.13)
|
6.47
(17.88)
|
2.43
(15.51)
|
| Change at Week 12: Social function |
5.90
(24.79)
|
5.25
(23.40)
|
5.36
(23.74)
|
7.76
(23.66)
|
7.41
(24.36)
|
10.19
(25.95)
|
5.36
(25.97)
|
8.14
(24.30)
|
8.94
(23.90)
|
3.33
(23.87)
|
| Change at Week 12: Role emotional |
5.08
(26.90)
|
5.50
(25.83)
|
4.91
(25.97)
|
4.47
(24.64)
|
0.92
(23.38)
|
8.23
(28.14)
|
3.64
(28.43)
|
8.63
(26.82)
|
6.82
(26.37)
|
4.13
(24.69)
|
| Change at Week 12: Mental health |
2.85
(17.25)
|
3.28
(15.58)
|
0.96
(16.77)
|
3.04
(15.36)
|
1.57
(15.44)
|
3.00
(15.55)
|
0.36
(16.85)
|
3.78
(17.45)
|
3.17
(17.39)
|
0.67
(15.99)
|
| Change at Week 24: General health |
3.08
(13.39)
|
2.95
(15.61)
|
3.77
(14.43)
|
4.54
(14.38)
|
2.90
(14.43)
|
4.07
(15.59)
|
4.25
(16.34)
|
3.46
(14.82)
|
4.28
(15.77)
|
3.90
(15.80)
|
| Change at Week 24: Physical function |
10.52
(21.56)
|
9.50
(22.90)
|
9.83
(22.63)
|
12.30
(24.18)
|
5.75
(19.12)
|
10.40
(22.45)
|
9.33
(19.85)
|
11.83
(23.45)
|
12.00
(23.60)
|
8.00
(18.72)
|
| Change at Week 24: Role physical |
9.40
(25.04)
|
7.42
(26.32)
|
9.58
(25.13)
|
11.54
(25.10)
|
7.28
(22.16)
|
10.24
(23.60)
|
10.46
(25.88)
|
10.93
(25.86)
|
10.50
(23.87)
|
7.70
(20.85)
|
| Change at Week 24: Bodily pain |
10.73
(21.66)
|
9.63
(22.77)
|
10.41
(21.52)
|
13.04
(21.24)
|
8.87
(19.60)
|
10.69
(21.07)
|
10.22
(23.32)
|
14.02
(23.34)
|
13.47
(21.19)
|
8.72
(19.45)
|
| Change at Week 24: Vitality |
5.94
(16.70)
|
3.93
(18.24)
|
3.77
(16.18)
|
4.52
(16.59)
|
1.90
(14.77)
|
5.71
(17.61)
|
4.00
(18.26)
|
2.84
(17.03)
|
4.15
(16.64)
|
2.87
(16.25)
|
| Change at Week 24: Social function |
4.01
(25.13)
|
3.21
(26.84)
|
3.21
(22.32)
|
6.14
(22.56)
|
6.16
(23.26)
|
7.63
(23.13)
|
6.25
(25.58)
|
7.06
(25.35)
|
5.78
(22.67)
|
4.07
(21.74)
|
| Change at Week 24: Role emotional |
3.35
(23.83)
|
0.58
(25.64)
|
2.38
(22.42)
|
2.16
(22.64)
|
2.92
(22.96)
|
5.81
(26.42)
|
4.95
(25.97)
|
6.47
(24.20)
|
3.39
(24.12)
|
2.23
(23.18)
|
| Change at Week 24: Mental health |
2.31
(17.07)
|
1.48
(16.93)
|
0.95
(15.78)
|
2.26
(15.92)
|
1.52
(14.67)
|
1.33
(14.50)
|
0.42
(15.32)
|
0.94
(15.01)
|
0.87
(16.48)
|
0.00
(16.15)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. |
| Time Frame | Baseline, Weeks 12, 24, 40, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Change at Week 12: General health |
3.29
(14.32)
|
4.66
(15.19)
|
3.66
(15.27)
|
5.14
(15.96)
|
3.88
(15.25)
|
5.46
(14.25)
|
3.37
(15.13)
|
5.18
(13.96)
|
5.66
(16.53)
|
4.68
(16.00)
|
| Change at Week 12: Physical function |
32.82
(19.12)
|
32.74
(21.34)
|
34.79
(20.63)
|
33.88
(18.66)
|
35.46
(19.94)
|
12.70
(22.24)
|
9.05
(22.01)
|
13.84
(24.37)
|
12.99
(24.30)
|
7.48
(18.88)
|
| Change at Week 12: Role physical |
43.29
(25.54)
|
43.88
(23.81)
|
44.58
(23.90)
|
44.69
(23.60)
|
46.09
(24.57)
|
13.36
(25.67)
|
10.04
(26.31)
|
15.51
(26.62)
|
13.71
(25.39)
|
7.58
(23.58)
|
| Change at Week 12: Bodily pain |
11.44
(21.66)
|
13.08
(21.93)
|
14.41
(22.41)
|
16.53
(22.55)
|
7.83
(19.22)
|
16.74
(21.52)
|
12.50
(22.60)
|
17.15
(23.61)
|
16.83
(22.01)
|
8.01
(19.68)
|
| Change at Week 12: Vitality |
5.68
(17.68)
|
5.14
(17.69)
|
6.47
(17.84)
|
6.12
(18.16)
|
3.97
(15.62)
|
7.41
(17.89)
|
4.35
(17.88)
|
6.32
(17.13)
|
6.47
(17.88)
|
2.43
(15.51)
|
| Change at Week 12: Social function |
5.90
(24.79)
|
5.25
(23.40)
|
5.36
(23.74)
|
7.76
(23.66)
|
7.41
(24.36)
|
10.19
(25.95)
|
5.36
(25.97)
|
8.14
(24.30)
|
8.94
(23.90)
|
3.33
(23.87)
|
| Change at Week 12: Role emotional |
5.08
(26.90)
|
5.50
(25.83)
|
4.91
(25.97)
|
4.47
(24.64)
|
0.92
(23.38)
|
8.23
(28.14)
|
3.64
(28.43)
|
8.63
(26.82)
|
6.82
(26.37)
|
4.13
(24.69)
|
| Change at Week 12: Mental health |
2.85
(17.25)
|
3.28
(15.58)
|
0.96
(16.77)
|
3.04
(15.36)
|
1.57
(15.44)
|
3.00
(15.55)
|
0.36
(16.85)
|
3.78
(17.45)
|
3.17
(17.39)
|
0.67
(15.99)
|
| Change at Week 24: General health |
3.95
(14.92)
|
3.18
(16.54)
|
3.93
(16.09)
|
4.66
(15.46)
|
3.77
(16.48)
|
4.42
(15.98)
|
4.59
(17.08)
|
3.72
(15.54)
|
4.62
(16.60)
|
4.45
(16.75)
|
| Change at Week 24: Physical function |
11.70
(22.93)
|
11.35
(24.40)
|
10.85
(24.77)
|
13.73
(24.60)
|
6.43
(21.08)
|
11.23
(23.56)
|
10.00
(21.47)
|
12.92
(24.02)
|
12.91
(24.35)
|
8.41
(20.14)
|
| Change at Week 24: Role physical |
11.14
(26.65)
|
9.53
(28.68)
|
10.71
(26.82)
|
13.03
(26.16)
|
7.97
(24.14)
|
11.74
(24.66)
|
11.84
(27.30)
|
11.84
(27.49)
|
12.45
(24.96)
|
8.27
(22.89)
|
| Change at Week 24: Bodily pain |
12.95
(22.92)
|
11.63
(24.07)
|
11.75
(23.05)
|
14.73
(21.67)
|
9.19
(21.10)
|
12.24
(21.85)
|
12.00
(24.21)
|
15.22
(24.37)
|
14.83
(21.76)
|
9.09
(20.09)
|
| Change at Week 24: Vitality |
7.17
(18.11)
|
4.34
(18.95)
|
4.42
(18.09)
|
5.48
(18.13)
|
2.57
(16.19)
|
5.95
(18.32)
|
4.87
(19.75)
|
3.09
(17.82)
|
4.50
(18.07)
|
2.40
(17.96)
|
| Change at Week 24: Social function |
5.19
(27.51)
|
3.56
(28.56)
|
2.81
(24.00)
|
7.11
(23.55)
|
7.32
(25.07)
|
8.51
(24.64)
|
7.09
(27.25)
|
7.35
(26.34)
|
6.57
(24.56)
|
3.97
(24.47)
|
| Change at Week 24: Role emotional |
5.22
(26.39)
|
1.56
(27.95)
|
3.63
(24.03)
|
3.10
(24.18)
|
2.59
(25.68)
|
6.73
(28.21)
|
5.09
(28.41)
|
6.83
(25.37)
|
4.58
(26.67)
|
2.76
(25.33)
|
| Change at Week 24: Mental health |
2.90
(18.22)
|
1.51
(17.97)
|
0.45
(17.97)
|
2.65
(16.96)
|
1.38
(16.71)
|
1.37
(15.33)
|
0.30
(16.71)
|
1.39
(15.75)
|
1.06
(18.13)
|
0.20
(18.25)
|
| Change at Week 40: General health |
3.40
(15.54)
|
2.45
(16.52)
|
2.83
(16.57)
|
3.87
(16.28)
|
3.47
(16.07)
|
3.74
(15.63)
|
3.31
(16.35)
|
3.20
(15.93)
|
3.45
(16.95)
|
4.09
(16.42)
|
| Change at Week 40: Physical function |
10.00
(22.96)
|
10.23
(24.17)
|
10.49
(24.89)
|
11.96
(25.30)
|
6.23
(19.34)
|
9.91
(22.72)
|
8.74
(21.92)
|
12.32
(24.17)
|
11.78
(25.11)
|
7.24
(20.71)
|
| Change at Week 40: Role physical |
9.64
(26.06)
|
8.79
(27.05)
|
10.98
(26.99)
|
10.00
(26.77)
|
7.01
(23.65)
|
11.32
(25.78)
|
10.53
(26.49)
|
12.38
(28.71)
|
12.13
(24.46)
|
7.58
(23.43)
|
| Change at Week 40: Bodily pain |
11.27
(23.45)
|
10.73
(23.77)
|
10.79
(23.42)
|
12.42
(21.98)
|
7.11
(19.38)
|
11.45
(21.91)
|
10.87
(23.44)
|
13.96
(23.88)
|
13.28
(21.69)
|
8.17
(19.11)
|
| Change at Week 40: Vitality |
5.92
(17.95)
|
3.30
(19.26)
|
4.42
(18.61)
|
4.45
(18.58)
|
2.32
(17.09)
|
5.29
(18.95)
|
4.40
(19.47)
|
3.24
(17.68)
|
4.17
(16.83)
|
2.67
(18.06)
|
| Social function at Week 40 |
4.05
(27.36)
|
3.21
(28.09)
|
2.19
(23.43)
|
4.56
(25.07)
|
7.23
(24.46)
|
7.43
(25.14)
|
6.20
(27.82)
|
6.03
(25.56)
|
6.23
(25.29)
|
2.65
(25.28)
|
| Change at Week 40: Role emotional |
4.08
(27.04)
|
1.91
(26.29)
|
2.80
(24.30)
|
0.76
(25.47)
|
1.61
(26.00)
|
6.69
(27.88)
|
2.99
(30.27)
|
5.98
(27.72)
|
5.47
(26.06)
|
3.41
(27.05)
|
| Change at Week 40: Mental health |
2.16
(19.27)
|
1.41
(17.56)
|
0.25
(18.14)
|
1.76
(16.34)
|
0.49
(16.26)
|
1.22
(16.42)
|
0.26
(18.11)
|
1.22
(15.48)
|
1.11
(17.41)
|
0.82
(18.76)
|
| Change at Week 56: General health |
3.12
(15.53)
|
2.31
(16.84)
|
2.59
(16.83)
|
3.69
(16.54)
|
3.33
(16.26)
|
3.75
(14.82)
|
3.41
(16.14)
|
3.10
(15.85)
|
3.75
(16.71)
|
3.99
(16.87)
|
| Change at Week 56: Physical function |
9.95
(22.78)
|
9.19
(24.31)
|
10.19
(24.94)
|
11.15
(25.00)
|
5.95
(19.75)
|
10.12
(22.91)
|
8.25
(21.73)
|
12.07
(24.08)
|
11.48
(24.80)
|
6.91
(20.39)
|
| Change at Week 56: Role physical |
9.13
(26.00)
|
8.01
(27.09)
|
10.49
(26.86)
|
9.01
(26.81)
|
7.19
(23.29)
|
11.20
(25.54)
|
10.46
(26.83)
|
11.96
(28.82)
|
12.06
(24.38)
|
7.28
(23.78)
|
| Change at Week 56: Bodily pain |
11.58
(23.00)
|
10.21
(24.18)
|
10.38
(23.28)
|
11.92
(22.25)
|
7.47
(19.17)
|
11.52
(21.79)
|
10.32
(23.48)
|
13.53
(24.12)
|
13.36
(21.53)
|
8.69
(19.35)
|
| Change at Week 56: Vitality |
5.70
(18.10)
|
3.10
(19.16)
|
4.17
(18.73)
|
3.82
(18.90)
|
2.68
(16.53)
|
4.82
(18.47)
|
4.47
(19.74)
|
3.41
(17.70)
|
4.15
(16.66)
|
2.08
(17.89)
|
| Change at Week 56: Social function |
4.53
(26.95)
|
2.95
(28.04)
|
1.65
(23.40)
|
3.99
(24.98)
|
7.23
(23.97)
|
7.73
(25.15)
|
6.10
(27.69)
|
6.23
(26.15)
|
6.67
(24.59)
|
2.84
(25.01)
|
| Change at Week 56: Role emotional |
4.23
(28.30)
|
1.53
(26.76)
|
1.99
(24.59)
|
0.47
(25.50)
|
1.67
(25.90)
|
6.10
(28.74)
|
3.25
(30.06)
|
6.11
(28.11)
|
5.07
(26.11)
|
3.51
(27.41)
|
| Change at Week 56: Mental health |
2.28
(19.24)
|
1.42
(17.72)
|
-0.11
(18.49)
|
1.53
(16.55)
|
0.41
(16.13)
|
1.10
(16.47)
|
0.18
(18.05)
|
1.47
(15.63)
|
1.25
(17.22)
|
0.96
(18.44)
|
| Title | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy |
|---|---|
| Description | |
| Time Frame | Baseline up to Week 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Count of Participants [Participants] |
23
8.1%
|
23
8%
|
22
7.9%
|
15
5.2%
|
40
14.1%
|
19
7.4%
|
21
8.3%
|
15
5.9%
|
18
7.1%
|
38
14.8%
|
| Title | Time to Discontinuation Due to Lack of Efficacy |
|---|---|
| Description | Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy. |
| Time Frame | Baseline up to Week 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Mean (Standard Error) [days] |
319.87
(3.74)
|
331.69
(3.65)
|
394.80
(5.08)
|
271.89
(2.66)
|
306.11
(4.94)
|
329.79
(3.68)
|
314.16
(4.15)
|
334.84
(3.08)
|
324.25
(3.32)
|
303.08
(5.10)
|
| Title | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 101 | 103 | 99 | 121 | 114 | 76 | 77 | 92 | 84 | 90 |
| Mean (Standard Deviation) [change in percent work time missed] |
-0.88
(11.54)
|
0.04
(8.16)
|
0.63
(6.23)
|
-0.77
(15.75)
|
1.11
(12.55)
|
-2.85
(10.19)
|
-0.42
(12.87)
|
1.51
(11.21)
|
-1.64
(9.60)
|
-0.61
(8.36)
|
| Title | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Week 24 and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 101 | 103 | 99 | 121 | 114 | 76 | 77 | 92 | 84 | 90 |
| Change at Week 24 |
-0.88
(11.54)
|
0.04
(8.16)
|
0.63
(6.23)
|
0.77
(15.75)
|
1.11
(12.55)
|
-2.85
(10.19)
|
-0.42
(12.87)
|
1.51
(11.21)
|
-1.64
(9.60)
|
-0.61
(8.36)
|
| Change at Week 56 |
-1.10
(11.30)
|
-0.39
(9.29)
|
1.08
(7.57)
|
-0.41
(16.46)
|
2.26
(13.76)
|
-3.06
(9.98)
|
-0.46
(12.88)
|
1.51
(11.21)
|
-1.64
(9.60)
|
-0.82
(7.94)
|
| Title | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 100 | 101 | 98 | 120 | 113 | 73 | 73 | 89 | 80 | 86 |
| Mean (Standard Deviation) [change in percent impairment] |
-11.90
(22.32)
|
-11.68
(24.74)
|
-5.51
(26.33)
|
-13.00
(27.34)
|
-7.35
(29.03)
|
-17.81
(22.00)
|
-13.01
(25.91)
|
-9.33
(22.40)
|
-9.63
(23.68)
|
-5.81
(22.62)
|
| Title | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Weeks 24 and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 100 | 101 | 98 | 120 | 113 | 73 | 73 | 89 | 80 | 86 |
| Change at Week 24 |
-11.90
(22.32)
|
-11.68
(24.74)
|
-5.51
(26.33)
|
-13.00
(27.34)
|
-7.35
(29.03)
|
-17.81
(22.00)
|
-13.01
(25.91)
|
-9.33
(22.40)
|
-9.63
(23.68)
|
-5.81
(22.62)
|
| Change at Week 56 |
-10.30
(23.11)
|
-11.88
(24.85)
|
-4.08
(25.92)
|
-11.33
(27.19)
|
-5.31
(28.51)
|
-16.99
(22.09)
|
-12.88
(27.00)
|
-8.09
(24.58)
|
-4.25
(42.03)
|
-5.93
(22.30)
|
| Title | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 101 | 103 | 99 | 121 | 114 | 77 | 254 | 92 | 84 | 90 |
| Mean (Standard Deviation) [change in percent work impairment] |
-5.40
(31.08)
|
-1.46
(24.95)
|
-0.75
(18.60)
|
-1.35
(29.85)
|
2.09
(28.55)
|
-10.17
(26.46)
|
-0.22
(22.51)
|
1.25
(26.81)
|
-4.30
(24.16)
|
-2.29
(23.87)
|
| Title | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Weeks 24 and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 101 | 103 | 99 | 121 | 114 | 76 | 77 | 92 | 84 | 90 |
| Change at Week 24 |
-5.40
(31.08)
|
-1.46
(24.95)
|
-0.75
(18.60)
|
-1.35
(29.85)
|
2.09
(28.55)
|
-10.17
(26.46)
|
-0.22
(22.51)
|
1.25
(26.81)
|
-4.30
(24.16)
|
-2.29
(23.87)
|
| Change at Week 56 |
-6.08
(30.20)
|
-1.88
(26.61)
|
0.77
(22.05)
|
-0.85
(31.85)
|
4.11
(27.38)
|
-10.32
(26.52)
|
-1.01
(23.22)
|
1.25
(26.81)
|
-4.30
(24.16)
|
-3.02
(21.60)
|
| Title | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 283 | 287 | 279 | 284 | 280 | 254 | 250 | 255 | 249 | 253 |
| Mean (Standard Deviation) [change in percent activity impairment] |
-12.30
(25.61)
|
-15.51
(26.17)
|
-13.55
(26.42)
|
-14.96
(26.74)
|
-10.00
(25.92)
|
-17.24
(25.11)
|
-17.84
(25.81)
|
-18.04
(25.47)
|
-17.31
(26.28)
|
-11.90
(26.06)
|
| Title | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) |
|---|---|
| Description | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Time Frame | Baseline, Weeks 24, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 283 | 287 | 279 | 284 | 280 | 254 | 250 | 255 | 249 | 253 |
| Change at Week 24 |
-12.30
(25.61)
|
-15.51
(26.17)
|
-13.55
(26.42)
|
-14.96
(26.74)
|
-10.00
(25.92)
|
-17.24
(25.11)
|
-17.84
(25.81)
|
-18.04
(25.47)
|
-17.31
(26.28)
|
-11.90
(26.06)
|
| Change at Week 56 |
-12.12
(25.37)
|
-14.77
(26.72)
|
-12.19
(27.03)
|
-13.20
(26.58)
|
-9.32
(24.93)
|
-15.39
(23.53)
|
-15.76
(27.09)
|
-18.04
(25.93)
|
-15.86
(26.91)
|
-11.19
(26.55)
|
| Title | Percentage of Participants Who Used Rescue Medication: Observed Data |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. |
| Time Frame | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Weeks 1-2 |
60.5
21.2%
|
59.3
20.6%
|
57.6
20.6%
|
62.9
21.8%
|
61.9
21.9%
|
69.7
27.2%
|
64.2
25.3%
|
60.2
23.5%
|
62.5
24.6%
|
63.2
24.7%
|
| Weeks 3-4 |
63.3
22.2%
|
61.8
21.5%
|
55.1
19.7%
|
60.6
21%
|
62.3
22%
|
68.4
26.7%
|
64.9
25.6%
|
59.3
23.2%
|
60.3
23.7%
|
66.0
25.8%
|
| Weeks 5-8 |
67.7
23.8%
|
64.7
22.5%
|
55.1
19.7%
|
57.9
20.1%
|
68.8
24.3%
|
68.0
26.6%
|
61.2
24.1%
|
62.5
24.4%
|
63.9
25.2%
|
66.7
26.1%
|
| Weeks 9-12 |
67.8
23.8%
|
65.3
22.7%
|
56.3
20.1%
|
61.4
21.3%
|
64.8
22.9%
|
62.9
24.6%
|
64.5
25.4%
|
60.3
23.6%
|
57.1
22.5%
|
65.9
25.7%
|
| Weeks 13-16 |
66.7
23.4%
|
63.7
22.1%
|
62.1
22.2%
|
57.8
20.1%
|
68.1
24.1%
|
64.2
25.1%
|
61.3
24.1%
|
62.3
24.3%
|
57.8
22.8%
|
68.8
26.9%
|
| Weeks 17-24 |
68.9
24.2%
|
67.0
23.3%
|
64.7
23.1%
|
66.0
22.9%
|
76.6
27.1%
|
67.0
26.2%
|
65.1
25.6%
|
59.4
23.2%
|
66.2
26.1%
|
66.3
25.9%
|
| Weeks 25-32 |
66.0
23.2%
|
67.3
23.4%
|
59.1
21.1%
|
59.6
20.7%
|
69.5
24.6%
|
66.5
26%
|
70.2
27.6%
|
63.5
24.8%
|
66.2
26.1%
|
71.2
27.8%
|
| Weeks 33-40 |
64.4
22.6%
|
69.5
24.1%
|
58.2
20.8%
|
61.8
21.5%
|
73.7
26%
|
63.8
24.9%
|
71.2
28%
|
64.8
25.3%
|
61.8
24.3%
|
61.6
24.1%
|
| Weeks 41-48 |
66.7
23.4%
|
62.5
21.7%
|
59.2
21.1%
|
60.9
21.1%
|
66.0
23.3%
|
64.1
25%
|
70.7
27.8%
|
63.3
24.7%
|
52.5
20.7%
|
65.1
25.4%
|
| Weeks 49-56 |
69.2
24.3%
|
71.1
24.7%
|
62.9
22.5%
|
74.2
25.8%
|
78.2
27.6%
|
75.9
29.6%
|
74.1
29.2%
|
72.4
28.3%
|
79.3
31.2%
|
77.5
30.3%
|
| Title | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. |
| Time Frame | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Weeks 1-2 |
60.4
21.2%
|
59.4
20.6%
|
56.9
20.3%
|
63.0
21.9%
|
63.0
22.3%
|
70.0
27.3%
|
64.4
25.4%
|
60.5
23.6%
|
62.7
24.7%
|
63.1
24.6%
|
| Weeks 3-4 |
63.0
22.1%
|
61.7
21.4%
|
54.7
19.5%
|
60.7
21.1%
|
63.0
22.3%
|
69.4
27.1%
|
64.4
25.4%
|
59.2
23.1%
|
61.1
24.1%
|
66.0
25.8%
|
| Weeks 5-8 |
66.5
23.3%
|
63.8
22.2%
|
55.0
19.6%
|
58.9
20.5%
|
69.8
24.7%
|
69.8
27.3%
|
61.0
24%
|
62.4
24.4%
|
64.3
25.3%
|
67.6
26.4%
|
| Weeks 9-12 |
65.8
23.1%
|
64.2
22.3%
|
55.4
19.8%
|
60.3
20.9%
|
66.2
23.4%
|
65.1
25.4%
|
63.9
25.2%
|
60.5
23.6%
|
59.3
23.3%
|
68.4
26.7%
|
| Weeks 13-16 |
65.3
22.9%
|
62.5
21.7%
|
60.0
21.4%
|
57.8
20.1%
|
69.4
24.5%
|
67.5
26.4%
|
62.3
24.5%
|
62.5
24.4%
|
59.7
23.5%
|
70.7
27.6%
|
| Weeks 17-24 |
68.1
23.9%
|
64.6
22.4%
|
63.2
22.6%
|
64.5
22.4%
|
75.8
26.8%
|
69.8
27.3%
|
64.3
25.3%
|
60.9
23.8%
|
65.6
25.8%
|
69.1
27%
|
| Weeks 25-32 |
66.7
23.4%
|
64.9
22.5%
|
60.0
21.4%
|
63.1
21.9%
|
70.8
25%
|
71.8
28%
|
67.5
26.6%
|
63.7
24.9%
|
66.4
26.1%
|
74.2
29%
|
| Weeks 33-40 |
68.1
23.9%
|
66.3
23%
|
61.8
22.1%
|
64.1
22.3%
|
71.9
25.4%
|
71.4
27.9%
|
67.5
26.6%
|
62.9
24.6%
|
65.2
25.7%
|
71.5
27.9%
|
| Weeks 41-48 |
69.5
24.4%
|
66.0
22.9%
|
63.9
22.8%
|
64.8
22.5%
|
71.5
25.3%
|
71.4
27.9%
|
67.9
26.7%
|
63.7
24.9%
|
65.0
25.6%
|
72.3
28.2%
|
| Weeks 49-56 |
71.2
25%
|
69.1
24%
|
65.4
23.4%
|
67.6
23.5%
|
72.6
25.7%
|
71.5
27.9%
|
70.0
27.6%
|
66.8
26.1%
|
68.1
26.8%
|
71.5
27.9%
|
| Title | Amount of Rescue Medication Used |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized. |
| Time Frame | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Weeks 1-2 |
3144.66
(6878.90)
|
3365.46
(8829.47)
|
2739.96
(7060.72)
|
3524.27
(5665.78)
|
3543.99
(5541.14)
|
3132.30
(4047.15)
|
3834.79
(7152.17)
|
2910.68
(4285.74)
|
3250.69
(4846.02)
|
3455.85
(8154.84)
|
| Weeks 3-4 |
3411.93
(6929.86)
|
3582.77
(8814.22)
|
2660.11
(6782.71)
|
3066.65
(5206.51)
|
3415.52
(5260.63)
|
3255.16
(4142.25)
|
3769.17
(7131.76)
|
2672.18
(4108.60)
|
3011.67
(4412.94)
|
3281.23
(6981.13)
|
| Weeks 5-8 |
2846.58
(6532.40)
|
2875.55
(8372.63)
|
2131.45
(6429.73)
|
2396.99
(4684.26)
|
2991.01
(4634.26)
|
2571.99
(3240.96)
|
2969.34
(6656.34)
|
2140.44
(3585.06)
|
2223.15
(3624.98)
|
3182.45
(6991.76)
|
| Weeks 9-12 |
2863.10
(6547.23)
|
2955.84
(8403.06)
|
2291.41
(6478.22)
|
2415.93
(4630.96)
|
2919.20
(4643.38)
|
2380.78
(3162.61)
|
3008.85
(6675.65)
|
2166.23
(3632.39)
|
2266.13
(3753.34)
|
3067.56
(6962.68)
|
| Weeks 13-16 |
2993.63
(6587.61)
|
2912.14
(8426.72)
|
2562.94
(6525.59)
|
2551.21
(4793.92)
|
2920.39
(4659.70)
|
2450.55
(3280.41)
|
2938.95
(6667.26)
|
2244.74
(3642.93)
|
2486.23
(3933.41)
|
3269.78
(7040.71)
|
| Weeks 17-24 |
2733.43
(6432.63)
|
2778.55
(8311.86)
|
2525.71
(6490.27)
|
2261.93
(4517.29)
|
2759.90
(4426.38)
|
2261.84
(2980.00)
|
2725.86
(6619.25)
|
2235.23
(3702.39)
|
2370.30
(3599.96)
|
2816.00
(6854.35)
|
| Weeks 25-32 |
2823.39
(6441.86)
|
2824.83
(8313.77)
|
2548.20
(6512.08)
|
2289.28
(4563.36)
|
2792.04
(4555.75)
|
2383.27
(3102.23)
|
2927.44
(6606.26)
|
2432.81
(3783.30)
|
2723.26
(3891.04)
|
3126.26
(6906.75)
|
| Weeks 33-40 |
2810.18
(6445.83)
|
2900.69
(8319.96)
|
2608.91
(6529.78)
|
2361.40
(4541.68)
|
2755.66
(4503.88)
|
2449.87
(3126.73)
|
2976.37
(6607.95)
|
2428.51
(3758.09)
|
2682.35
(3925.96)
|
3032.17
(6889.07)
|
| Weeks 41-48 |
2927.31
(6460.58)
|
2906.70
(8324.75)
|
2673.48
(6517.91)
|
2373.66
(4547.39)
|
2746.29
(4498.19)
|
2521.27
(3163.27)
|
3033.87
(6627.43)
|
2408.58
(3706.60)
|
2618.83
(3864.42)
|
3101.63
(6912.29)
|
| Weeks 49-56 |
2979.89
(6413.29)
|
2910.73
(6626.26)
|
2938.47
(6717.61)
|
2545.36
(4465.07)
|
3106.46
(4908.02)
|
2840.21
(3627.85)
|
2770.28
(3810.98)
|
2511.61
(3797.81)
|
2842.74
(3642.86)
|
3035.33
(4124.28)
|
| Title | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen or Celecoxib Exposure) | Tanezumab 10 mg (Naproxen or Celecoxib Exposure) | Tanezumab 5 mg + NSAID | Tanezumab 10 mg + NSAID | NSAID |
|---|---|---|---|---|---|
| Arm/Group Description | Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. |
| Measure Participants | 448 | 449 | 446 | 452 | 446 |
| Baseline |
2.769
(2.077)
|
2.850
(2.077)
|
3.005
(2.068)
|
2.982
(2.106)
|
3.022
(2.090)
|
| Change at Week 56 |
-0.189
(0.970)
|
-0.213
(1.069)
|
-0.162
(1.069)
|
-0.172
(1.096)
|
-0.041
(0.850)
|
| Title | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 |
|---|---|
| Description | |
| Time Frame | Baseline, Week 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen or Celecoxib Exposure) | Tanezumab 10 mg (Naproxen or Celecoxib Exposure) | Tanezumab 5 mg + NSAID | Tanezumab 10 mg + NSAID | NSAID |
|---|---|---|---|---|---|
| Arm/Group Description | Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. |
| Measure Participants | 92 | 93 | 90 | 90 | 93 |
| Baseline |
2.447
(1.364)
|
2.372
(1.433)
|
2.346
(1.424)
|
2.195
(1.561)
|
2.724
(1.525)
|
| Change at Week 56 |
-0.075
(0.587)
|
-0.137
(0.619)
|
-0.240
(0.599)
|
-0.136
(0.437)
|
-0.028
(0.477)
|
| Title | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
|---|---|
| Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Time Frame | Baseline up to Week 64 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| AEs |
203
71.2%
|
211
73.3%
|
205
73.2%
|
207
71.9%
|
192
67.8%
|
202
78.9%
|
188
74%
|
185
72.3%
|
193
76%
|
172
67.2%
|
| SAEs |
22
7.7%
|
23
8%
|
28
10%
|
30
10.4%
|
22
7.8%
|
22
8.6%
|
23
9.1%
|
26
10.2%
|
34
13.4%
|
21
8.2%
|
| Title | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data |
|---|---|
| Description | The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Baseline |
2.64
(5.96)
|
2.56
(5.82)
|
1.93
(4.34)
|
2.54
(6.43)
|
2.31
(6.34)
|
2.04
(4.55)
|
2.09
(4.00)
|
2.24
(4.84)
|
2.08
(4.86)
|
2.18
(5.20)
|
| Change at Week 2 |
-0.20
(1.61)
|
-0.25
(2.27)
|
-0.30
(1.78)
|
-0.16
(1.98)
|
-0.11
(1.94)
|
-0.11
(1.87)
|
-0.29
(2.03)
|
-0.14
(1.60)
|
-0.33
(1.55)
|
-0.34
(1.17)
|
| Change at Week 4 |
-0.40
(1.93)
|
-0.42
(2.37)
|
-0.18
(1.68)
|
-0.29
(2.01)
|
-0.11
(2.20)
|
-0.20
(1.51)
|
-0.30
(1.93)
|
-0.41
(1.98)
|
-0.39
(2.27)
|
-0.11
(2.80)
|
| Change at Week 8 |
-0.47
(2.17)
|
-0.42
(2.40)
|
-0.22
(1.98)
|
-0.30
(2.05)
|
-0.12
(2.31)
|
-0.32
(2.05)
|
-0.36
(2.29)
|
-0.55
(2.08)
|
-0.22
(3.84)
|
-0.35
(2.06)
|
| Change at Week 12 |
-0.53
(2.38)
|
-0.38
(2.95)
|
-0.34
(2.28)
|
-0.62
(3.94)
|
-0.29
(2.65)
|
-0.52
(1.98)
|
-0.56
(2.37)
|
-0.72
(2.29)
|
-0.38
(3.84)
|
-0.44
(2.21)
|
| Change at Week 16 |
-0.81
(2.91)
|
-0.41
(2.62)
|
-0.38
(2.70)
|
-0.58
(2.82)
|
-0.26
(2.61)
|
-0.41
(2.25)
|
-0.64
(233)
|
-0.83
(2.41)
|
-0.48
(3.18)
|
-0.50
(2.47)
|
| Change at Week 24 |
-0.78
(3.26)
|
-0.50
(2.70)
|
-0.57
(2.27)
|
-0.57
(2.88)
|
-0.43
(2.52)
|
-0.37
(2.42)
|
-0.46
(2.47)
|
-0.99
(2.66)
|
-0.47
(2.83)
|
-0.50
(2.73)
|
| Change at Week 32 |
-0.56
(2.71)
|
-0.53
(2.64)
|
-0.78
(2.97)
|
-0.47
(3.51)
|
-0.39
(2.27)
|
-0.50
(2.61)
|
-0.71
(2.44)
|
-1.05
(2.97)
|
-0.49
(2.85)
|
-0.63
(2.72)
|
| Change at Week 40 |
-0.61
(2.37)
|
-0.47
(2.91)
|
-0.63
(2.75)
|
-0.38
(3.82)
|
-0.42
(2.77)
|
-0.42
(2.94)
|
-0.58
(2.37)
|
-1.06
(3.09)
|
-0.71
(2.73)
|
-0.73
(2.91)
|
| Change at Week 48 |
-0.55
(3.44)
|
-0.81
(2.56)
|
-0.67
(2.77)
|
-0.80
(3.46)
|
-0.48
(2.83)
|
-0.56
(2.74)
|
-0.65
(2.74)
|
-1.07
(3.49)
|
-0.50
(2.74)
|
-0.69
(3.14)
|
| Change at Week 56 |
-0.30
(5.01)
|
-0.70
(2.91)
|
-0.83
(4.14)
|
-0.10
(3.27)
|
-0.36
(2.68)
|
-0.53
(2.54)
|
-0.42
(2.51)
|
-1.01
(3.45)
|
-0.38
(2.04)
|
-0.54
(2.58)
|
| Title | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. |
| Time Frame | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Baseline |
2.64
(5.96)
|
2.56
(5.82)
|
1.93
(4.34)
|
2.54
(6.43)
|
2.31
(6.34)
|
2.04
(4.55)
|
2.09
(4.00)
|
2.24
(4.84)
|
2.08
(4.86)
|
2.18
(5.20)
|
| Change at Week 2 |
-0.20
(1.61)
|
-0.25
(2.27)
|
-0.30
(1.78)
|
-0.16
(1.98)
|
-0.11
(1.94)
|
-0.11
(1.87)
|
-0.29
(2.03)
|
-0.14
(1.60)
|
-0.33
(1.55)
|
-0.34
(1.71)
|
| Change at Week 4 |
-0.37
(1.88)
|
-0.46
(2.41)
|
-0.20
(1.66)
|
-0.33
(2.42)
|
-0.08
(2.20)
|
-0.21
(1.50)
|
-0.30
(1.90)
|
-0.40
(1.99)
|
-0.40
(2.24)
|
-0.13
(2.79)
|
| Change at Week 8 |
-0.49
(2.14)
|
-0.46
(2.38)
|
-0.25
(1.98)
|
-0.38
(2.51)
|
-0.12
(2.29)
|
-0.32
(2.00)
|
-0.35
(2.20)
|
-0.53
(2.06)
|
-0.33
(3.79)
|
-0.22
(2.96)
|
| Change at Week 12 |
-0.52
(2.33)
|
-0.43
(2.88)
|
-0.38
(2.25)
|
-0.65
(3.93)
|
-0.26
(2.54)
|
-0.53
(1.93)
|
-0.50
(2.34)
|
-0.69
(2.25)
|
-0.26
(4.78)
|
-0.28
(3.05)
|
| Change at Week 16 |
-0.77
(2.77)
|
-0.48
(2.58)
|
-0.35
(2.67)
|
-0.58
(3.02)
|
-0.18
(2.62)
|
-0.43
(2.15)
|
-0.56
(2.28)
|
-0.79
(2.35)
|
-0.30
(4.34)
|
-0.34
(3.20)
|
| Change at Week 24 |
-0.73
(3.07)
|
-0.57
(2.67)
|
-0.44
(2.21)
|
-0.60
(3.02)
|
-0.31
(2.49)
|
-0.35
(2.28)
|
-0.38
(2.31)
|
-0.90
(2.53)
|
-0.22
(4.47)
|
-0.36
(3.37)
|
| Change at Week 32 |
-0.56
(2.77)
|
-0.57
(2.77)
|
-0.52
(2.76)
|
-0.53
(3.41)
|
-0.32
(2.32)
|
-0.44
(2.38)
|
-0.56
(2.40)
|
-0.93
(2.72)
|
-0.26
(4.44)
|
-0.34
(3.46)
|
| Change at Week 40 |
-0.50
(2.65)
|
-0.55
(2.82)
|
-0.32
(2.56)
|
-0.49
(3.57)
|
-0.40
(2.73)
|
-0.41
(2.66)
|
-0.50
(2.37)
|
-0.50
(2.72)
|
-0.33
(4.34)
|
-0.39
(3.52)
|
| Change at Week 48 |
-0.43
(3.27)
|
-0.58
(2.71)
|
-0.38
(2.56)
|
-0.65
(3.20)
|
-0.43
(2.63)
|
-0.44
(2.40)
|
-0.52
(2.48)
|
-0.87
(2.90)
|
-0.34
(4.40)
|
-0.36
(3.51)
|
| Change at Week 56 |
-0.48
(3.83)
|
-0.53
(2.76)
|
-0.45
(2.95)
|
-0.58
(3.30)
|
-0.46
(2.72)
|
-0.41
(2.31)
|
-0.44
(2.58)
|
-0.89
(2.90)
|
-0.43
(4.45)
|
-0.41
(3.40)
|
| Title | Number of Participants With Anti-Drug Antibody (ADA) Response |
|---|---|
| Description | Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive. |
| Time Frame | Baseline, Weeks 16, 40, 24, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen or Celecoxib Exposure) | Tanezumab 10 mg (Naproxen or Celecoxib Exposure) | Tanezumab 5 mg + NSAID | Tanezumab 10 mg + NSAID |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. |
| Measure Participants | 541 | 542 | 536 | 542 |
| Baseline |
3
1.1%
|
2
0.7%
|
4
1.4%
|
2
0.7%
|
| Week 16 |
5
1.8%
|
3
1%
|
4
1.4%
|
0
0%
|
| Week 24 |
4
1.4%
|
2
0.7%
|
1
0.4%
|
1
0.3%
|
| Week 40 |
2
0.7%
|
2
0.7%
|
5
1.8%
|
2
0.7%
|
| Week 56 |
3
1.1%
|
2
0.7%
|
1
0.4%
|
2
0.7%
|
| Title | Plasma Trough (Pre-dose) Concentration of Tanezumab |
|---|---|
| Description | |
| Time Frame | Predose on Day 1, Weeks 16, 24, 40, and 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure and Number analyzed' signifies participants evaluable at specified time points. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen or Celecoxib Exposure) | Tanezumab 10 mg (Naproxen or Celecoxib Exposure) | Tanezumab 5 mg + NSAID | Tanezumab 10 mg + NSAID |
|---|---|---|---|---|
| Arm/Group Description | Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48. | Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. | Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48. |
| Measure Participants | 512 | 517 | 502 | 507 |
| Day 1 |
48.4570
(241.4173)
|
164.068
(1045.628)
|
102.398
(543.2856)
|
96.4720
(481.0747)
|
| Week 16 |
222.779
(228.0336)
|
556.854
(599.8115)
|
255.246
(400.3175)
|
723.316
(2791.080)
|
| Week 24 |
250.813
(375.3960)
|
545.672
(375.3960)
|
271.632
(368.0965)
|
538.756
(481.1859)
|
| Week 40 |
231.840
(211.3920)
|
523.214
(365.6468)
|
263.049
(289.5641)
|
527.108
(442.1378)
|
| Week 56 |
168.673
(307.1740)
|
385.733
(456.5163)
|
138.159
(253.3517)
|
377.231
(422.0123)
|
| Title | Number of Participants With Positive Urine or Serum Pregnancy Test |
|---|---|
| Description | Female participants, who reported positive in urine or serum pregnancy test were reported. |
| Time Frame | Baseline up to Week 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 200 | 208 | 184 | 192 | 199 | 192 | 184 | 179 | 177 | 189 |
| Count of Participants [Participants] |
0
0%
|
1
0.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Number of Participants With Intravenous (IV) Doses of Study Medication |
|---|---|
| Description | Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received. |
| Time Frame | Baseline up to Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). |
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. |
| Measure Participants | 285 | 288 | 280 | 288 | 283 | 256 | 254 | 256 | 254 | 256 |
| Number of IV Doses: 1 |
32
11.2%
|
36
12.5%
|
36
12.9%
|
44
15.3%
|
35
12.4%
|
25
9.8%
|
30
11.8%
|
22
8.6%
|
21
8.3%
|
22
8.6%
|
| Number of IV Doses: 2 |
19
6.7%
|
18
6.3%
|
19
6.8%
|
16
5.6%
|
30
10.6%
|
15
5.9%
|
19
7.5%
|
12
4.7%
|
12
4.7%
|
24
9.4%
|
| Number of IV Doses: 3 |
27
9.5%
|
28
9.7%
|
17
6.1%
|
21
7.3%
|
21
7.4%
|
13
5.1%
|
16
6.3%
|
18
7%
|
22
8.7%
|
12
4.7%
|
| Number of IV Doses: 4 |
41
14.4%
|
51
17.7%
|
51
18.2%
|
55
19.1%
|
44
15.5%
|
39
15.2%
|
35
13.8%
|
44
17.2%
|
48
18.9%
|
37
14.5%
|
| Number of IV Doses: 5 |
71
24.9%
|
70
24.3%
|
66
23.6%
|
74
25.7%
|
74
26.1%
|
82
32%
|
78
30.7%
|
84
32.8%
|
72
28.3%
|
73
28.5%
|
| Number of IV Doses: 6 |
45
15.8%
|
44
15.3%
|
45
16.1%
|
31
10.8%
|
33
11.7%
|
41
16%
|
34
13.4%
|
43
16.8%
|
38
15%
|
44
17.2%
|
| Number of IV Doses: 7 |
50
17.5%
|
41
14.2%
|
46
16.4%
|
47
16.3%
|
46
16.3%
|
41
16%
|
42
16.5%
|
33
12.9%
|
41
16.1%
|
44
17.2%
|
Adverse Events
| Time Frame | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492 | |||||||||||||||||||
| Arm/Group Title | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg | ||||||||||
| Arm/Group Description | Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/285 (7.7%) | 23/288 (8%) | 28/280 (10%) | 30/288 (10.4%) | 22/283 (7.8%) | 22/256 (8.6%) | 23/254 (9.1%) | 26/256 (10.2%) | 34/254 (13.4%) | 21/256 (8.2%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Anaemia | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Thrombocytopenia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Acute left ventricular failure | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Arteriosclerosis coronary artery | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Atrial fibrillation | 2/285 (0.7%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Atrioventricular block | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Bradycardia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Cardiac failure congestive | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Cardiac tamponade | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Cardio-respiratory arrest | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Coronary artery disease | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Left ventricular hypertrophy | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Myocardial ischaemia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Pericardial effusion | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Atrial flutter | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Right ventricular failure | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Ventricular tachycardia | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Ear pain | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Retinal detachment | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal pain | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Colitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Diarrhoea | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Dysphagia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Food poisoning | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Gastric ulcer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Gastritis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Hiatus hernia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Upper gastrointestinal haemorrhage | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 2/256 (0.8%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Vomiting | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Duodenal ulcer | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Enteritis | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Intestinal perforation | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Nausea | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Peptic ulcer perforation | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Chest pain | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 1/283 (0.4%) | 1/256 (0.4%) | 1/254 (0.4%) | 2/256 (0.8%) | 1/254 (0.4%) | 2/256 (0.8%) | ||||||||||
| Oedema peripheral | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||
| Bile duct obstruction | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Cholecystitis acute | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Gallbladder pain | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Cholelithiasis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 2/283 (0.7%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Cholecystitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Cellulitis | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Diverticulitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Gangrene | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pneumonia | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Septic shock | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Upper respiratory tract infection | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Urinary tract infection | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Viral infection | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Wound sepsis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Appendicitis | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Arthritis bacterial | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Arthritis infective | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Bronchitis | 0/285 (0%) | 1/288 (0.3%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Bursitis infective | 0/285 (0%) | 1/288 (0.3%) | 1/280 (0.4%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Influenza | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Localised infection | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Osteomyelitis | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pneumonia pneumococcal | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Sepsis | 1/285 (0.4%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Staphylococcal infection | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Subcutaneous abscess | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Contusion | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Extradural haematoma | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Fall | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 2/254 (0.8%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Femur fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 2/254 (0.8%) | 0/256 (0%) | ||||||||||
| Fractured sacrum | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Hip fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Joint dislocation | 0/285 (0%) | 0/288 (0%) | 2/280 (0.7%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Joint injury | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Multiple fractures | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Muscle rupture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pelvic fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Skeletal injury | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Spinal fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 2/254 (0.8%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Stress fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Synovial rupture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Tendon rupture | 0/285 (0%) | 1/288 (0.3%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Tibia fracture | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 2/288 (0.7%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Ankle fracture | 1/285 (0.4%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Chemical peritonitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Foot fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Fracture | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Humerus fracture | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Incisional hernia | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Ligament rupture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Lower limb fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Lumbar vertebral fracture | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Subdural haematoma | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Road traffic accident | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Blood pressure increased | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Oxygen saturation decreased | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Dehydration | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Arthralgia | 2/285 (0.7%) | 0/288 (0%) | 1/280 (0.4%) | 2/288 (0.7%) | 2/283 (0.7%) | 0/256 (0%) | 1/254 (0.4%) | 3/256 (1.2%) | 2/254 (0.8%) | 2/256 (0.8%) | ||||||||||
| Arthritis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Back pain | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Intervertebral disc disorder | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Intervertebral disc protrusion | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 1/288 (0.3%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Osteonecrosis | 5/285 (1.8%) | 2/288 (0.7%) | 9/280 (3.2%) | 2/288 (0.7%) | 2/283 (0.7%) | 1/256 (0.4%) | 2/254 (0.8%) | 1/256 (0.4%) | 5/254 (2%) | 2/256 (0.8%) | ||||||||||
| Rotator cuff syndrome | 0/285 (0%) | 0/288 (0%) | 2/280 (0.7%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 1/254 (0.4%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Spinal osteoarthritis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Spondylolisthesis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Synovial cyst | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 1/256 (0.4%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Bone disorder | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Intervertebral disc degeneration | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Knee deformity | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Muscular weakness | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pain in extremity | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Spinal column stenosis | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Synovitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Lumbar spinal stenosis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Osteoarthritis | 4/285 (1.4%) | 6/288 (2.1%) | 7/280 (2.5%) | 6/288 (2.1%) | 5/283 (1.8%) | 3/256 (1.2%) | 5/254 (2%) | 9/256 (3.5%) | 11/254 (4.3%) | 3/256 (1.2%) | ||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
| Adenocarcinoma | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Breast cancer | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Endometrial cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Gastric cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Hepatic neoplasm malignant | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Lung carcinoma cell type unspecified stage IV | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Metastases to lung | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Metastases to spine | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Ovarian cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pancreatic carcinoma | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pancreatic carcinoma | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Prostate cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Thyroid neoplasm | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Uterine cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Central nervous system lymphoma | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Colon cancer | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Lung adenocarcinoma | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Renal cancer | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Uterine leiomyoma | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pituitary tumour benign | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Aphasia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Cerebral ischaemia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Cerebrovascular accident | 1/285 (0.4%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 1/256 (0.4%) | ||||||||||
| Dizziness | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Ischaemic stroke | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Paralysis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Radiculopathy | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| VIIth nerve paralysis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | ||||||||||
| Cervical myelopathy | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Cervicobrachial syndrome | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Convulsion | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Headache | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Intracranial aneurysm | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Nerve root compression | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Paraesthesia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Transient ischaemic attack | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Depression | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Renal and urinary disorders | ||||||||||||||||||||
| Calculus ureteric | 0/285 (0%) | 1/288 (0.3%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Renal failure acute | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Bronchitis chronic | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Dyspnoea | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Pneumonitis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pneumothorax | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pulmonary embolism | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 1/288 (0.3%) | 0/283 (0%) | 2/256 (0.8%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Pulmonary oedema | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Asthma | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Atelectasis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Hyperhidrosis | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Rash | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 1/288 (0.3%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Aortic stenosis | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 1/254 (0.4%) | 0/256 (0%) | ||||||||||
| Deep vein thrombosis | 0/285 (0%) | 0/288 (0%) | 1/280 (0.4%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Hypertension | 1/285 (0.4%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 1/256 (0.4%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Peripheral ischaemia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg | Celecoxib 100 mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 201/285 (70.5%) | 205/288 (71.2%) | 201/280 (71.8%) | 202/288 (70.1%) | 188/283 (66.4%) | 195/256 (76.2%) | 181/254 (71.3%) | 182/256 (71.1%) | 187/254 (73.6%) | 170/256 (66.4%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Anaemia | 6/285 (2.1%) | 3/288 (1%) | 7/280 (2.5%) | 5/288 (1.7%) | 4/283 (1.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal pain upper | 2/285 (0.7%) | 1/288 (0.3%) | 5/280 (1.8%) | 6/288 (2.1%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Diarrhoea | 5/285 (1.8%) | 4/288 (1.4%) | 6/280 (2.1%) | 4/288 (1.4%) | 4/283 (1.4%) | 10/256 (3.9%) | 7/254 (2.8%) | 13/256 (5.1%) | 11/254 (4.3%) | 8/256 (3.1%) | ||||||||||
| Nausea | 8/285 (2.8%) | 2/288 (0.7%) | 8/280 (2.9%) | 1/288 (0.3%) | 3/283 (1.1%) | 6/256 (2.3%) | 1/254 (0.4%) | 4/256 (1.6%) | 5/254 (2%) | 9/256 (3.5%) | ||||||||||
| Dyspepsia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 4/256 (1.6%) | 2/254 (0.8%) | 6/256 (2.3%) | 1/254 (0.4%) | 4/256 (1.6%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Fatigue | 2/285 (0.7%) | 4/288 (1.4%) | 6/280 (2.1%) | 2/288 (0.7%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Oedema peripheral | 15/285 (5.3%) | 14/288 (4.9%) | 20/280 (7.1%) | 23/288 (8%) | 6/283 (2.1%) | 18/256 (7%) | 13/254 (5.1%) | 18/256 (7%) | 27/254 (10.6%) | 6/256 (2.3%) | ||||||||||
| Asthenia | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 0/256 (0%) | 0/254 (0%) | 6/256 (2.3%) | 2/254 (0.8%) | 2/256 (0.8%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Bronchitis | 8/285 (2.8%) | 5/288 (1.7%) | 5/280 (1.8%) | 2/288 (0.7%) | 4/283 (1.4%) | 7/256 (2.7%) | 6/254 (2.4%) | 5/256 (2%) | 9/254 (3.5%) | 6/256 (2.3%) | ||||||||||
| Influenza | 8/285 (2.8%) | 7/288 (2.4%) | 6/280 (2.1%) | 4/288 (1.4%) | 8/283 (2.8%) | 8/256 (3.1%) | 9/254 (3.5%) | 4/256 (1.6%) | 6/254 (2.4%) | 8/256 (3.1%) | ||||||||||
| Nasopharyngitis | 7/285 (2.5%) | 9/288 (3.1%) | 12/280 (4.3%) | 7/288 (2.4%) | 8/283 (2.8%) | 15/256 (5.9%) | 10/254 (3.9%) | 18/256 (7%) | 14/254 (5.5%) | 15/256 (5.9%) | ||||||||||
| Sinusitis | 6/285 (2.1%) | 6/288 (2.1%) | 6/280 (2.1%) | 4/288 (1.4%) | 11/283 (3.9%) | 8/256 (3.1%) | 6/254 (2.4%) | 5/256 (2%) | 6/254 (2.4%) | 10/256 (3.9%) | ||||||||||
| Upper respiratory tract infection | 11/285 (3.9%) | 11/288 (3.8%) | 14/280 (5%) | 10/288 (3.5%) | 14/283 (4.9%) | 11/256 (4.3%) | 8/254 (3.1%) | 8/256 (3.1%) | 13/254 (5.1%) | 16/256 (6.3%) | ||||||||||
| Urinary tract infection | 9/285 (3.2%) | 14/288 (4.9%) | 13/280 (4.6%) | 9/288 (3.1%) | 16/283 (5.7%) | 21/256 (8.2%) | 13/254 (5.1%) | 12/256 (4.7%) | 15/254 (5.9%) | 13/256 (5.1%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Fall | 5/285 (1.8%) | 10/288 (3.5%) | 12/280 (4.3%) | 14/288 (4.9%) | 8/283 (2.8%) | 13/256 (5.1%) | 8/254 (3.1%) | 12/256 (4.7%) | 11/254 (4.3%) | 7/256 (2.7%) | ||||||||||
| Joint sprain | 1/285 (0.4%) | 6/288 (2.1%) | 3/280 (1.1%) | 8/288 (2.8%) | 2/283 (0.7%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Joint injury | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 3/256 (1.2%) | 2/254 (0.8%) | 0/256 (0%) | 7/254 (2.8%) | 1/256 (0.4%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Blood creatine phosphokinase increased | 7/285 (2.5%) | 10/288 (3.5%) | 13/280 (4.6%) | 7/288 (2.4%) | 9/283 (3.2%) | 6/256 (2.3%) | 5/254 (2%) | 5/256 (2%) | 5/254 (2%) | 5/256 (2%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Arthralgia | 32/285 (11.2%) | 50/288 (17.4%) | 37/280 (13.2%) | 32/288 (11.1%) | 26/283 (9.2%) | 39/256 (15.2%) | 39/254 (15.4%) | 34/256 (13.3%) | 27/254 (10.6%) | 17/256 (6.6%) | ||||||||||
| Back pain | 16/285 (5.6%) | 12/288 (4.2%) | 9/280 (3.2%) | 12/288 (4.2%) | 12/283 (4.2%) | 15/256 (5.9%) | 9/254 (3.5%) | 11/256 (4.3%) | 12/254 (4.7%) | 8/256 (3.1%) | ||||||||||
| Joint effusion | 2/285 (0.7%) | 6/288 (2.1%) | 8/280 (2.9%) | 6/288 (2.1%) | 0/283 (0%) | 7/256 (2.7%) | 5/254 (2%) | 4/256 (1.6%) | 7/254 (2.8%) | 2/256 (0.8%) | ||||||||||
| Joint swelling | 8/285 (2.8%) | 17/288 (5.9%) | 9/280 (3.2%) | 11/288 (3.8%) | 5/283 (1.8%) | 14/256 (5.5%) | 10/254 (3.9%) | 9/256 (3.5%) | 6/254 (2.4%) | 2/256 (0.8%) | ||||||||||
| Muscle spasms | 9/285 (3.2%) | 6/288 (2.1%) | 9/280 (3.2%) | 7/288 (2.4%) | 6/283 (2.1%) | 5/256 (2%) | 2/254 (0.8%) | 7/256 (2.7%) | 5/254 (2%) | 4/256 (1.6%) | ||||||||||
| Musculoskeletal pain | 10/285 (3.5%) | 7/288 (2.4%) | 14/280 (5%) | 5/288 (1.7%) | 7/283 (2.5%) | 6/256 (2.3%) | 10/254 (3.9%) | 6/256 (2.3%) | 10/254 (3.9%) | 10/256 (3.9%) | ||||||||||
| Myalgia | 5/285 (1.8%) | 10/288 (3.5%) | 3/280 (1.1%) | 6/288 (2.1%) | 0/283 (0%) | 7/256 (2.7%) | 5/254 (2%) | 7/256 (2.7%) | 9/254 (3.5%) | 2/256 (0.8%) | ||||||||||
| Osteoarthritis | 12/285 (4.2%) | 11/288 (3.8%) | 12/280 (4.3%) | 14/288 (4.9%) | 7/283 (2.5%) | 12/256 (4.7%) | 16/254 (6.3%) | 17/256 (6.6%) | 12/254 (4.7%) | 13/256 (5.1%) | ||||||||||
| Pain in extremity | 9/285 (3.2%) | 22/288 (7.6%) | 9/280 (3.2%) | 14/288 (4.9%) | 7/283 (2.5%) | 10/256 (3.9%) | 13/254 (5.1%) | 12/256 (4.7%) | 16/254 (6.3%) | 11/256 (4.3%) | ||||||||||
| Neck pain | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 5/256 (2%) | 2/254 (0.8%) | 4/256 (1.6%) | 2/254 (0.8%) | 5/256 (2%) | ||||||||||
| Rotator cuff syndrome | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 2/256 (0.8%) | 4/254 (1.6%) | 2/256 (0.8%) | 6/254 (2.4%) | 0/256 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Carpal tunnel syndrome | 3/285 (1.1%) | 11/288 (3.8%) | 4/280 (1.4%) | 8/288 (2.8%) | 3/283 (1.1%) | 6/256 (2.3%) | 12/254 (4.7%) | 7/256 (2.7%) | 3/254 (1.2%) | 1/256 (0.4%) | ||||||||||
| Decreased vibratory sense | 8/285 (2.8%) | 1/288 (0.3%) | 2/280 (0.7%) | 2/288 (0.7%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Dizziness | 8/285 (2.8%) | 5/288 (1.7%) | 11/280 (3.9%) | 6/288 (2.1%) | 5/283 (1.8%) | 7/256 (2.7%) | 9/254 (3.5%) | 5/256 (2%) | 5/254 (2%) | 7/256 (2.7%) | ||||||||||
| Headache | 9/285 (3.2%) | 18/288 (6.3%) | 7/280 (2.5%) | 7/288 (2.4%) | 5/283 (1.8%) | 20/256 (7.8%) | 13/254 (5.1%) | 15/256 (5.9%) | 9/254 (3.5%) | 16/256 (6.3%) | ||||||||||
| Hypoaesthesia | 16/285 (5.6%) | 17/288 (5.9%) | 16/280 (5.7%) | 17/288 (5.9%) | 7/283 (2.5%) | 9/256 (3.5%) | 14/254 (5.5%) | 19/256 (7.4%) | 18/254 (7.1%) | 7/256 (2.7%) | ||||||||||
| Paraesthesia | 14/285 (4.9%) | 28/288 (9.7%) | 17/280 (6.1%) | 35/288 (12.2%) | 8/283 (2.8%) | 19/256 (7.4%) | 11/254 (4.3%) | 31/256 (12.1%) | 25/254 (9.8%) | 9/256 (3.5%) | ||||||||||
| Burning sensation | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 3/256 (1.2%) | 1/254 (0.4%) | 4/256 (1.6%) | 6/254 (2.4%) | 1/256 (0.4%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 2/285 (0.7%) | 6/288 (2.1%) | 2/280 (0.7%) | 3/288 (1%) | 1/283 (0.4%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Insomnia | 6/285 (2.1%) | 2/288 (0.7%) | 2/280 (0.7%) | 2/288 (0.7%) | 7/283 (2.5%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | 0/254 (0%) | 0/256 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Cough | 6/285 (2.1%) | 7/288 (2.4%) | 2/280 (0.7%) | 8/288 (2.8%) | 5/283 (1.8%) | 8/256 (3.1%) | 6/254 (2.4%) | 10/256 (3.9%) | 4/254 (1.6%) | 6/256 (2.3%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Rash | 3/285 (1.1%) | 5/288 (1.7%) | 7/280 (2.5%) | 6/288 (2.1%) | 5/283 (1.8%) | 4/256 (1.6%) | 4/254 (1.6%) | 6/256 (2.3%) | 6/254 (2.4%) | 2/256 (0.8%) | ||||||||||
| Pruritus | 0/285 (0%) | 0/288 (0%) | 0/280 (0%) | 0/288 (0%) | 0/283 (0%) | 3/256 (1.2%) | 2/254 (0.8%) | 5/256 (2%) | 1/254 (0.4%) | 6/256 (2.3%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Hypertension | 6/285 (2.1%) | 9/288 (3.1%) | 11/280 (3.9%) | 5/288 (1.7%) | 9/283 (3.2%) | 5/256 (2%) | 7/254 (2.8%) | 8/256 (3.1%) | 8/254 (3.1%) | 13/256 (5.1%) | ||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer, Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00809354
Other Study ID Numbers:
- A4091025
- 2008-004815-37
- OA CONTROLLED SAFETY STUDY
First Posted:
Dec 17, 2008
Last Update Posted:
Jun 24, 2021
Last Verified:
Jun 1, 2021