Tanezumab in Osteoarthritis Of The Hip
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00744471
Collaborator
(none)
627
99
4
20.8
6.3
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
627 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP.
Actual Study Start Date
:
Nov 17, 2008
Actual Primary Completion Date
:
Mar 15, 2010
Actual Study Completion Date
:
Aug 13, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tanezumab 10 mg Tanezumab 10 mg IV every 8 weeks |
Biological: tanezumab
Tanezumab 10 mg IV every 8 weeks
|
| Experimental: Tanezumab 5 mg Tanezumab 5mg IV every 8 weeks |
Biological: tanezumab
Tanezumab 5mg IV every 8 weeks
|
| Experimental: Tanezumab 2.5 mg Tanezumab 2.5 mg IV every 8 weeks. |
Biological: tanezumab
Tanezumab 2.5 mg IV every 8 weeks.
|
| Experimental: Placebo Placebo |
Biological: Placebo
Placebo to match tanezumab IV every 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline (Day 1), Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 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) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Secondary Outcome Measures
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 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) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 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) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 24]
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
- Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) [Week 2, 4, 8, 12, 16, 24]
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
- Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) [Week 2, 4, 8, 12 ,16, 24]
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
- Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
- Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
- Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12 ,16, 24]
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
- Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
- Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) [Baseline, Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
- Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) [Baseline, Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
- Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12 ,16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain.
- Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = worst possible pain, where higher scores indicating higher pain.
- Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 12, 24]
The SF-36 health survey was 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 score indicates highest level of functioning.
- Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 12, 24]
The SF-36 health survey was 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 score indicates highest level of functioning. These 8 domains were also summarized as summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for the each summary scores =0 to 100, where higher scores represented higher level of functioning. Higher summary scores indicated a better health related quality of life.
- Time to Discontinuation Due to Lack of Efficacy [Baseline up to Week 16]
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
- Percentage of Participants Who Used Rescue Medication [Week 2, 4, 8, 12 ,16, 24]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the particular study week were summarized.
- Duration of Rescue Medication Use [Week 2, 4, 8, 12, 16, 24]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participant used any of the rescue medication, during the specified week were summarized.
- Amount of Rescue Medication Taken [Week 2, 4, 8, 12, 16, 24]
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 32]
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 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events.
- Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 [Baseline, Week 2, 4, 6, 8, 12, 16, 24]
The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination 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 in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment.
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 hip according to ACR criteria with Kellgren-Lawrence x-ray grade of 2
-
Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for Hip injections, arthroplasty or replacement surgery
-
Pain level and function levels as required by the protocol at Screening and Baseline
-
Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study
-
Must agree to the contraceptive requirements of the protocol if applicable
-
Must agree to the treatment plan, scheduled visits, and procedures of the protocol
Exclusion Criteria:
-
Pregnancy
-
BMI greater than 39
-
Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Horizon Research Group | Mobile | Alabama | United States | 36608 |
| 2 | Arizona Arthritis & Rheumatology Associates, PC | Paradise Valley | Arizona | United States | 85253 |
| 3 | Pivotal Research Center | Peoria | Arizona | United States | 85381 |
| 4 | Arizona Research Center, Inc. | Phoenix | Arizona | United States | 85023 |
| 5 | Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC | Phoenix | Arizona | United States | 85028 |
| 6 | Arizona Arthritis & Rheumatology Associates, PC | Phoenix | Arizona | United States | 85037 |
| 7 | Quality of Life Medical & Research Center, LLC | Tucson | Arizona | United States | 85712 |
| 8 | Quality of Life Medical and Research Center | Tucson | Arizona | United States | 85712 |
| 9 | Tucson Orthopaedic Institute | Tucson | Arizona | United States | 85712 |
| 10 | St. Joseph's Mercy Clinic | Hot Springs | Arkansas | United States | 71913 |
| 11 | Providence Clinical Research | Burbank | California | United States | 91505 |
| 12 | Arthritis Medical Clinic of North County, Inc. | Escondido | California | United States | 92025 |
| 13 | Talbert Medical Group | Huntington Beach | California | United States | 92646 |
| 14 | Trinity Clinical Trials | Santa Ana | California | United States | 92701 |
| 15 | Clinical Research Center of Connecticut | Danbury | Connecticut | United States | 06810 |
| 16 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 17 | Javed Rheumatology Associates, Inc. | Newark | Delaware | United States | 19713 |
| 18 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
| 19 | Tampa Bay Medical Research Inc | Clearwater | Florida | United States | 33761 |
| 20 | Avail Clinical Research, LLC | DeLand | Florida | United States | 32720 |
| 21 | Avail Clinical Research | DeLand | Florida | United States | 32720 |
| 22 | Arthritis Associates of South Florida | Delray Beach | Florida | United States | 33484 |
| 23 | Delray Research Associates | Delray Beach | Florida | United States | 33484 |
| 24 | Westside Center for Clinical Research | Jacksonville | Florida | United States | 32205 |
| 25 | Adult Medicine Specialists | Longwood | Florida | United States | 32779 |
| 26 | Genesis Research International | Longwood | Florida | United States | 32779 |
| 27 | International Research Associates, LLC | Miami | Florida | United States | 33183 |
| 28 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
| 29 | The Arthritis Center | Palm Harbor | Florida | United States | 34684 |
| 30 | Advent Clinical Research Centers | Pinellas Park | Florida | United States | 33781 |
| 31 | Avivoclin Clinical Services | Port Orange | Florida | United States | 32127 |
| 32 | Accord Clinical Research, LLC | Port Orange | Florida | United States | 32129 |
| 33 | All Florida Orthopaedic Associates | Saint Petersburg | Florida | United States | 33703 |
| 34 | Palm Beach Research Center | West Palm Beach | Florida | United States | 33409 |
| 35 | Arthritis and Rheumatology of Georgia | Atlanta | Georgia | United States | 30342 |
| 36 | Laureate Clinical Reseach Group | Atlanta | Georgia | United States | 30342 |
| 37 | Early Family Practice Center | Fort Valley | Georgia | United States | 31030 |
| 38 | Northeast Georgia Diagnostic Clinic | Gainesville | Georgia | United States | 30501 |
| 39 | North Georgia Clinical Research | Marietta | Georgia | United States | 30060 |
| 40 | North Georgia Clinical Research | Woodstock | Georgia | United States | 30189 |
| 41 | North Georgia Internal medicine | Woodstock | Georgia | United States | 30189 |
| 42 | Sonora Clinical Research | Boise | Idaho | United States | 83702 |
| 43 | The Arthritis Center | Springfield | Illinois | United States | 62704 |
| 44 | American Health Network of IN, LLC | Fishers | Indiana | United States | 46038 |
| 45 | Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | United States | 46383 |
| 46 | Arthritis and Diabetes Clinic | Monroe | Louisiana | United States | 71203 |
| 47 | Maine Research Associates | Auburn | Maine | United States | 04210 |
| 48 | The Arthritis and Osteoporosis Center of Maryland | Frederick | Maryland | United States | 21702 |
| 49 | The Center for Rheumatology and Bone Research | Wheaton | Maryland | United States | 20902 |
| 50 | Mansfield Health Center | Mansfield | Massachusetts | United States | 02048 |
| 51 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01610 |
| 52 | Ann Arbor Clinical Research | Ann Arbor | Michigan | United States | 48103 |
| 53 | Rheumatology, PC | Kalamazoo | Michigan | United States | 49009 |
| 54 | MAPS Applied Research Center | Edina | Minnesota | United States | 55435 |
| 55 | Medical Advanced Pain Specialists | Edina | Minnesota | United States | 55435 |
| 56 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
| 57 | Quality Clinical Research, Inc. | Omaha | Nebraska | United States | 68114 |
| 58 | Clinical Research Consortium | Las Vegas | Nevada | United States | 89119 |
| 59 | Mirkil Medical | Las Vegas | Nevada | United States | 89119 |
| 60 | Office of Dr. Danka Michaels, MD | Las Vegas | Nevada | United States | 89128 |
| 61 | Comprehensive Clinical Research | Berlin | New Jersey | United States | 08009 |
| 62 | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | United States | 87102 |
| 63 | New Mexico Clinical Research & Osteoporosis Center, Incorporated | Albuquerque | New Mexico | United States | 87106 |
| 64 | Arthritis and Osteoporosis Center of Brooklyn Heights | Brooklyn | New York | United States | 11201 |
| 65 | The Medical Research Network, LLC | New York | New York | United States | 10128 |
| 66 | Prem C. Chatpar, MD, LLC | Plainview | New York | United States | 11803 |
| 67 | Office of Dr. Andrew Porges | Roslyn | New York | United States | 11576-1507 |
| 68 | Carolina Bone & Joint, P.A. | Charlotte | North Carolina | United States | 28210 |
| 69 | Pharmquest | Greensboro | North Carolina | United States | 27408 |
| 70 | Piedmont Medical Research Associates | Winston-Salem | North Carolina | United States | 27103 |
| 71 | Consultants for Clinical Research/Ohio GI and Liver Institute | Cincinnati | Ohio | United States | 45219 |
| 72 | Hilltop Physicians Inc, Hightop Medical Research Center | Cincinnati | Ohio | United States | 45224 |
| 73 | Southwest Rheumatology and Research Group, LLC | Middleburg Heights | Ohio | United States | 44130 |
| 74 | Pharmacotherapy Research Associates,Inc | Zanesville | Ohio | United States | 43701 |
| 75 | Health Research Institute | Oklahoma City | Oklahoma | United States | 73109 |
| 76 | EPIC Imaging West | Beaverton | Oregon | United States | 97008 |
| 77 | EPIC Imaging East | Portland | Oregon | United States | 97220 |
| 78 | Covance CRU, Inc. | Portland | Oregon | United States | 97239 |
| 79 | East Penn Rheumatology Associates, PC | Bethlehem | Pennsylvania | United States | 18015 |
| 80 | Brandywine Clinical Research | Downingtown | Pennsylvania | United States | 19335-2620 |
| 81 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 82 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 83 | Appalachian Medical Research Inc. | Johnson City | Tennessee | United States | 37604-1417 |
| 84 | Holston Medical Group | Kingsport | Tennessee | United States | 37660 |
| 85 | Capital Medical Clinic | Austin | Texas | United States | 78705 |
| 86 | Walter Chase MD | Austin | Texas | United States | 78705 |
| 87 | Radiant Research | Dallas | Texas | United States | 75231 |
| 88 | Rheumatic Disease Clinical Research Center | Houston | Texas | United States | 77004 |
| 89 | Pioneer Research Solutions | Houston | Texas | United States | 77008 |
| 90 | Pioneet Research Solutions, Inc | Houston | Texas | United States | 77036 |
| 91 | Clinical Investigations of Texas, LLC | Plano | Texas | United States | 75075 |
| 92 | Radiant Research San Antonio NE | San Antonio | Texas | United States | 78217 |
| 93 | Texas Arthritis Research Center, PA | San Antonio | Texas | United States | 78217 |
| 94 | Diagnostics Research Group | San Antonio | Texas | United States | 78229 |
| 95 | Sushma V. Gorrela, MD | Spring | Texas | United States | 77379 |
| 96 | Optimum Clinical Research | Salt Lake City | Utah | United States | 84102 |
| 97 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 98 | Internal Medicine Northwest, Frank S Baker Center | Tacoma | Washington | United States | 98405-4260 |
| 99 | Clinical Trials Northwest | Yakima | Washington | United States | 98902 |
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:
NCT00744471
Other Study ID Numbers:
- A4091014
- P3 OA HIP
First Posted:
Sep 1, 2008
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 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 | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Period Title: Overall Study | ||||
| STARTED | 156 | 156 | 158 | 157 |
| Treated | 155 | 155 | 154 | 157 |
| COMPLETED | 13 | 11 | 6 | 9 |
| NOT COMPLETED | 143 | 145 | 152 | 148 |
Baseline Characteristics
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Total of all reporting groups |
| Overall Participants | 155 | 155 | 154 | 157 | 621 |
| Age, Customized (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 44 years |
11
7.1%
|
8
5.2%
|
11
7.1%
|
6
3.8%
|
36
5.8%
|
| Between 45 and 64 years |
84
54.2%
|
86
55.5%
|
74
48.1%
|
82
52.2%
|
326
52.5%
|
| >= 65 years |
60
38.7%
|
61
39.4%
|
69
44.8%
|
69
43.9%
|
259
41.7%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
103
66.5%
|
101
65.2%
|
92
59.7%
|
88
56.1%
|
384
61.8%
|
| Male |
52
33.5%
|
54
34.8%
|
62
40.3%
|
69
43.9%
|
237
38.2%
|
Outcome Measures
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline (Day 1), Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat (mITT) analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Baseline |
7.26
(1.39)
|
7.20
(1.44)
|
7.24
(1.46)
|
7.33
(1.64)
|
| Change at Week 16 |
-1.65
(2.44)
|
-2.86
(2.73)
|
-3.35
(2.76)
|
-3.37
(2.80)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) Mean Difference |
| Estimated Value | -1.28 | |
| Confidence Interval |
(2-Sided) 95% -1.87 to -0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.69 | |
| Confidence Interval |
(2-Sided) 95% -2.28 to -1.10 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.75 | |
| Confidence Interval |
(2-Sided) 95% -2.34 to -1.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse 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 |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site.BOCF method used to impute missing values. "Overall Number of participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Baseline |
6.79
(1.56)
|
6.79
(1.63)
|
6.82
(1.70)
|
6.83
(1.83)
|
| Change at Week 16 |
-1.39
(2.25)
|
-2.54
(2.72)
|
-2.88
(2.70)
|
-2.96
(2.68)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -1.74 to -0.61 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.49 | |
| Confidence Interval |
(2-Sided) 95% -2.06 to -0.92 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.61 | |
| Confidence Interval |
(2-Sided) 95% -2.17 to -1.04 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Baseline |
3.47
(0.60)
|
3.55
(0.62)
|
3.51
(0.64)
|
3.46
(0.66)
|
| Change at Week 16 |
-0.34
(0.69)
|
-0.67
(0.87)
|
-0.80
(1.00)
|
-0.80
(0.94)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA model includes treatment as main effect, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to -0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-1.94
(2.08)
|
-3.32
(2.59)
|
-3.71
(2.53)
|
-3.30
(2.52)
|
| Change at Week 4 |
-1.92
(2.17)
|
-3.46
(2.64)
|
-3.99
(2.63)
|
-3.88
(2.74)
|
| Change at Week 8 |
-1.74
(2.33)
|
-2.76
(2.62)
|
-3.36
(2.60)
|
-3.70
(2.71)
|
| Change at Week 12 |
-1.81
(2.44)
|
-3.24
(2.89)
|
-3.67
(2.79)
|
-3.77
(2.98)
|
| Change at Week 24 |
-1.45
(2.43)
|
-2.54
(2.74)
|
-3.00
(2.80)
|
-3.06
(2.80)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.41 | |
| Confidence Interval |
(2-Sided) 95% -1.93 to -0.88 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.73 | |
| Confidence Interval |
(2-Sided) 95% -2.26 to -1.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA model includes treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.33 | |
| Confidence Interval |
(2-Sided) 95% -1.85 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.57 | |
| Confidence Interval |
(2-Sided) 95% -2.11 to -1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.03 | |
| Confidence Interval |
(2-Sided) 95% -2.57 to -1.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.95 | |
| Confidence Interval |
(2-Sided) 95% -2.50 to -1.41 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.09 | |
| Confidence Interval |
(2-Sided) 95% -1.65 to -0.53 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -2.20 to -1.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.00 | |
| Confidence Interval |
(2-Sided) 95% -2.56 to -1.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.49 | |
| Confidence Interval |
(2-Sided) 95% -2.10 to -0.88 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.85 | |
| Confidence Interval |
(2-Sided) 95% -2.46 to -1.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.97 | |
| Confidence Interval |
(2-Sided) 95% -2.57 to -1.37 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.16 | |
| Confidence Interval |
(2-Sided) 95% -1.75 to -0.56 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.52 | |
| Confidence Interval |
(2-Sided) 95% -2.12 to -0.92 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA model was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.60 | |
| Confidence Interval |
(2-Sided) 95% -2.20 to -1.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-1.94
(2.08)
|
-3.32
(2.59)
|
-3.71
(2.53)
|
-3.30
(2.52)
|
| Change at Week 4 |
-2.02
(2.18)
|
-3.55
(2.59)
|
-4.04
(2.60)
|
-4.04
(2.59)
|
| Change at Week 8 |
-1.86
(2.32)
|
-2.95
(2.50)
|
-3.52
(2.61)
|
-3.89
(2.69)
|
| Change at Week 12 |
-2.12
(2.48)
|
-3.58
(2.71)
|
-4.03
(2.67)
|
-4.35
(2.69)
|
| Change at Week 16 |
-2.05
(2.47)
|
-3.23
(2.59)
|
-3.66
(2.74)
|
-3.96
(2.61)
|
| Change at Week 24 |
-1.97
(2.50)
|
-3.16
(2.62)
|
-3.56
(2.74)
|
-3.77
(2.60)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.41 | |
| Confidence Interval |
(2-Sided) 95% -1.93 to -0.88 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.73 | |
| Confidence Interval |
(2-Sided) 95% -2.26 to -1.20 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.33 | |
| Confidence Interval |
(2-Sided) 95% -1.85 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.55 | |
| Confidence Interval |
(2-Sided) 95% -2.08 to -1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.99 | |
| Confidence Interval |
(2-Sided) 95% -2.52 to -1.46 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.01 | |
| Confidence Interval |
(2-Sided) 95% -2.54 to -1.48 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.17 | |
| Confidence Interval |
(2-Sided) 95% -1.71 to -0.63 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.66 | |
| Confidence Interval |
(2-Sided) 95% -2.21 to -1.12 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.06 | |
| Confidence Interval |
(2-Sided) 95% -2.60 to -1.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.55 | |
| Confidence Interval |
(2-Sided) 95% -2.11 to -0.99 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.88 | |
| Confidence Interval |
(2-Sided) 95% -2.45 to -1.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.26 | |
| Confidence Interval |
(2-Sided) 95% -2.82 to -1.70 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.27 | |
| Confidence Interval |
(2-Sided) 95% -1.82 to -0.71 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.59 | |
| Confidence Interval |
(2-Sided) 95% -2.15 to -1.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.96 | |
| Confidence Interval |
(2-Sided) 95% -2.51 to -1.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.29 | |
| Confidence Interval |
(2-Sided) 95% -1.85 to -0.72 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.58 | |
| Confidence Interval |
(2-Sided) 95% -2.15 to -1.01 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.83 | |
| Confidence Interval |
(2-Sided) 95% -2.40 to -1.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-1.56
(2.01)
|
-2.88
(2.53)
|
-3.32
(2.50)
|
-2.90
(2.46)
|
| Change at Week 4 |
-1.44
(1.99)
|
-3.06
(2.60)
|
-3.62
(2.43)
|
-3.40
(2.57)
|
| Change at Week 8 |
-1.33
(2.21)
|
-2.48
(2.66)
|
-2.95
(2.45)
|
-3.17
(2.61)
|
| Change at Week 12 |
-1.52
(2.19)
|
-2.86
(2.86)
|
-3.27
(2.71)
|
-3.39
(2.85)
|
| Change at Week 24 |
-1.27
(2.18)
|
-2.19
(2.65)
|
-2.62
(2.61)
|
-2.78
(2.67)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.31 | |
| Confidence Interval |
(2-Sided) 95% -1.83 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.71 | |
| Confidence Interval |
(2-Sided) 95% -2.23 to -1.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.32 | |
| Confidence Interval |
(2-Sided) 95% -1.83 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.60 | |
| Confidence Interval |
(2-Sided) 95% -2.12 to -1.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.12 | |
| Confidence Interval |
(2-Sided) 95% -2.64 to -1.60 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.94 | |
| Confidence Interval |
(2-Sided) 95% -2.46 to -1.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -1.72 to -0.64 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.64 | |
| Confidence Interval |
(2-Sided) 95% -2.18 to -1.09 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.89 | |
| Confidence Interval |
(2-Sided) 95% -2.43 to -1.35 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -1.93 to -0.77 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 12 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -1.73 | |
| Confidence Interval |
(2-Sided) 95% -2.31 to -1.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.30 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.89 | |
| Confidence Interval |
(2-Sided) 95% -2.47 to -1.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24 : ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 95% -1.52 to -0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -1.91 to -0.78 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24 :Analysis of Covariance (ANCOVA) was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.53 | |
| Confidence Interval |
(2-Sided) 95% -2.09 to -0.97 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-1.56
(2.01)
|
-2.88
(2.53)
|
-3.32
(2.50)
|
-2.90
(2.46)
|
| Change at Week 4 |
-1.51
(2.05)
|
-3.13
(2.59)
|
-3.67
(2.43)
|
-3.52
(2.48)
|
| Change at Week 8 |
-1.40
(2.24)
|
-2.66
(2.64)
|
-3.14
(2.44)
|
-3.35
(2.64)
|
| Change at Week 12 |
-1.61
(2.39)
|
-3.12
(2.82)
|
-3.58
(2.63)
|
-3.85
(2.68)
|
| Change at Week 16 |
-1.56
(2.41)
|
-2.83
(2.72)
|
-3.16
(2.72)
|
-3.42
(2.60)
|
| Change at Week 24 |
-1.46
(2.42)
|
-2.71
(2.71)
|
-3.09
(2.61)
|
-3.34
(2.56)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.31 | |
| Confidence Interval |
(2-Sided) 95% -1.83 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.71 | |
| Confidence Interval |
(2-Sided) 95% -2.23 to -1.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.32 | |
| Confidence Interval |
(2-Sided) 95% -1.83 to -0.80 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| 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 | -1.59 | |
| Confidence Interval |
(2-Sided) 95% -2.10 to -1.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.10 | |
| Confidence Interval |
(2-Sided) 95% -2.61 to -1.59 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.00 | |
| Confidence Interval |
(2-Sided) 95% -2.51 to -1.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.29 | |
| Confidence Interval |
(2-Sided) 95% -1.83 to -0.76 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.72 | |
| Confidence Interval |
(2-Sided) 95% -2.26 to -1.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -1.99 | |
| Confidence Interval |
(2-Sided) 95% -2.53 to -1.46 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.56 | |
| Confidence Interval |
(2-Sided) 95% -2.11 to -1.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean difference |
| Estimated Value | -1.93 | |
| Confidence Interval |
(2-Sided) 95% -2.49 to -1.37 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -2.28 | |
| Confidence Interval |
(2-Sided) 95% -2.83 to -1.72 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.31 | |
| Confidence Interval |
(2-Sided) 95% -1.87 to -0.75 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.58 | |
| Confidence Interval |
(2-Sided) 95% -2.14 to -1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.29 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.92 | |
| Confidence Interval |
(2-Sided) 95% -2.47 to -1.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.30 | |
| Confidence Interval |
(2-Sided) 95% -1.86 to -0.74 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.61 | |
| Confidence Interval |
(2-Sided) 95% -2.17 to -1.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | -1.91 | |
| Confidence Interval |
(2-Sided) 95% -2.47 to -1.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.28 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-0.41
(0.83)
|
-0.83
(0.94)
|
-1.08
(1.02)
|
-0.81
(0.92)
|
| Change at Week 4 |
-0.44
(0.79)
|
-0.93
(0.88)
|
-1.16
(0.96)
|
-0.97
(0.98)
|
| Change at Week 8 |
-0.43
(0.86)
|
-0.65
(0.93)
|
-0.93
(1.03)
|
-0.86
(0.94)
|
| Change at Week 12 |
-0.41
(0.76)
|
-0.78
(0.93)
|
-1.03
(1.05)
|
-0.92
(0.96)
|
| Change at Week 24 |
-0.36
(0.72)
|
-0.61
(0.84)
|
-0.78
(1.00)
|
-0.60
(0.89)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.64 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.69 | |
| Confidence Interval |
(2-Sided) 95% -0.88 to -0.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.55 | |
| Confidence Interval |
(2-Sided) 95% -0.73 to -0.36 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.054 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.19 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.00 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.68 to -0.29 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.45 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.15 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.61 | |
| Confidence Interval |
(2-Sided) 95% -0.81 to -0.40 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.53 | |
| Confidence Interval |
(2-Sided) 95% -0.73 to -0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.008 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.26 | |
| Confidence Interval |
(2-Sided) 95% -0.45 to -0.07 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.012 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.43 to -0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. "Overall Number of Participants Analyzed" = participants evaluable for this outcome measure. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 150 | 150 | 155 |
| Change at Week 2 |
-0.41
(0.83)
|
-0.83
(0.94)
|
-1.08
(1.02)
|
-0.81
(0.92)
|
| Change at Week 4 |
-0.45
(0.81)
|
-0.95
(0.88)
|
-1.17
(0.97)
|
-1.03
(0.99)
|
| Change at Week 8 |
-0.46
(0.90)
|
-0.73
(0.95)
|
-0.96
(1.04)
|
-0.90
(0.96)
|
| Change at Week 12 |
-0.44
(0.90)
|
-0.87
(0.99)
|
-1.14
(1.05)
|
-1.01
(1.00)
|
| Change at Week 16 |
-0.38
(0.86)
|
-0.76
(0.95)
|
-0.89
(1.05)
|
-0.88
(0.99)
|
| Change at Week 24 |
-0.42
(0.90)
|
-0.71
(0.95)
|
-0.90
(1.08)
|
-0.74
(0.98)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.18 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.64 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.45 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 2: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.41 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -0.87 to -0.50 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 4: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.76 to -0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.022 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.43 to -0.03 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.47 | |
| Confidence Interval |
(2-Sided) 95% -0.67 to -0.27 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 8: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.65 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 10
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.60 to -0.19 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 11
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -0.88 to -0.47 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 12
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 12: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.59 | |
| Confidence Interval |
(2-Sided) 95% -0.79 to -0.39 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 13
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.33 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 14
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -0.68 to -0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 15
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 16: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.51 | |
| Confidence Interval |
(2-Sided) 95% -0.71 to -0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 16
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 17
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 5 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.66 to -0.25 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
Statistical Analysis 18
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 10 mg |
|---|---|---|
| Comments | Change at Week 24: ANCOVA was performed with treatment as main effect, baseline value, as a covariate, and study site as a random effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | P-value is based on ANCOVA from pairwise comparisons. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.33 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to -0.13 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.10 |
|
| Estimation Comments | ||
| Title | Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty). |
| Time Frame | Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
45.5
29.4%
|
68.7
44.3%
|
80.0
51.9%
|
67.7
43.1%
|
| Week 4 |
45.5
29.4%
|
71.3
46%
|
79.3
51.5%
|
74.8
47.6%
|
| Week 8 |
43.5
28.1%
|
60.7
39.2%
|
70.7
45.9%
|
71.0
45.2%
|
| Week 12 |
39.6
25.5%
|
63.3
40.8%
|
70.0
45.5%
|
66.5
42.4%
|
| Week 16 |
35.1
22.6%
|
57.3
37%
|
65.3
42.4%
|
65.8
41.9%
|
| Week 24 |
30.5
19.7%
|
50.7
32.7%
|
62.0
40.3%
|
58.7
37.4%
|
| Title | Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty). |
| Time Frame | Week 2, 4, 8, 12 ,16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
45.5
29.4%
|
68.7
44.3%
|
80.0
51.9%
|
67.7
43.1%
|
| Week 4 |
48.1
31%
|
73.3
47.3%
|
81.3
52.8%
|
78.7
50.1%
|
| Week 8 |
47.4
30.6%
|
66.7
43%
|
75.3
48.9%
|
75.5
48.1%
|
| Week 12 |
50.0
32.3%
|
74.0
47.7%
|
78.0
50.6%
|
78.1
49.7%
|
| Week 16 |
48.1
31%
|
68.7
44.3%
|
72.0
46.8%
|
77.4
49.3%
|
| Week 24 |
46.1
29.7%
|
66.7
43%
|
73.3
47.6%
|
74.2
47.3%
|
| Title | Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint 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 is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2: >=30% reduction |
38.3
24.7%
|
64.2
41.4%
|
70.7
45.9%
|
58.3
37.1%
|
| Week 2: >=50% reduction |
26.0
16.8%
|
49.0
31.6%
|
50.7
32.9%
|
44.2
28.2%
|
| Week 4: >=30% reduction |
37.7
24.3%
|
65.6
42.3%
|
72.0
46.8%
|
70.5
44.9%
|
| Week 4: >=50% reduction |
23.4
15.1%
|
50.3
32.5%
|
59.3
38.5%
|
56.4
35.9%
|
| Week 8: >=30% reduction |
36.4
23.5%
|
59.6
38.5%
|
66.0
42.9%
|
68.4
43.6%
|
| Week 8: >= 50% reduction |
22.1
14.3%
|
40.4
26.1%
|
48.7
31.6%
|
52.9
33.7%
|
| Week 12: >= 30% reduction |
37.7
24.3%
|
59.6
38.5%
|
65.3
42.4%
|
64.7
41.2%
|
| Week 12: >= 50% reduction |
26.0
16.8%
|
49.0
31.6%
|
53.3
34.6%
|
59.0
37.6%
|
| Week 16: >= 30% reduction |
32.5
21%
|
56.3
36.3%
|
63.3
41.1%
|
61.5
39.2%
|
| Week 16: >= 50% reduction |
26.0
16.8%
|
39.7
25.6%
|
50.7
32.9%
|
46.2
29.4%
|
| Week 24: >= 30% reduction |
27.9
18%
|
47.7
30.8%
|
57.3
37.2%
|
57.1
36.4%
|
| Week 24: >= 50% reduction |
19.5
12.6%
|
37.1
23.9%
|
46.0
29.9%
|
44.2
28.2%
|
| Title | Percentage of Participants With at Least 30 Percent (%), and 50% 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 questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1021. LOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 >= 30% Reduction |
38.3
24.7%
|
64.2
41.4%
|
70.7
45.9%
|
58.3
37.1%
|
| Week 2 >= 50% Reduction |
26.0
16.8%
|
49.0
31.6%
|
50.7
32.9%
|
44.2
28.2%
|
| Week 4 >= 30% Reduction |
39.0
25.2%
|
66.9
43.2%
|
74.0
48.1%
|
73.7
46.9%
|
| Week 4 >= 50% Reduction |
24.7
15.9%
|
51.7
33.4%
|
59.3
38.5%
|
57.7
36.8%
|
| Week 8 >= 30% Reduction |
38.3
24.7%
|
63.6
41%
|
69.3
45%
|
71.8
45.7%
|
| Week 8 >= 50% Reduction |
22.7
14.6%
|
41.1
26.5%
|
50.0
32.5%
|
54.5
34.7%
|
| Week 12 >= 30% Reduction |
44.8
28.9%
|
67.5
43.5%
|
72.7
47.2%
|
75.6
48.2%
|
| Week 12 >= 50% Reduction |
27.9
18%
|
52.3
33.7%
|
58.0
37.7%
|
66.0
42%
|
| Week 16 >= 30% Reduction |
41.6
26.8%
|
64.9
41.9%
|
69.3
45%
|
72.4
46.1%
|
| Week 16 >= 50% Reduction |
28.6
18.5%
|
43.7
28.2%
|
54.7
35.5%
|
53.2
33.9%
|
| Week 24 >= 30% Reduction |
39.6
25.5%
|
60.9
39.3%
|
68.0
44.2%
|
71.2
45.4%
|
| Week 24 >= 50% Reduction |
23.4
15.1%
|
43.7
28.2%
|
52.7
34.2%
|
51.9
33.1%
|
| Title | Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported. |
| Time Frame | Baseline, Week 2, 4, 8, 12 ,16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
9.7
6.3%
|
24.0
15.5%
|
32.0
20.8%
|
24.5
15.6%
|
| Week 4 |
10.4
6.7%
|
25.3
16.3%
|
34.0
22.1%
|
31.6
20.1%
|
| Week 8 |
10.4
6.7%
|
15.3
9.9%
|
27.3
17.7%
|
27.1
17.3%
|
| Week 12 |
11.7
7.5%
|
22.0
14.2%
|
28.7
18.6%
|
29.7
18.9%
|
| Week 16 |
7.1
4.6%
|
14.7
9.5%
|
20.0
13%
|
27.7
17.6%
|
| Week 24 |
8.4
5.4%
|
15.3
9.9%
|
20.7
13.4%
|
18.7
11.9%
|
| Title | Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. LOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
9.7
6.3%
|
24.0
15.5%
|
32.0
20.8%
|
24.5
15.6%
|
| Week 4 |
10.4
6.7%
|
26.0
16.8%
|
34.7
22.5%
|
34.2
21.8%
|
| Week 8 |
11.0
7.1%
|
18.0
11.6%
|
28.0
18.2%
|
28.4
18.1%
|
| Week 12 |
12.3
7.9%
|
25.3
16.3%
|
31.3
20.3%
|
32.9
21%
|
| Week 16 |
8.4
5.4%
|
18.7
12.1%
|
23.3
15.1%
|
30.3
19.3%
|
| Week 24 |
9.7
6.3%
|
19.3
12.5%
|
25.3
16.4%
|
23.2
14.8%
|
| Title | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Greater than (>) 0% |
44.8
28.9%
|
68.2
44%
|
78.7
51.1%
|
72.4
46.1%
|
| >=10% |
40.9
26.4%
|
64.9
41.9%
|
73.3
47.6%
|
70.5
44.9%
|
| >=20% |
36.4
23.5%
|
58.9
38%
|
66.7
43.3%
|
67.3
42.9%
|
| >=30% |
32.5
21%
|
56.3
36.3%
|
63.3
41.1%
|
61.5
39.2%
|
| >=40% |
29.2
18.8%
|
50.3
32.5%
|
54.7
35.5%
|
53.2
33.9%
|
| >=50% |
26.0
16.8%
|
39.7
25.6%
|
50.7
32.9%
|
46.2
29.4%
|
| >=60% |
19.5
12.6%
|
35.8
23.1%
|
43.3
28.1%
|
39.7
25.3%
|
| >=70% |
13.6
8.8%
|
28.5
18.4%
|
36.7
23.8%
|
35.3
22.5%
|
| >=80% |
11.0
7.1%
|
21.9
14.1%
|
25.3
16.4%
|
30.1
19.2%
|
| >=90% |
4.5
2.9%
|
13.2
8.5%
|
18.0
11.7%
|
20.5
13.1%
|
| Title | Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported. |
| Time Frame | Baseline, Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. LOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| >0% |
79.2
51.1%
|
87.4
56.4%
|
89.3
58%
|
93.6
59.6%
|
| >=10% |
63.6
41%
|
81.5
52.6%
|
82.0
53.2%
|
89.7
57.1%
|
| >=20% |
50.6
32.6%
|
70.2
45.3%
|
74.7
48.5%
|
81.4
51.8%
|
| >=30% |
41.6
26.8%
|
64.9
41.9%
|
69.3
45%
|
72.4
46.1%
|
| >=40% |
34.4
22.2%
|
57.0
36.8%
|
59.3
38.5%
|
61.5
39.2%
|
| >=50% |
28.6
18.5%
|
43.7
28.2%
|
54.7
35.5%
|
53.2
33.9%
|
| >=60% |
21.4
13.8%
|
37.7
24.3%
|
47.3
30.7%
|
45.5
29%
|
| >=70% |
14.3
9.2%
|
29.1
18.8%
|
40.7
26.4%
|
40.4
25.7%
|
| >=80% |
11.0
7.1%
|
21.9
14.1%
|
28.0
18.2%
|
34.6
22%
|
| >=90% |
4.5
2.9%
|
13.2
8.5%
|
20.0
13%
|
23.1
14.7%
|
| Title | Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline |
6.61
(1.86)
|
6.44
(1.89)
|
6.71
(1.93)
|
6.55
(1.96)
|
| Change at Week 2 |
-1.24
(1.97)
|
-1.89
(2.40)
|
-2.51
(2.51)
|
-2.03
(2.57)
|
| Change at Week 4 |
-1.16
(2.07)
|
-2.44
(2.42)
|
-3.10
(2.55)
|
-2.65
(2.65)
|
| Change at Week 8 |
-0.99
(2.00)
|
-2.00
(2.37)
|
-2.50
(2.48)
|
-2.44
(2.59)
|
| Change at Week 12 |
-1.34
(2.15)
|
-2.19
(2.58)
|
-2.84
(2.62)
|
-2.83
(2.82)
|
| Change at Week 16 |
-1.18
(2.06)
|
-2.02
(2.40)
|
-2.39
(2.55)
|
-2.56
(2.64)
|
| Change at Week 24 |
-0.97
(1.90)
|
-1.55
(2.29)
|
-2.24
(2.61)
|
-2.12
(2.59)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint. |
| Time Frame | Baseline, Week 2, 4, 8, 12 ,16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline |
7.18
(1.65)
|
7.17
(1.69)
|
7.02
(2.01)
|
7.23
(1.96)
|
| Change at Week 2 |
-1.69
(2.25)
|
-3.13
(2.67)
|
-3.47
(3.02)
|
-3.32
(3.04)
|
| Change at Week 4 |
-1.51
(2.25)
|
-3.29
(2.72)
|
-3.80
(2.89)
|
-3.82
(3.00)
|
| Change at Week 8 |
-1.34
(2.41)
|
-2.61
(2.69)
|
-3.17
(3.08)
|
-3.46
(2.97)
|
| Change at Week 12 |
-1.52
(2.30)
|
-3.05
(2.95)
|
-3.60
(3.13)
|
-3.78
(3.19)
|
| Change at Week 16 |
-1.39
(2.32)
|
-2.54
(2.76)
|
-3.09
(3.00)
|
-3.33
(2.99)
|
| Change at Week 24 |
-1.32
(2.35)
|
-2.30
(2.77)
|
-2.93
(3.08)
|
-3.16
(3.04)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline |
7.08
(1.39)
|
7.05
(1.42)
|
7.03
(1.57)
|
7.13
(1.63)
|
| Change at Week 2 |
-1.73
(1.97)
|
-3.13
(2.50)
|
-3.50
(2.57)
|
-3.17
(2.55)
|
| Change at Week 4 |
-1.62
(2.02)
|
-3.27
(2.54)
|
-3.80
(2.53)
|
-3.70
(2.65)
|
| Change at Week 8 |
-1.47
(2.22)
|
-2.63
(2.56)
|
-3.17
(2.57)
|
-3.45
(2.66)
|
| Change at Week 12 |
-1.62
(2.23)
|
-3.05
(2.82)
|
-3.51
(2.78)
|
-3.65
(2.93)
|
| Change at Week 16 |
-1.48
(2.28)
|
-2.65
(2.65)
|
-3.10
(2.72)
|
-3.22
(2.73)
|
| Change at Week 24 |
-1.35
(2.28)
|
-2.34
(2.66)
|
-2.85
(2.72)
|
-3.00
(2.72)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline |
7.26
(1.66)
|
7.21
(1.65)
|
7.25
(1.61)
|
7.32
(1.76)
|
| Change at Week 2 |
-1.83
(2.39)
|
-3.31
(2.81)
|
-3.79
(2.71)
|
-3.33
(2.54)
|
| Change at Week 4 |
-1.96
(2.38)
|
-3.40
(2.73)
|
-4.01
(2.83)
|
-3.75
(2.87)
|
| Change at Week 8 |
-1.71
(2.55)
|
-2.84
(2.73)
|
-3.25
(2.77)
|
-3.45
(2.71)
|
| Change at Week 12 |
-1.76
(2.51)
|
-3.13
(2.97)
|
-3.65
(2.90)
|
-3.59
(2.96)
|
| Change at Week 16 |
-1.56
(2.43)
|
-2.73
(2.91)
|
-3.29
(2.98)
|
-3.21
(2.81)
|
| Change at Week 24 |
-1.44
(2.43)
|
-2.45
(2.78)
|
-2.95
(2.93)
|
-2.94
(2.80)
|
| Title | Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = worst possible pain, where higher scores indicating higher pain. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. BOCF method used to impute missing values. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline |
7.99
(1.46)
|
7.94
(1.51)
|
7.83
(1.59)
|
7.89
(1.81)
|
| Change at Week 2 |
-1.88
(2.15)
|
-3.42
(2.62)
|
-3.89
(2.85)
|
-3.35
(2.71)
|
| Change at Week 4 |
-1.84
(2.26)
|
-3.59
(2.82)
|
-4.11
(2.87)
|
-3.82
(3.03)
|
| Change at Week 8 |
-1.64
(2.32)
|
-2.87
(2.84)
|
-3.46
(2.92)
|
-3.59
(3.05)
|
| Change at Week 12 |
-1.75
(2.49)
|
-3.39
(3.10)
|
-3.80
(3.08)
|
-3.72
(3.23)
|
| Change at Week 16 |
-1.56
(2.50)
|
-2.95
(3.00)
|
-3.41
(3.11)
|
-3.21
(3.03)
|
| Change at Week 24 |
-1.45
(2.46)
|
-2.54
(2.92)
|
-2.98
(3.04)
|
-2.92
(3.03)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The SF-36 health survey was 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 score indicates highest level of functioning. |
| Time Frame | Baseline, Week 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Baseline: General health |
64.81
(18.81)
|
67.04
(18.12)
|
63.74
(18.60)
|
64.26
(19.29)
|
| Baseline: Physical Function |
30.56
(19.51)
|
29.66
(20.35)
|
30.78
(19.69)
|
29.48
(19.29)
|
| Baseline: Role Physical |
39.25
(24.74)
|
36.96
(24.78)
|
38.83
(25.33)
|
38.47
(23.86)
|
| Baseline: Bodily Pain |
29.70
(13.96)
|
29.66
(14.56)
|
29.73
(15.78)
|
31.25
(16.27)
|
| Baseline: Vitality |
47.28
(21.28)
|
49.42
(20.93)
|
48.04
(20.70)
|
46.85
(22.81)
|
| Baseline: Social Function |
64.37
(27.11)
|
66.67
(25.32)
|
63.67
(28.76)
|
66.61
(28.39)
|
| Baseline: Role Emotional |
63.47
(30.57)
|
68.94
(28.34)
|
67.22
(30.86)
|
68.76
(30.26)
|
| Baseline: Mental Health |
72.63
(18.70)
|
74.30
(17.76)
|
73.90
(18.80)
|
73.32
(19.63)
|
| Change at Week 12:General health |
2.07
(9.34)
|
4.01
(12.61)
|
8.03
(14.24)
|
5.27
(13.14)
|
| Change at Week12:Physical Function |
6.01
(15.12)
|
15.01
(21.38)
|
18.52
(25.16)
|
18.91
(24.96)
|
| Change at Week 12: Role Physical |
7.67
(20.91)
|
16.88
(23.77)
|
22.83
(28.70)
|
18.99
(27.10)
|
| Change at Week 12: Bodily Pain |
10.42
(17.62)
|
17.97
(22.08)
|
25.23
(25.48)
|
22.87
(26.10)
|
| Change at Week 12: Vitality |
5.24
(14.14)
|
8.13
(15.66)
|
10.79
(19.82)
|
7.86
(20.03)
|
| Change at Week 12:Social Function |
5.52
(18.91)
|
10.25
(22.16)
|
12.08
(24.89)
|
10.08
(24.88)
|
| Change at Week 12:Role emotional |
4.44
(21.01)
|
8.33
(19.14)
|
11.72
(26.93)
|
9.68
(23.43)
|
| Change at Week 12: Mental Health |
3.77
(11.86)
|
4.07
(13.44)
|
5.73
(15.87)
|
2.55
(16.15)
|
| Change at Week 24:General health |
1.69
(11.03)
|
3.64
(10.99)
|
4.70
(12.88)
|
4.17
(13.82)
|
| Change at Week 24:Physical Function |
6.24
(16.12)
|
9.97
(16.87)
|
12.99
(22.00)
|
14.25
(21.60)
|
| Change at Week 24: Role Physical |
7.55
(16.05)
|
12.04
(20.21)
|
13.88
(26.31)
|
13.63
(22.54)
|
| Change at Week 24: Bodily Pain |
9.16
(17.76)
|
11.39
(18.79)
|
15.91
(21.97)
|
14.94
(21.55)
|
| Change at Week 24: Vitality |
3.77
(12.01)
|
6.46
(14.63)
|
6.83
(17.58)
|
6.61
(15.31)
|
| Change at Week 24:Social Function |
3.73
(18.25)
|
6.92
(19.62)
|
8.83
(22.74)
|
5.73
(19.60)
|
| Change at Week 24:Role Emotional |
3.30
(17.19)
|
7.72
(17.80)
|
7.56
(23.81)
|
5.97
(22.19)
|
| Change at Week 24: Mental Health |
1.40
(11.34)
|
3.53
(13.01)
|
1.73
(13.94)
|
1.60
(15.06)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | The SF-36 health survey was 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 score indicates highest level of functioning. These 8 domains were also summarized as summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for the each summary scores =0 to 100, where higher scores represented higher level of functioning. Higher summary scores indicated a better health related quality of life. |
| Time Frame | Baseline, Week 12, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. BOCF method was used to impute missing values. Here, 'Overall Number of Participants Analyzed', signified number of participants evaluable for this outcome measure for respective reporting groups. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 153 | 150 | 150 | 155 |
| Baseline: MCA |
-0.03
(1.20)
|
0.18
(1.15)
|
0.06
(1.26)
|
0.11
(1.29)
|
| Baseline: PCA |
-1.90
(0.72)
|
-1.99
(0.82)
|
-1.96
(0.77)
|
-1.97
(0.76)
|
| Change at Week 12: MCA |
0.15
(0.73)
|
0.19
(0.81)
|
0.26
(1.02)
|
0.10
(0.96)
|
| Change at Week 12: PCA |
0.29
(0.64)
|
0.66
(0.90)
|
0.89
(1.05)
|
0.84
(1.02)
|
| Change at Week 24: MCA |
0.04
(0.69)
|
0.20
(0.70)
|
0.12
(0.88)
|
0.04
(0.87)
|
| Change at Week 24: PCA |
0.31
(0.63)
|
0.42
(0.73)
|
0.60
(0.91)
|
0.61
(0.86)
|
| Title | Time to Discontinuation Due to Lack of Efficacy |
|---|---|
| Description | Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. |
| Time Frame | Baseline up to Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo). |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 155 | 155 | 154 | 157 |
| Median (Full Range) [Days] |
NA
|
NA
|
NA
|
NA
|
| Title | Percentage of Participants Who Used Rescue Medication |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the particular study week were summarized. |
| Time Frame | Week 2, 4, 8, 12 ,16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded at a study site. LOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
46.1
29.7%
|
37.1
23.9%
|
36.1
23.4%
|
37.4
23.8%
|
| Week 4 |
45.8
29.5%
|
26.5
17.1%
|
23.6
15.3%
|
23.1
14.7%
|
| Week 8 |
30.7
19.8%
|
26.5
17.1%
|
22.1
14.4%
|
29.5
18.8%
|
| Week 12 |
25.5
16.5%
|
22.5
14.5%
|
15.4
10%
|
20.5
13.1%
|
| Week 16 |
23.5
15.2%
|
24.5
15.8%
|
24.2
15.7%
|
16.7
10.6%
|
| Week 24 |
23.5
15.2%
|
25.8
16.6%
|
22.8
14.8%
|
24.4
15.5%
|
| Title | Duration of Rescue Medication Use |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participant used any of the rescue medication, during the specified week were summarized. |
| Time Frame | Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method was used to impute missing values. Here, 'Number Analyzed', signified number of participants evaluable at specified time points. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 154 | 151 | 150 | 156 |
| Week 2 |
2.0
|
1.0
|
1.0
|
1.0
|
| Week 4 |
2.0
|
1.0
|
0.0
|
0.0
|
| Week 8 |
1.0
|
1.0
|
0.0
|
0.0
|
| Week 12 |
0.0
|
0.0
|
0.0
|
0.0
|
| Week 16 |
0.0
|
0.0
|
0.0
|
0.0
|
| Title | Amount of Rescue Medication Taken |
|---|---|
| Description | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized. |
| Time Frame | Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set: All randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo), except those who were potentially unblinded at study site. LOCF method was used to impute missing values. Here 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 153 | 151 | 150 | 156 |
| Week 2 |
3917.76
(4859.09)
|
3205.30
(4485.63)
|
3346.94
(5405.67)
|
3306.45
(4470.46)
|
| Week 4 |
3676.47
(4774.68)
|
2437.09
(3932.47)
|
2148.65
(4331.68)
|
1919.87
(3183.88)
|
| Week 8 |
3163.40
(4984.13)
|
2811.26
(5086.17)
|
2372.48
(5138.01)
|
2298.08
(3592.46)
|
| Week 12 |
2683.01
(5597.74)
|
2304.64
(4477.34)
|
2093.96
(5141.37)
|
1910.26
(3648.90)
|
| Week 16 |
2366.01
(4771.42)
|
2350.99
(4710.91)
|
2382.55
(5197.90)
|
1666.67
(3542.07)
|
| Week 24 |
2496.73
(5120.42)
|
2274.83
(4808.22)
|
2684.56
(5787.73)
|
1996.79
(3717.65)
|
| 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 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events. |
| Time Frame | Baseline up to Week 32 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 155 | 155 | 154 | 157 |
| AEs |
68
43.9%
|
90
58.1%
|
84
54.5%
|
89
56.7%
|
| SAEs |
6
3.9%
|
5
3.2%
|
7
4.5%
|
6
3.8%
|
| Title | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24 |
|---|---|
| Description | The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination 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 in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment. |
| Time Frame | Baseline, Week 2, 4, 6, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here 'Number Analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively. |
| Arm/Group Title | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. |
| Measure Participants | 155 | 155 | 154 | 157 |
| Change at Week 2 |
-0.09
(1.44)
|
-0.22
(1.92)
|
-0.21
(1.03)
|
-0.10
(1.40)
|
| Change at Week 4 |
-0.03
(2.29)
|
0.03
(2.32)
|
-0.38
(1.16)
|
-0.45
(1.52)
|
| Change at Week 8 |
-0.23
(2.04)
|
-0.45
(1.74)
|
-0.38
(1.60)
|
-0.35
(1.71)
|
| Change at Week 12 |
-0.23
(1.16)
|
-0.40
(1.96)
|
-0.41
(1.71)
|
-0.47
(1.45)
|
| Change at Week 16 |
0.07
(1.48)
|
-0.33
(2.51)
|
-0.36
(1.63)
|
-0.40
(2.07)
|
| Change at Week 24 |
-0.06
(0.83)
|
-0.17
(1.72)
|
-0.46
(1.63)
|
-0.20
(1.59)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Participants may have experienced both nonserious and SAE during study. Cases of osteonecrosis (ON) reported in this and other studies of this program, 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 | Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | ||||
| Arm/Group Description | Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 2.5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16. | ||||
All Cause Mortality |
||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/155 (3.9%) | 5/155 (3.2%) | 7/154 (4.5%) | 6/157 (3.8%) | ||||
| Cardiac disorders | ||||||||
| Atrial flutter | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Cardiac arrest | 0/155 (0%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Cardiopulmonary failure | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Coronary artery disease | 0/155 (0%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Duodenal ulcer | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Gastrointestinal haemorrhage | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Gastrointestinal oedema | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Gastrooesophageal reflux disease | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Intestinal obstruction | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Small intestinal obstruction | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Umbilical hernia | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| General disorders | ||||||||
| Oedema peripheral | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/155 (0%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Infections and infestations | ||||||||
| Cellulitis | 0/155 (0%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Periorbital cellulitis | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Pneumonia | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Appendicitis perforated | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Fall | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Thoracic vertebral fracture | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Fistula | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Intervertebral disc protrusion | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Osteonecrosis | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 1/157 (0.6%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Basal cell carcinoma | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Colon cancer | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Lung neoplasm malignant | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
| Malignant melanoma in situ | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Mesothelioma | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Synovial sarcoma | 0/155 (0%) | 0/155 (0%) | 0/154 (0%) | 1/157 (0.6%) | ||||
| Nervous system disorders | ||||||||
| Haemorrhage intracranial | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Syncope | 0/155 (0%) | 0/155 (0%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pleural effusion | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Actinic keratosis | 1/155 (0.6%) | 0/155 (0%) | 0/154 (0%) | 0/157 (0%) | ||||
| Vascular disorders | ||||||||
| Haematoma | 0/155 (0%) | 1/155 (0.6%) | 0/154 (0%) | 0/157 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | Tanezumab 2.5 mg | Tanezumab 5 mg | Tanezumab 10 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/155 (32.3%) | 64/155 (41.3%) | 58/154 (37.7%) | 59/157 (37.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 3/155 (1.9%) | 3/155 (1.9%) | 5/154 (3.2%) | 3/157 (1.9%) | ||||
| Nausea | 6/155 (3.9%) | 0/155 (0%) | 3/154 (1.9%) | 2/157 (1.3%) | ||||
| General disorders | ||||||||
| Oedema peripheral | 1/155 (0.6%) | 3/155 (1.9%) | 3/154 (1.9%) | 7/157 (4.5%) | ||||
| Peripheral swelling | 0/155 (0%) | 3/155 (1.9%) | 4/154 (2.6%) | 3/157 (1.9%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 2/155 (1.3%) | 5/155 (3.2%) | 3/154 (1.9%) | 3/157 (1.9%) | ||||
| Influenza | 5/155 (3.2%) | 4/155 (2.6%) | 2/154 (1.3%) | 1/157 (0.6%) | ||||
| Nasopharyngitis | 1/155 (0.6%) | 4/155 (2.6%) | 3/154 (1.9%) | 3/157 (1.9%) | ||||
| Sinusitis | 1/155 (0.6%) | 2/155 (1.3%) | 7/154 (4.5%) | 3/157 (1.9%) | ||||
| Upper respiratory tract infection | 2/155 (1.3%) | 7/155 (4.5%) | 10/154 (6.5%) | 10/157 (6.4%) | ||||
| Urinary tract infection | 3/155 (1.9%) | 8/155 (5.2%) | 7/154 (4.5%) | 3/157 (1.9%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Fall | 2/155 (1.3%) | 3/155 (1.9%) | 5/154 (3.2%) | 2/157 (1.3%) | ||||
| Muscle strain | 1/155 (0.6%) | 4/155 (2.6%) | 2/154 (1.3%) | 2/157 (1.3%) | ||||
| Investigations | ||||||||
| Blood creatine phosphokinase increased | 1/155 (0.6%) | 5/155 (3.2%) | 3/154 (1.9%) | 2/157 (1.3%) | ||||
| Liver function test abnormal | 1/155 (0.6%) | 0/155 (0%) | 5/154 (3.2%) | 0/157 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 5/155 (3.2%) | 9/155 (5.8%) | 4/154 (2.6%) | 9/157 (5.7%) | ||||
| Back pain | 4/155 (2.6%) | 6/155 (3.9%) | 3/154 (1.9%) | 5/157 (3.2%) | ||||
| Muscle spasms | 3/155 (1.9%) | 0/155 (0%) | 0/154 (0%) | 4/157 (2.5%) | ||||
| Osteoarthritis | 4/155 (2.6%) | 3/155 (1.9%) | 2/154 (1.3%) | 3/157 (1.9%) | ||||
| Pain in extremity | 4/155 (2.6%) | 6/155 (3.9%) | 4/154 (2.6%) | 10/157 (6.4%) | ||||
| Nervous system disorders | ||||||||
| Carpal tunnel syndrome | 1/155 (0.6%) | 2/155 (1.3%) | 3/154 (1.9%) | 6/157 (3.8%) | ||||
| Headache | 7/155 (4.5%) | 8/155 (5.2%) | 5/154 (3.2%) | 2/157 (1.3%) | ||||
| Hypoaesthesia | 3/155 (1.9%) | 6/155 (3.9%) | 2/154 (1.3%) | 3/157 (1.9%) | ||||
| Paraesthesia | 6/155 (3.9%) | 8/155 (5.2%) | 4/154 (2.6%) | 8/157 (5.1%) | ||||
| Psychiatric disorders | ||||||||
| Depression | 4/155 (2.6%) | 1/155 (0.6%) | 1/154 (0.6%) | 0/157 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 4/155 (2.6%) | 4/155 (2.6%) | 0/154 (0%) | 2/157 (1.3%) | ||||
| Vascular disorders | ||||||||
| Hypertension | 2/155 (1.3%) | 4/155 (2.6%) | 2/154 (1.3%) | 2/157 (1.3%) | ||||
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:
NCT00744471
Other Study ID Numbers:
- A4091014
- P3 OA HIP
First Posted:
Sep 1, 2008
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 1, 2021