Tanezumab in Osteoarthritis of the Knee
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00733902
Collaborator
(none)
697
82
4
16
8.5
0.5
Study Details
Study Description
Brief Summary
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
697 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 KNEE
Actual Study Start Date
:
Sep 15, 2008
Actual Primary Completion Date
:
Aug 24, 2009
Actual Study Completion Date
:
Jan 14, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tanezumab 10 mg
|
Biological: tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
|
| Experimental: Tanezumab 5 mg
|
Biological: tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
|
| Experimental: Tanezumab 2.5 mg
|
Biological: tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
|
| Placebo Comparator: Placebo
|
Biological: Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale 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 (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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 knee affects you, how are you doing today?". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Secondary Outcome Measures
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 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 OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 24]
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
- Change 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of 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]
OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, 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]
OMERACT-OARSI response: >= 50% improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).
- Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
- Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
- Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
- Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
- Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) [Baseline up to Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.
- Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) [Baseline up to Week 16]
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), 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 up to Week 16 are reported.
- Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24]
Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using difference between each post-baseline weekly mean and the Baseline mean score.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
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 knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 2, 4, 8, 12, 16, 24]
Participants answered, Question (Q)1: "How much pain have you had when walking on a flat surface?" and Q2: "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 = extreme pain.
- Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 12, 24]
SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition.
- Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) [Baseline, Week 12, 24]
SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population.
- 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 Medications [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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Osteoarthritis of the knee according to ACR criteria with a 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 knee injections arthroplasty or replace 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 or intent to become pregnant during the study
-
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 | Arizona Research Center, Inc. | Phoenix | Arizona | United States | 85023 |
| 2 | Clinical Research Center of Connecticut | Danbury | Connecticut | United States | 06810 |
| 3 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 4 | Javed Rheumatology Associates, Inc. | Newark | Delaware | United States | 19713 |
| 5 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
| 6 | Tampa Bay Medical Research, Inc. | Clearwater | Florida | United States | 33761 |
| 7 | Avail Clinical Rearch, LLC | DeLand | Florida | United States | 32720 |
| 8 | Avail Clinical Research | DeLand | Florida | United States | 32720 |
| 9 | Arthritis Associates of South Florida, Clinical Research Center | Delray Beach | Florida | United States | 33484 |
| 10 | Delray Research Associates | Delray Beach | Florida | United States | 33484 |
| 11 | Westside Center for Clinical Research | Jacksonville | Florida | United States | 32205 |
| 12 | Neurorehabilitation & Diagnostic Services | Miami | Florida | United States | 33126 |
| 13 | Pharmax Research Clinic, LLC | Miami | Florida | United States | 33126 |
| 14 | South Medical Research Group | Miami | Florida | United States | 33186 |
| 15 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
| 16 | The Arthritis Center | Palm Harbor | Florida | United States | 34684 |
| 17 | University Clinical Research Incorporated | Pembroke Pines | Florida | United States | 33024 |
| 18 | Advent Clinical Research Centers | Pinellas Park | Florida | United States | 33781 |
| 19 | AVIVOCLIN Clinical Services | Port Orange | Florida | United States | 32127 |
| 20 | Dale G. Bramlet, MD, P.L | Saint Petersburg | Florida | United States | 33713 |
| 21 | Palm Beach Research Center | West Palm Beach | Florida | United States | 33409 |
| 22 | Laureate Clinical Reseach Group | Atlanta | Georgia | United States | 30342 |
| 23 | Jefrey D. Lieberman, MD, PC | Decatur | Georgia | United States | 30033 |
| 24 | Early Family Practice Center | Fort Valley | Georgia | United States | 31030 |
| 25 | North Georgia Clinical Research | Marietta | Georgia | United States | 30060 |
| 26 | North Georgia Clinical Research | Woodstock | Georgia | United States | 30189 |
| 27 | North Georgia Internal Medicine | Woodstock | Georgia | United States | 30189 |
| 28 | Sonora Clinical Research | Boise | Idaho | United States | 83702 |
| 29 | The Arthritis Center | Springfield | Illinois | United States | 62704 |
| 30 | Memorial Health System, Inc./ Michiana Arthritis & Osteoporosis Center | South Bend | Indiana | United States | 46601-1071 |
| 31 | Memorial Health System, Inc. | South Bend | Indiana | United States | 46601 |
| 32 | Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | United States | 46383 |
| 33 | Arthritis Center of Lexington | Lexington | Kentucky | United States | 40504 |
| 34 | Bluegrass Community Research, Inc | Lexington | Kentucky | United States | 40515 |
| 35 | David H. Neustadt P.S.C. | Louisville | Kentucky | United States | 40202 |
| 36 | Gulf Coast Research, LLC | Baton Rouge | Louisiana | United States | 70808 |
| 37 | The Baton Rouge Clinic | Baton Rouge | Louisiana | United States | 70808 |
| 38 | Arthritis and Diabetes Clinic | Monroe | Louisiana | United States | 71203 |
| 39 | Maine Research Associates | Auburn | Maine | United States | 04210 |
| 40 | Office of Peter A. Holt, MD | Baltimore | Maryland | United States | 21239 |
| 41 | The Arthritis and Osteoporosis Center of Maryland | Frederick | Maryland | United States | 21702 |
| 42 | The Center for Rheumatology and Bone Research | Wheaton | Maryland | United States | 20902 |
| 43 | Mansfield Health Center | Mansfield | Massachusetts | United States | 02048 |
| 44 | Arthritis Associates Inc. | Peabody | Massachusetts | United States | 01960-1628 |
| 45 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01610 |
| 46 | Ann Arbor Clinical Research | Ann Arbor | Michigan | United States | 48103 |
| 47 | KMED Research | Saint Clair Shores | Michigan | United States | 48081 |
| 48 | MAPS Applied Research Center | Edina | Minnesota | United States | 55435 |
| 49 | Medical Advanced Pain Specialists | Edina | Minnesota | United States | 55435 |
| 50 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
| 51 | Clinical Research Consortium | Las Vegas | Nevada | United States | 89119 |
| 52 | Comprehensive Clinical Research | Berlin | New Jersey | United States | 08009 |
| 53 | Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | United States | 87102 |
| 54 | New Mexico Clinical Research & Osteoporosis Center, Incorporated | Albuquerque | New Mexico | United States | 87106 |
| 55 | Health Sciences Research Center at Asthma & Allergy Assoc., PC | Elmira | New York | United States | 14901 |
| 56 | Health Sciences Research Center at Asthma and Allergy Associates P.C. | Ithaca | New York | United States | 14850 |
| 57 | The Medical Research Network, LLC | New York | New York | United States | 10128 |
| 58 | Prem C. Chatpar, MD, LLC | Plainview | New York | United States | 11803 |
| 59 | AAIR Research Center | Rochester | New York | United States | 14618 |
| 60 | Arthristis and Osteoporosis Consultants of the Carolinas | Charlotte | North Carolina | United States | 28207-1198 |
| 61 | Pharmquest | Greensboro | North Carolina | United States | 27408 |
| 62 | C.A.R.E. Center | Raleigh | North Carolina | United States | 27609 |
| 63 | Piedmont Medical Research Associates | Winston-Salem | North Carolina | United States | 27103 |
| 64 | Hilltop Physicians Inc, Hightop Medical Research Center | Cincinnati | Ohio | United States | 45224 |
| 65 | Southwest Rheumatology and Research Group, LLC | Middleburg Heights | Ohio | United States | 44130 |
| 66 | Pharmacotherapy Research Associates,Inc | Zanesville | Ohio | United States | 43701 |
| 67 | Health Research Institute | Oklahoma City | Oklahoma | United States | 73109 |
| 68 | EPIC Imaging West | Beaverton | Oregon | United States | 97008 |
| 69 | EPIC Imaging East: | Portland | Oregon | United States | 97220 |
| 70 | Covance CRU, Inc. | Portland | Oregon | United States | 97239 |
| 71 | East Penn Rheumatology Associates, PC | Bethlehem | Pennsylvania | United States | 18015 |
| 72 | Brandywine Clinical Research | Downingtown | Pennsylvania | United States | 19335-2620 |
| 73 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635-0909 |
| 74 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
| 75 | Appalachian Medical Research | Johnson City | Tennessee | United States | 37604-1417 |
| 76 | Walter Chase, MD | Austin | Texas | United States | 78705 |
| 77 | Metroplex Clinical Research Center | Dallas | Texas | United States | 75231 |
| 78 | Radiant Research | San Antonio | Texas | United States | 78217 |
| 79 | Texas Arthritis Research Center, PA | San Antonio | Texas | United States | 78217 |
| 80 | Diagnostics Research Group | San Antonio | Texas | United States | 78229 |
| 81 | Charlottesville Medical Research | Charlottesville | Virginia | United States | 22911 |
| 82 | 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:
NCT00733902
Other Study ID Numbers:
- A4091011
- P3 OA KNEE
First Posted:
Aug 13, 2008
Last Update Posted:
Mar 22, 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 | Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091016 (NCT00809783). |
| 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 milligram (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 | 174 | 174 | 174 | 175 |
| Treated | 172 | 172 | 172 | 174 |
| COMPLETED | 10 | 12 | 13 | 11 |
| NOT COMPLETED | 164 | 162 | 161 | 164 |
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 milligram (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 | 172 | 172 | 172 | 174 | 690 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
62.2
(9.9)
|
60.8
(9.8)
|
62.1
(10.5)
|
61.4
(10.5)
|
61.6
(10.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
119
69.2%
|
94
54.7%
|
101
58.7%
|
106
60.9%
|
420
60.9%
|
| Male |
53
30.8%
|
78
45.3%
|
71
41.3%
|
68
39.1%
|
270
39.1%
|
Outcome Measures
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale 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 (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| Time Frame | Baseline (Day 1), Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat (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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
7.05
(1.45)
|
7.16
(1.44)
|
7.19
(1.41)
|
6.99
(1.43)
|
| Change at Week 16 |
-2.51
(2.63)
|
-3.27
(2.78)
|
-3.39
(2.65)
|
-3.67
(2.83)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | Analysis of Covariance (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 | 0.015 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) Mean Difference |
| Estimated Value | -0.73 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.14 |
|
| 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 | 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 | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.84 | |
| Confidence Interval |
(2-Sided) 95% -1.43 to -0.25 |
|
| 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 | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.20 | |
| Confidence Interval |
(2-Sided) 95% -1.78 to -0.61 |
|
| 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 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 154 | 155 | 154 |
| Baseline |
6.64
(1.59)
|
6.86
(1.58)
|
6.91
(1.49)
|
6.69
(1.62)
|
| Change at Week 16 |
-2.06
(2.45)
|
-2.93
(2.67)
|
-3.14
(2.59)
|
-3.34
(2.70)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | 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 | 0.009 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -1.32 to -0.19 |
|
| 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 | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.98 | |
| Confidence Interval |
(2-Sided) 95% -1.54 to -0.41 |
|
| 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 | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.24 | |
| Confidence Interval |
(2-Sided) 95% -1.80 to -0.68 |
|
| 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 16: 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
3.40
(0.58)
|
3.47
(0.63)
|
3.45
(0.63)
|
3.45
(0.59)
|
| Change at Week 16 |
-0.51
(0.83)
|
-0.87
(0.93)
|
-0.91
(0.95)
|
-1.05
(1.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Tanezumab 2.5 mg |
|---|---|---|
| Comments | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.52 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 | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.37 | |
| Confidence Interval |
(2-Sided) 95% -0.56 to -0.17 |
|
| 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 | 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.51 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to -0.31 |
|
| 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) Pain Subscale at Week 2, 4, 8, 12, 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| Time Frame | Baseline, Week 2, 4, 8, 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Change at Week 2 |
-2.75
(2.46)
|
-3.08
(2.55)
|
-2.52
(2.39)
|
-2.68
(2.56)
|
| Change at Week 4 |
-2.72
(2.39)
|
-3.70
(2.63)
|
-3.44
(2.40)
|
-3.72
(2.58)
|
| Change at Week 8 |
-2.53
(2.46)
|
-3.40
(2.54)
|
-3.32
(2.38)
|
-3.84
(2.56)
|
| Change at Week 12 |
-2.55
(2.59)
|
-3.70
(2.70)
|
-3.51
(2.70)
|
-3.80
(2.69)
|
| Change at Week 24 |
-2.39
(2.63)
|
-3.10
(2.84)
|
-2.99
(2.64)
|
-3.55
(2.91)
|
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 | 0.326 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 0.27 |
|
| 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 | 0.275 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.83 |
|
| 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 | 0.918 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.56 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.93 | |
| Confidence Interval |
(2-Sided) 95% -1.47 to -0.40 |
|
| 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 | 0.013 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.15 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.03 | |
| Confidence Interval |
(2-Sided) 95% -1.57 to -0.49 |
|
| 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 | 0.003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.82 | |
| Confidence Interval |
(2-Sided) 95% -1.36 to -0.28 |
|
| 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 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 | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.75 | |
| Confidence Interval |
(2-Sided) 95% -1.29 to -0.21 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.33 | |
| Confidence Interval |
(2-Sided) 95% -1.87 to -0.79 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.10 | |
| Confidence Interval |
(2-Sided) 95% -1.68 to -0.53 |
|
| 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.91 | |
| Confidence Interval |
(2-Sided) 95% -1.48 to -0.33 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.29 | |
| Confidence Interval |
(2-Sided) 95% -1.87 to -0.72 |
|
| 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 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 | 0.027 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to -0.08 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| 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 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 | 0.071 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.55 | |
| Confidence Interval |
(2-Sided) 95% -1.15 to 0.05 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.18 | |
| Confidence Interval |
(2-Sided) 95% -1.78 to -0.58 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.31 |
|
| Estimation Comments | ||
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
7.05
(1.45)
|
7.16
(1.44)
|
7.19
(1.41)
|
6.99
(1.43)
|
| Change at Week 2 |
-2.75
(2.46)
|
-3.08
(2.55)
|
-2.52
(2.39)
|
-2.68
(2.56)
|
| Change at Week 4 |
-2.89
(2.44)
|
-3.81
(2.57)
|
-3.45
(2.40)
|
-3.82
(2.54)
|
| Change at Week 8 |
-2.65
(2.44)
|
-3.44
(2.53)
|
-3.44
(2.32)
|
-4.01
(2.47)
|
| Change at Week 12 |
-2.95
(2.51)
|
-3.96
(2.53)
|
-3.77
(2.56)
|
-4.13
(2.49)
|
| Change at Week 16 |
-2.89
(2.57)
|
-3.46
(2.69)
|
-3.60
(2.54)
|
-4.17
(2.55)
|
| Change at Week 24 |
-2.93
(2.59)
|
-3.38
(2.72)
|
-3.40
(2.57)
|
-4.11
(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 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 | 0.326 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.27 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to 0.27 |
|
| 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 | 0.275 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.83 |
|
| 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 | 0.918 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | 0.03 | |
| Confidence Interval |
(2-Sided) 95% -0.51 to 0.56 |
|
| 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.85 | |
| Confidence Interval |
(2-Sided) 95% -1.39 to -0.32 |
|
| 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 | 0.052 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.53 | |
| Confidence Interval |
(2-Sided) 95% -1.06 to 0.00 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.97 | |
| Confidence Interval |
(2-Sided) 95% -1.50 to -0.44 |
|
| 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 | 0.006 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.74 | |
| Confidence Interval |
(2-Sided) 95% -1.26 to -0.21 |
|
| 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 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 | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.76 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to -0.24 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.38 | |
| Confidence Interval |
(2-Sided) 95% -1.91 to -0.86 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.96 | |
| Confidence Interval |
(2-Sided) 95% -1.50 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | 0.005 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.77 | |
| Confidence Interval |
(2-Sided) 95% -1.30 to -0.23 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.22 | |
| Confidence Interval |
(2-Sided) 95% -1.75 to -0.69 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | 0.061 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.53 | |
| Confidence Interval |
(2-Sided) 95% -1.07 to 0.02 |
|
| 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 | 0.021 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -1.20 to -0.10 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.30 | |
| Confidence Interval |
(2-Sided) 95% -1.85 to -0.76 |
|
| 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 | 0.166 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to 0.16 |
|
| 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 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 | 0.167 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.39 | |
| Confidence Interval |
(2-Sided) 95% -0.95 to 0.16 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.20 | |
| Confidence Interval |
(2-Sided) 95% -1.75 to -0.64 |
|
| 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 Function Subscale at Week 2, 4, 8, 12, 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 154 | 155 | 154 |
| Change at Week 2 |
-2.17
(2.40)
|
-2.85
(2.62)
|
-2.34
(2.27)
|
-2.61
(2.57)
|
| Change at Week 4 |
-2.13
(2.36)
|
-3.23
(2.66)
|
-3.09
(2.35)
|
-3.41
(2.56)
|
| Change at Week 8 |
-2.00
(2.31)
|
-2.97
(2.58)
|
-2.98
(2.36)
|
-3.47
(2.58)
|
| Change at Week 12 |
-2.13
(2.50)
|
-3.38
(2.64)
|
-3.25
(2.62)
|
-3.51
(2.66)
|
| Change at Week 24 |
-2.01
(2.44)
|
-2.77
(2.71)
|
-2.74
(2.61)
|
-3.23
(2.83)
|
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 | 0.044 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.54 | |
| Confidence Interval |
(2-Sided) 95% -1.07 to -0.02 |
|
| 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 | 0.875 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.48 |
|
| 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 | 0.129 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to 0.12 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.98 | |
| Confidence Interval |
(2-Sided) 95% -1.51 to -0.45 |
|
| 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.85 | |
| Confidence Interval |
(2-Sided) 95% -1.38 to -0.32 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.23 | |
| Confidence Interval |
(2-Sided) 95% -1.76 to -0.70 |
|
| 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 | 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.83 | |
| Confidence Interval |
(2-Sided) 95% -1.35 to -0.30 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.87 | |
| Confidence Interval |
(2-Sided) 95% -1.39 to -0.34 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.42 | |
| Confidence Interval |
(2-Sided) 95% -1.94 to -0.90 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.14 | |
| Confidence Interval |
(2-Sided) 95% -1.70 to -0.58 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.01 | |
| Confidence Interval |
(2-Sided) 95% -1.57 to -0.45 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.35 | |
| Confidence Interval |
(2-Sided) 95% -1.91 to -0.79 |
|
| 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 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 | 0.021 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.68 | |
| Confidence Interval |
(2-Sided) 95% -1.26 to -0.10 |
|
| 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: 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 | 0.029 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.64 | |
| Confidence Interval |
(2-Sided) 95% -1.22 to -0.07 |
|
| 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: 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.20 | |
| Confidence Interval |
(2-Sided) 95% -1.78 to -0.62 |
|
| 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 Function Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), 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. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 154 | 155 | 154 |
| Baseline |
6.64
(1.59)
|
6.86
(1.58)
|
6.91
(1.49)
|
6.69
(1.62)
|
| Change at Week 2 |
-2.17
(2.40)
|
-2.85
(2.62)
|
-2.34
(2.27)
|
-2.61
(2.57)
|
| Change at Week 4 |
-2.27
(2.46)
|
-3.36
(2.59)
|
-3.16
(2.32)
|
-3.51
(2.54)
|
| Change at Week 8 |
-2.06
(2.36)
|
-3.01
(2.55)
|
-3.12
(2.31)
|
-3.64
(2.51)
|
| Change at Week 12 |
-2.39
(2.52)
|
-3.55
(2.53)
|
-3.49
(2.52)
|
-3.80
(2.49)
|
| Change at Week 16 |
-2.33
(2.47)
|
-3.04
(2.60)
|
-3.31
(2.53)
|
-3.81
(2.47)
|
| Change at Week 24 |
-2.35
(2.55)
|
-2.96
(2.63)
|
-3.11
(2.62)
|
-3.78
(2.62)
|
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 | 0.044 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.54 | |
| Confidence Interval |
(2-Sided) 95% -1.07 to -0.02 |
|
| 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 | 0.875 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.04 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to 0.48 |
|
| 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 | 0.129 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.93 to 0.12 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.94 | |
| Confidence Interval |
(2-Sided) 95% -1.46 to -0.41 |
|
| 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 | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | L Mean Difference |
| Estimated Value | -0.76 | |
| Confidence Interval |
(2-Sided) 95% -1.28 to -0.24 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.19 | |
| Confidence Interval |
(2-Sided) 95% -1.71 to -0.67 |
|
| 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 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.82 | |
| Confidence Interval |
(2-Sided) 95% -1.33 to -0.30 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.95 | |
| Confidence Interval |
(2-Sided) 95% -1.46 to -0.43 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.53 | |
| Confidence Interval |
(2-Sided) 95% -2.04 to -1.02 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.26 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.03 | |
| Confidence Interval |
(2-Sided) 95% -1.56 to -0.51 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.99 | |
| Confidence Interval |
(2-Sided) 95% -1.52 to -0.46 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.37 | |
| Confidence Interval |
(2-Sided) 95% -1.90 to -0.85 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | 0.030 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.59 | |
| Confidence Interval |
(2-Sided) 95% -1.12 to -0.06 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | 0.002 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.86 | |
| Confidence Interval |
(2-Sided) 95% -1.39 to -0.32 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.43 | |
| Confidence Interval |
(2-Sided) 95% -1.96 to -0.90 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.27 |
|
| 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 | 0.085 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.48 | |
| Confidence Interval |
(2-Sided) 95% -1.03 to 0.07 |
|
| 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 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 | 0.026 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.63 | |
| Confidence Interval |
(2-Sided) 95% -1.18 to -0.08 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -1.39 | |
| Confidence Interval |
(2-Sided) 95% -1.94 to -0.84 |
|
| 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) Stiffness Subscales at Week 2, 4, 8, 12, 16, 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 OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
6.94
(1.80)
|
6.98
(1.90)
|
7.05
(1.69)
|
6.89
(2.04)
|
| Change at Week 2 |
-2.09
(2.53)
|
-2.91
(2.79)
|
-2.50
(2.60)
|
-2.70
(2.82)
|
| Change at Week 4 |
-2.12
(2.46)
|
-3.33
(2.79)
|
-3.28
(2.62)
|
-3.54
(2.75)
|
| Change at Week 8 |
-1.98
(2.48)
|
-2.91
(2.83)
|
-3.06
(2.55)
|
-3.70
(2.75)
|
| Change at Week 12 |
-2.10
(2.60)
|
-3.44
(2.94)
|
-3.38
(2.82)
|
-3.75
(2.92)
|
| Change at Week 16 |
-2.06
(2.47)
|
-2.95
(2.92)
|
-3.20
(2.72)
|
-3.50
(2.92)
|
| Change at Week 24 |
-2.02
(2.49)
|
-2.86
(2.87)
|
-2.68
(2.70)
|
-3.44
(3.03)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 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 OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
6.94
(1.80)
|
6.98
(1.90)
|
7.05
(1.69)
|
6.89
(2.04)
|
| Change at Week 2 |
-2.09
(2.53)
|
-2.91
(2.79)
|
-2.50
(2.60)
|
-2.70
(2.82)
|
| Change at Week 4 |
-2.31
(2.52)
|
-3.44
(2.71)
|
-3.32
(2.61)
|
-3.66
(2.79)
|
| Change at Week 8 |
-2.11
(2.47)
|
-2.96
(2.80)
|
-3.22
(2.47)
|
-3.83
(2.72)
|
| Change at Week 12 |
-2.42
(2.57)
|
-3.59
(2.82)
|
-3.62
(2.72)
|
-4.04
(2.79)
|
| Change at Week 16 |
-2.40
(2.45)
|
-3.07
(2.86)
|
-3.36
(2.67)
|
-3.99
(2.75)
|
| Change at Week 24 |
-2.45
(2.55)
|
-3.07
(2.77)
|
-3.07
(2.71)
|
-3.94
(2.88)
|
| Title | Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| Time Frame | Baseline, Week 2, 4, 8, 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Change at Week 2 |
-0.55
(0.87)
|
-0.91
(0.90)
|
-0.63
(0.88)
|
-0.82
(0.99)
|
| Change at Week 4 |
-0.55
(0.78)
|
-1.04
(0.92)
|
-1.04
(0.91)
|
-1.16
(0.99)
|
| Change at Week 8 |
-0.46
(0.73)
|
-0.84
(0.90)
|
-0.84
(0.91)
|
-1.16
(0.99)
|
| Change at Week 12 |
-0.53
(0.82)
|
-1.01
(0.98)
|
-0.94
(0.89)
|
-1.17
(1.03)
|
| Change at Week 24 |
-0.53
(0.83)
|
-0.77
(0.90)
|
-0.70
(0.94)
|
-0.93
(1.11)
|
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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | 0.486 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | 0.008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to -0.06 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to -0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.57 | |
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to -0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.54 to -0.17 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.67 | |
| Confidence Interval |
(2-Sided) 95% -0.85 to -0.49 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -0.63 to -0.25 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.57 to -0.19 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.61 | |
| Confidence Interval |
(2-Sided) 95% -0.80 to -0.42 |
|
| 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 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 | 0.035 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to -0.02 |
|
| 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 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 | 0.125 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.36 to 0.04 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to -0.18 |
|
| 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, 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
3.40
(0.58)
|
3.47
(0.63)
|
3.45
(0.63)
|
3.45
(0.59)
|
| Change at Week 2 |
-0.55
(0.87)
|
-0.91
(0.90)
|
-0.63
(0.88)
|
-0.82
(0.99)
|
| Change at Week 4 |
-0.57
(0.83)
|
-1.08
(0.91)
|
-1.05
(0.91)
|
-1.18
(1.00)
|
| Change at Week 8 |
-0.47
(0.79)
|
-0.86
(0.90)
|
-0.90
(0.92)
|
-1.21
(0.98)
|
| Change at Week 12 |
-0.60
(0.88)
|
-1.05
(0.97)
|
-0.99
(0.90)
|
-1.28
(1.03)
|
| Change at Week 16 |
-0.58
(0.91)
|
-0.90
(0.93)
|
-0.97
(0.96)
|
-1.19
(1.05)
|
| Change at Week 24 |
-0.60
(0.92)
|
-0.82
(0.90)
|
-0.82
(1.00)
|
-1.13
(1.12)
|
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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.32 | |
| Confidence Interval |
(2-Sided) 95% -0.49 to -0.14 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | 0.486 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.06 | |
| Confidence Interval |
(2-Sided) 95% -0.24 to 0.11 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | 0.008 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.24 | |
| Confidence Interval |
(2-Sided) 95% -0.42 to -0.06 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.46 | |
| Confidence Interval |
(2-Sided) 95% -0.64 to -0.28 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.44 | |
| Confidence Interval |
(2-Sided) 95% -0.62 to -0.26 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.57 | |
| Confidence Interval |
(2-Sided) 95% -0.75 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.35 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to -0.16 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.58 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.71 | |
| Confidence Interval |
(2-Sided) 95% -0.89 to -0.52 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.40 | |
| Confidence Interval |
(2-Sided) 95% -0.59 to -0.22 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | ||
| 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: 0.09 |
|
| 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.65 | |
| Confidence Interval |
(2-Sided) 95% -0.83 to -0.46 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.09 |
|
| 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 | 0.004 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.28 | |
| Confidence Interval |
(2-Sided) 95% -0.47 to -0.09 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.36 | |
| Confidence Interval |
(2-Sided) 95% -0.55 to -0.17 |
|
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.58 | |
| Confidence Interval |
(2-Sided) 95% -0.77 to -0.39 |
|
| 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 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 | 0.090 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.17 | |
| Confidence Interval |
(2-Sided) 95% -0.37 to 0.03 |
|
| 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 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 | 0.053 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.20 | |
| 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 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 | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean Difference |
| Estimated Value | -0.50 | |
| Confidence Interval |
(2-Sided) 95% -0.70 to -0.30 |
|
| 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 | OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2 |
62.3
36.2%
|
68.2
39.7%
|
60.9
35.4%
|
68.2
39.2%
|
| Week 4 |
57.1
33.2%
|
70.8
41.2%
|
75.0
43.6%
|
77.3
44.4%
|
| Week 8 |
52.6
30.6%
|
72.1
41.9%
|
73.7
42.8%
|
78.6
45.2%
|
| Week 12 |
53.2
30.9%
|
74.7
43.4%
|
74.4
43.3%
|
77.9
44.8%
|
| Week 16 |
53.9
31.3%
|
68.2
39.7%
|
69.9
40.6%
|
70.8
40.7%
|
| Week 24 |
51.3
29.8%
|
62.3
36.2%
|
64.1
37.3%
|
69.5
39.9%
|
| Title | Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) |
|---|---|
| Description | OMERACT-OARSI response: >= 50% improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2 |
62.3
36.2%
|
68.2
39.7%
|
60.9
35.4%
|
68.2
39.2%
|
| Week 4 |
61.7
35.9%
|
74.0
43%
|
76.3
44.4%
|
80.5
46.3%
|
| Week 8 |
57.1
33.2%
|
73.4
42.7%
|
77.6
45.1%
|
83.1
47.8%
|
| Week 12 |
64.9
37.7%
|
80.5
46.8%
|
81.4
47.3%
|
85.7
49.3%
|
| Week 16 |
65.6
38.1%
|
72.7
42.3%
|
75.6
44%
|
82.5
47.4%
|
| Week 24 |
65.6
38.1%
|
70.8
41.2%
|
75.0
43.6%
|
82.5
47.4%
|
| Title | Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2: >=30% reduction |
57.8
33.6%
|
60.4
35.1%
|
50.6
29.4%
|
55.2
31.7%
|
| Week 2: >=50% reduction |
40.9
23.8%
|
44.8
26%
|
32.1
18.7%
|
41.6
23.9%
|
| Week 4: >=30% reduction |
57.1
33.2%
|
66.2
38.5%
|
66.7
38.8%
|
72.1
41.4%
|
| Week 4: >=50% reduction |
40.3
23.4%
|
56.5
32.8%
|
50.6
29.4%
|
57.8
33.2%
|
| Week 8: >=30% reduction |
50.0
29.1%
|
65.6
38.1%
|
67.9
39.5%
|
74.0
42.5%
|
| Week 8: >=50% reduction |
38.3
22.3%
|
48.7
28.3%
|
50.0
29.1%
|
63.6
36.6%
|
| Week 12: >=30% reduction |
52.6
30.6%
|
67.5
39.2%
|
66.0
38.4%
|
73.4
42.2%
|
| Week 12: >=50% reduction |
39.0
22.7%
|
57.1
33.2%
|
56.4
32.8%
|
57.8
33.2%
|
| Week 16: >=30% reduction |
51.3
29.8%
|
64.3
37.4%
|
65.4
38%
|
68.2
39.2%
|
| Week 16: >=50% reduction |
39.0
22.7%
|
50.6
29.4%
|
50.0
29.1%
|
61.7
35.5%
|
| Week 24: >=30% reduction |
48.7
28.3%
|
59.7
34.7%
|
59.6
34.7%
|
66.9
38.4%
|
| Week 24: >=50% reduction |
40.3
23.4%
|
47.4
27.6%
|
44.9
26.1%
|
57.1
32.8%
|
| Title | Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2: >=30% reduction |
57.8
33.6%
|
60.4
35.1%
|
50.6
29.4%
|
55.2
31.7%
|
| Week 2: >=50% reduction |
40.9
23.8%
|
44.8
26%
|
32.1
18.7%
|
41.6
23.9%
|
| Week 4: >=30% reduction |
60.4
35.1%
|
69.5
40.4%
|
67.3
39.1%
|
74.7
42.9%
|
| Week 4: >=50% reduction |
42.2
24.5%
|
57.8
33.6%
|
50.6
29.4%
|
59.1
34%
|
| Week 8: >=30% reduction |
53.9
31.3%
|
66.9
38.9%
|
71.2
41.4%
|
77.9
44.8%
|
| Week 8: >=50% reduction |
39.0
22.7%
|
49.4
28.7%
|
51.3
29.8%
|
65.6
37.7%
|
| Week 12: >=30% reduction |
63.0
36.6%
|
73.4
42.7%
|
72.4
42.1%
|
79.9
45.9%
|
| Week 12: >=50% reduction |
42.9
24.9%
|
60.4
35.1%
|
58.3
33.9%
|
61.7
35.5%
|
| Week 16: >=30% reduction |
61.7
35.9%
|
68.8
40%
|
70.5
41%
|
78.6
45.2%
|
| Week 16: >=50% reduction |
42.2
24.5%
|
53.2
30.9%
|
51.3
29.8%
|
68.2
39.2%
|
| Week 24: >=30% reduction |
61.0
35.5%
|
66.2
38.5%
|
68.6
39.9%
|
78.6
45.2%
|
| Week 24: >=50% reduction |
44.8
26%
|
51.9
30.2%
|
49.4
28.7%
|
64.9
37.3%
|
| Title | Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2 |
11.7
6.8%
|
24.0
14%
|
14.7
8.5%
|
21.4
12.3%
|
| Week 4 |
10.4
6%
|
31.8
18.5%
|
24.4
14.2%
|
37.7
21.7%
|
| Week 8 |
9.1
5.3%
|
23.4
13.6%
|
19.9
11.6%
|
33.8
19.4%
|
| Week 12 |
15.6
9.1%
|
32.5
18.9%
|
24.4
14.2%
|
39.6
22.8%
|
| Week 16 |
13.6
7.9%
|
24.7
14.4%
|
23.7
13.8%
|
30.5
17.5%
|
| Week 24 |
16.2
9.4%
|
20.8
12.1%
|
18.6
10.8%
|
32.5
18.7%
|
| Title | Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: 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 on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2 |
11.7
6.8%
|
24.0
14%
|
14.7
8.5%
|
21.4
12.3%
|
| Week 4 |
11.7
6.8%
|
32.5
18.9%
|
24.4
14.2%
|
38.3
22%
|
| Week 8 |
10.4
6%
|
23.4
13.6%
|
21.2
12.3%
|
35.7
20.5%
|
| Week 12 |
17.5
10.2%
|
33.1
19.2%
|
25.0
14.5%
|
42.9
24.7%
|
| Week 16 |
15.6
9.1%
|
25.3
14.7%
|
25.0
14.5%
|
35.7
20.5%
|
| Week 24 |
18.8
10.9%
|
21.4
12.4%
|
21.8
12.7%
|
39.6
22.8%
|
| Title | Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported. |
| Time Frame | Baseline up to 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Greater than (>) 0% |
61.0
35.5%
|
79.2
46%
|
79.5
46.2%
|
76.0
43.7%
|
| >=10% |
59.7
34.7%
|
75.3
43.8%
|
78.2
45.5%
|
74.7
42.9%
|
| >=20% |
54.5
31.7%
|
70.8
41.2%
|
69.9
40.6%
|
70.1
40.3%
|
| >=30% |
51.3
29.8%
|
64.3
37.4%
|
65.4
38%
|
68.2
39.2%
|
| >=40% |
48.7
28.3%
|
58.4
34%
|
57.7
33.5%
|
67.5
38.8%
|
| >=50% |
67.5
39.2%
|
50.6
29.4%
|
50.0
29.1%
|
61.7
35.5%
|
| >=60% |
31.8
18.5%
|
39.0
22.7%
|
45.5
26.5%
|
55.8
32.1%
|
| >=70% |
23.4
13.6%
|
33.1
19.2%
|
39.1
22.7%
|
44.2
25.4%
|
| >=80% |
13.6
7.9%
|
27.3
15.9%
|
27.6
16%
|
31.8
18.3%
|
| >=90% |
5.2
3%
|
14.9
8.7%
|
12.8
7.4%
|
24.0
13.8%
|
| =100% |
0.1
0.1%
|
4.5
2.6%
|
5.8
3.4%
|
7.1
4.1%
|
| Title | Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), 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 up to Week 16 are reported. |
| Time Frame | Baseline up to 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| >0% |
84.4
49.1%
|
87.7
51%
|
92.9
54%
|
92.9
53.4%
|
| >=10% |
77.9
45.3%
|
83.1
48.3%
|
87.2
50.7%
|
90.9
52.2%
|
| >=20% |
66.2
38.5%
|
76.6
44.5%
|
75.6
44%
|
83.1
47.8%
|
| >=30% |
61.7
35.9%
|
68.8
40%
|
70.5
41%
|
78.6
45.2%
|
| >=40% |
55.2
32.1%
|
62.3
36.2%
|
60.3
35.1%
|
75.3
43.3%
|
| >=50% |
42.2
24.5%
|
53.2
30.9%
|
51.3
29.8%
|
68.2
39.2%
|
| >=60% |
33.8
19.7%
|
40.9
23.8%
|
46.2
26.9%
|
62.3
35.8%
|
| >=70% |
24.7
14.4%
|
33.8
19.7%
|
39.7
23.1%
|
47.4
27.2%
|
| >=80% |
14.3
8.3%
|
27.3
15.9%
|
28.2
16.4%
|
34.4
19.8%
|
| >=90% |
5.8
3.4%
|
14.9
8.7%
|
13.5
7.8%
|
25.3
14.5%
|
| =100% |
0.1
0.1%
|
4.5
2.6%
|
5.8
3.4%
|
8.4
4.8%
|
| Title | Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using difference between each post-baseline weekly mean and the Baseline mean score. |
| Time Frame | Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set. BOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 152 | 151 | 153 |
| Baseline |
6.38
(1.93)
|
6.70
(1.83)
|
6.74
(1.63)
|
6.55
(1.91)
|
| Change at Week 1 |
-1.21
(1.97)
|
-1.87
(2.04)
|
-1.83
(1.84)
|
-2.09
(2.03)
|
| Change at Week 2 |
-1.68
(2.21)
|
-2.12
(2.42)
|
-1.83
(2.02)
|
-2.15
(2.31)
|
| Change at Week 3 |
-1.73
(2.22)
|
-2.38
(2.52)
|
-1.90
(2.06)
|
-2.17
(2.47)
|
| Change at Week 4 |
-1.81
(2.32)
|
-2.73
(2.49)
|
-2.47
(2.14)
|
-2.99
(2.52)
|
| Change at Week 6 |
-1.83
(2.37)
|
-2.78
(2.66)
|
-2.50
(2.20)
|
-3.07
(2.59)
|
| Change at Week 8 |
-1.67
(2.28)
|
-2.45
(2.61)
|
-2.47
(2.18)
|
-3.10
(2.63)
|
| Change at Week 10 |
-1.84
(2.41)
|
-2.80
(2.76)
|
-2.65
(2.40)
|
-3.33
(2.82)
|
| Change at Week 12 |
-1.82
(2.37)
|
-2.91
(2.76)
|
-2.78
(2.52)
|
-3.27
(2.72)
|
| Change at Week 16 |
-1.73
(2.34)
|
-2.28
(2.69)
|
-2.58
(2.47)
|
-3.15
(2.76)
|
| Change at Week 20 |
-1.80
(2.30)
|
-2.80
(2.88)
|
-2.81
(2.54)
|
-3.27
(2.83)
|
| Change at Week 24 |
-1.63
(2.21)
|
-2.44
(2.78)
|
-2.29
(2.48)
|
-2.98
(2.93)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | 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 knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, 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 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline |
6.88
(1.43)
|
7.00
(1.46)
|
7.05
(1.38)
|
6.86
(1.52)
|
| Change at Week 2 |
-2.34
(2.31)
|
-2.95
(2.53)
|
-2.46
(2.29)
|
-2.67
(2.49)
|
| Change at Week 4 |
-2.32
(2.28)
|
-3.42
(2.58)
|
-3.29
(2.35)
|
-3.55
(2.50)
|
| Change at Week 8 |
-2.17
(2.28)
|
-3.09
(2.53)
|
-3.13
(2.31)
|
-3.68
(2.52)
|
| Change at Week 12 |
-2.26
(2.46)
|
-3.51
(2.65)
|
-3.38
(2.62)
|
-3.70
(2.64)
|
| Change at Week 16 |
-2.21
(2.41)
|
-3.05
(2.67)
|
-3.25
(2.56)
|
-3.51
(2.71)
|
| Change at Week 24 |
-2.14
(2.40)
|
-2.91
(2.70)
|
-2.81
(2.56)
|
-3.43
(2.82)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | Participants answered, Question (Q)1: "How much pain have you had when walking on a flat surface?" and Q2: "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 = extreme pain. |
| Time Frame | Baseline, Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies participants evaluated at specific time points for each arm 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 milligram (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 | 154 | 156 | 154 |
| Baseline: Q1 |
6.90
(1.67)
|
7.18
(1.72)
|
7.28
(1.59)
|
6.96
(1.71)
|
| Baseline: Q2 |
8.10
(1.45)
|
8.21
(1.55)
|
8.21
(1.45)
|
8.18
(1.44)
|
| Change at Week 2: Q1 |
-2.44
(2.58)
|
-3.23
(2.87)
|
-2.58
(2.56)
|
-2.95
(2.73)
|
| Change at Week 2: Q2 |
-2.49
(2.57)
|
-3.08
(2.84)
|
-2.59
(2.48)
|
-2.99
(2.66)
|
| Change at Week 4: Q1 |
-2.55
(2.50)
|
-3.78
(2.90)
|
-3.49
(2.49)
|
-3.89
(2.66)
|
| Change at Week 4: Q2 |
-2.54
(2.53)
|
-3.67
(2.96)
|
-3.43
(2.60)
|
-3.94
(2.80)
|
| Change at Week 8: Q1 |
-2.41
(2.64)
|
-3.40
(2.95)
|
-3.30
(2.45)
|
-3.86
(2.73)
|
| Change at Week 8: Q2 |
-2.34
(2.50)
|
-3.28
(2.91)
|
-3.26
(2.52)
|
-3.95
(2.87)
|
| Change at Week 12: Q1 |
-2.38
(2.65)
|
-3.73
(2.98)
|
-3.51
(2.82)
|
-3.75
(2.80)
|
| Change at Week 12: Q2 |
-2.42
(2.67)
|
-3.77
(3.08)
|
-3.48
(3.00)
|
-3.95
(3.04)
|
| Change at Week 16: Q1 |
-2.44
(2.73)
|
-3.26
(3.00)
|
-3.42
(2.84)
|
-3.64
(2.99)
|
| Change at Week 16: Q2 |
-2.28
(2.55)
|
-3.23
(3.00)
|
-3.37
(2.86)
|
-3.79
(3.02)
|
| Change at Week 24: Q1 |
-2.27
(2.66)
|
-3.10
(3.08)
|
-3.03
(2.80)
|
-3.56
(3.13)
|
| Change at Week 24: Q2 |
-2.13
(2.68)
|
-3.10
(3.09)
|
-2.97
(2.89)
|
-3.75
(3.07)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline: General health |
67.16
(18.72)
|
65.39
(17.74)
|
65.99
(17.82)
|
69.38
(17.47)
|
| Baseline: Physical Function |
32.64
(19.16)
|
30.52
(20.07)
|
30.46
(19.11)
|
33.42
(20.90)
|
| Baseline: Role Physical |
45.74
(25.76)
|
42.25
(24.41)
|
43.51
(24.39)
|
45.33
(27.98)
|
| Baseline: Bodily Pain |
34.48
(15.60)
|
33.84
(17.50)
|
33.50
(16.28)
|
34.20
(16.06)
|
| Baseline: Vitality |
51.42
(19.22)
|
54.26
(18.62)
|
55.25
(18.27)
|
53.45
(21.43)
|
| Baseline: Social Function |
69.48
(25.53)
|
68.91
(27.28)
|
70.03
(25.59)
|
72.65
(24.58)
|
| Baseline: Role Emotional |
73.43
(27.13)
|
67.48
(29.88)
|
71.85
(28.29)
|
71.37
(30.19)
|
| Baseline: Mental Health |
74.35
(16.18)
|
75.49
(18.23)
|
76.44
(16.86)
|
76.36
(17.42)
|
| Change at Week 12: General health |
3.28
(12.12)
|
3.62
(11.81)
|
5.81
(14.17)
|
5.11
(13.44)
|
| Change at Week 12: Physical Function |
8.26
(18.75)
|
19.99
(22.43)
|
18.12
(22.72)
|
19.34
(22.36)
|
| Change at Week 12: Role Physical |
8.97
(24.21)
|
19.85
(27.50)
|
19.51
(25.54)
|
18.06
(25.56)
|
| Change at Week 12: Bodily Pain |
11.83
(19.60)
|
22.46
(25.53)
|
21.19
(23.77)
|
24.36
(24.62)
|
| Change at Week 12: Vitality |
4.34
(14.62)
|
6.94
(16.16)
|
6.69
(18.58)
|
9.28
(17.04)
|
| Change at Week 12: Social Function |
6.25
(22.20)
|
10.96
(25.70)
|
11.46
(21.15)
|
7.47
(22.44)
|
| Change at Week 12: Role Emotional |
5.30
(21.28)
|
10.71
(26.47)
|
8.81
(23.95)
|
10.50
(28.26)
|
| Change at Week 12: Mental Health |
3.80
(13.59)
|
3.41
(14.08)
|
4.17
(15.91)
|
3.77
(14.02)
|
| Change at Week 24: General health |
3.38
(11.81)
|
4.27
(11.87)
|
3.31
(13.10)
|
2.94
(10.20)
|
| Change at Week 24: Physical Function |
8.75
(19.53)
|
15.25
(20.98)
|
13.54
(23.00)
|
17.97
(23.32)
|
| Change at Week 24: Role Physical |
7.75
(22.97)
|
14.12
(26.73)
|
12.82
(23.51)
|
17.21
(25.35)
|
| Change at Week 24: Bodily Pain |
11.68
(21.15)
|
15.34
(24.39)
|
14.23
(22.96)
|
19.02
(24.36)
|
| Change at Week 24: Vitality |
3.21
(14.40)
|
4.79
(15.75)
|
3.17
(14.80)
|
5.68
(14.56)
|
| Change at Week 24: Social Function |
4.95
(22.62)
|
6.98
(25.53)
|
7.69
(21.65)
|
7.87
(18.02)
|
| Change at Week 24: Role Emotional |
4.44
(20.08)
|
7.58
(23.56)
|
6.41
(22.18)
|
10.44
(25.25)
|
| Change at Week 24: Mental Health |
2.21
(12.30)
|
1.23
(14.39)
|
2.31
(13.24)
|
2.11
(13.88)
|
| Title | Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF) |
|---|---|
| Description | SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Baseline: Mental Component Aggregate |
0.23
(1.08)
|
0.21
(1.17)
|
0.34
(1.11)
|
0.30
(1.11)
|
| Baseline: Physical Component Aggregate |
-1.79
(0.77)
|
-1.86
(0.73)
|
-1.89
(0.72)
|
-1.76
(0.76)
|
| Change at Week 12: Mental Component Aggregate |
0.16
(0.83)
|
0.13
(0.98)
|
0.14
(0.94)
|
0.11
(0.90)
|
| Change at Week 12: Physical Component Aggregate |
0.37
(0.78)
|
0.82
(0.95)
|
0.80
(0.88)
|
0.83
(0.85)
|
| Change at Week 24: Mental Component Aggregate |
0.07
(0.73)
|
0.04
(0.94)
|
0.06
(0.80)
|
0.09
(0.83)
|
| Change at Week 24: Physical Component Aggregate |
0.38
(0.80)
|
0.63
(0.89)
|
0.55
(0.87)
|
0.72
(0.90)
|
| 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 milligram (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 | 172 | 172 | 172 | 174 |
| Median (Full Range) [days] |
NA
|
NA
|
NA
|
NA
|
| Title | Percentage of Participants Who Used Rescue Medications |
|---|---|
| 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. |
| 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 and from site 1006. 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 milligram (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 | 154 | 156 | 154 |
| Week 2 |
68.2
39.7%
|
63.0
36.6%
|
65.4
38%
|
66.0
37.9%
|
| Week 4 |
55.2
32.1%
|
40.3
23.4%
|
36.5
21.2%
|
40.5
23.3%
|
| Week 8 |
46.8
27.2%
|
42.9
24.9%
|
39.1
22.7%
|
39.9
22.9%
|
| Week 12 |
40.3
23.4%
|
30.5
17.7%
|
34.0
19.8%
|
32.7
18.8%
|
| Week 16 |
38.3
22.3%
|
40.9
23.8%
|
32.7
19%
|
31.4
18%
|
| Week 24 |
27.9
16.2%
|
35.7
20.8%
|
28.8
16.7%
|
26.8
15.4%
|
| 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. |
| Time Frame | Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 154 | 156 | 153 |
| Week 2 |
1.5
|
1.0
|
2.0
|
1.0
|
| Week 4 |
1.0
|
0.0
|
0.0
|
0.0
|
| Week 8 |
0.0
|
0.0
|
0.0
|
0.0
|
| Week 12 |
0.0
|
0.0
|
0.0
|
0.0
|
| Week 16 |
0.0
|
0.0
|
0.0
|
0.0
|
| Week 24 |
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. |
| Time Frame | Week 2, 4, 8, 12, 16, 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were 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 milligram (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 | 154 | 156 | 153 |
| Week 2 |
3493.51
(4969.51)
|
2818.18
(4063.15)
|
3419.87
(4759.20)
|
2993.46
(4226.71)
|
| Week 4 |
2691.56
(4484.61)
|
1925.32
(3943.13)
|
1891.03
(4038.24)
|
2065.36
(4510.11)
|
| Week 8 |
2383.12
(4292.72)
|
2133.12
(4199.69)
|
1753.21
(4109.59)
|
1934.64
(4568.45)
|
| Week 12 |
1941.56
(4184.45)
|
1788.96
(4455.58)
|
1567.31
(4359.67)
|
1977.12
(6122.20)
|
| Week 16 |
2058.44
(4440.22)
|
2207.79
(4696.58)
|
1820.51
(4615.52)
|
1663.40
(4367.50)
|
| Week 24 |
1704.55
(4183.54)
|
1879.87
(4351.79)
|
1836.54
(4768.57)
|
1588.24
(4443.03)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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 milligram (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 | 3/172 (1.7%) | 3/172 (1.7%) | 4/172 (2.3%) | 3/174 (1.7%) | ||||
| Cardiac disorders | ||||||||
| Angina pectoris | 1/172 (0.6%) | 0/172 (0%) | 0/172 (0%) | 0/174 (0%) | ||||
| Arteriosclerosis coronary artery | 0/172 (0%) | 0/172 (0%) | 0/172 (0%) | 1/174 (0.6%) | ||||
| Eye disorders | ||||||||
| Conjunctival oedema | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Concussion | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Fall | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Hip fracture | 1/172 (0.6%) | 0/172 (0%) | 0/172 (0%) | 0/174 (0%) | ||||
| Radius fracture | 0/172 (0%) | 0/172 (0%) | 1/172 (0.6%) | 0/174 (0%) | ||||
| Rib fracture | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Spinal compression fracture | 0/172 (0%) | 0/172 (0%) | 0/172 (0%) | 1/174 (0.6%) | ||||
| Traumatic brain injury | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/172 (0%) | 0/172 (0%) | 1/172 (0.6%) | 0/174 (0%) | ||||
| Osteoarthritis | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Osteonecrosis | 0/172 (0%) | 0/172 (0%) | 0/172 (0%) | 1/174 (0.6%) | ||||
| Nervous system disorders | ||||||||
| Cervicobrachial syndrome | 0/172 (0%) | 0/172 (0%) | 1/172 (0.6%) | 0/174 (0%) | ||||
| Subarachnoid haemorrhage | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 0/172 (0%) | 0/172 (0%) | 1/172 (0.6%) | 0/174 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/172 (0%) | 0/172 (0%) | 0/172 (0%) | 1/174 (0.6%) | ||||
| Pneumothorax | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Vascular disorders | ||||||||
| Femoral arterial stenosis | 0/172 (0%) | 1/172 (0.6%) | 0/172 (0%) | 0/174 (0%) | ||||
| Thrombosis | 1/172 (0.6%) | 0/172 (0%) | 0/172 (0%) | 0/174 (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 | 50/172 (29.1%) | 71/172 (41.3%) | 64/172 (37.2%) | 87/174 (50%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 8/172 (4.7%) | 5/172 (2.9%) | 2/172 (1.2%) | 4/174 (2.3%) | ||||
| Nausea | 3/172 (1.7%) | 1/172 (0.6%) | 4/172 (2.3%) | 6/174 (3.4%) | ||||
| General disorders | ||||||||
| Fatigue | 0/172 (0%) | 4/172 (2.3%) | 4/172 (2.3%) | 3/174 (1.7%) | ||||
| Infusion related reaction | 1/172 (0.6%) | 0/172 (0%) | 1/172 (0.6%) | 4/174 (2.3%) | ||||
| Oedema peripheral | 1/172 (0.6%) | 3/172 (1.7%) | 6/172 (3.5%) | 11/174 (6.3%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 1/172 (0.6%) | 2/172 (1.2%) | 5/172 (2.9%) | 4/174 (2.3%) | ||||
| Nasopharyngitis | 2/172 (1.2%) | 3/172 (1.7%) | 4/172 (2.3%) | 5/174 (2.9%) | ||||
| Sinusitis | 0/172 (0%) | 4/172 (2.3%) | 4/172 (2.3%) | 2/174 (1.1%) | ||||
| Upper respiratory tract infection | 7/172 (4.1%) | 10/172 (5.8%) | 11/172 (6.4%) | 7/174 (4%) | ||||
| Urinary tract infection | 3/172 (1.7%) | 1/172 (0.6%) | 4/172 (2.3%) | 8/174 (4.6%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 1/172 (0.6%) | 5/172 (2.9%) | 3/172 (1.7%) | 5/174 (2.9%) | ||||
| Fall | 3/172 (1.7%) | 6/172 (3.5%) | 5/172 (2.9%) | 7/174 (4%) | ||||
| Joint injury | 2/172 (1.2%) | 4/172 (2.3%) | 4/172 (2.3%) | 7/174 (4%) | ||||
| Investigations | ||||||||
| Blood creatine phosphokinase increased | 3/172 (1.7%) | 4/172 (2.3%) | 1/172 (0.6%) | 3/174 (1.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 7/172 (4.1%) | 8/172 (4.7%) | 4/172 (2.3%) | 13/174 (7.5%) | ||||
| Back pain | 3/172 (1.7%) | 4/172 (2.3%) | 5/172 (2.9%) | 2/174 (1.1%) | ||||
| Bursitis | 1/172 (0.6%) | 0/172 (0%) | 1/172 (0.6%) | 4/174 (2.3%) | ||||
| Joint effusion | 0/172 (0%) | 0/172 (0%) | 1/172 (0.6%) | 4/174 (2.3%) | ||||
| Joint swelling | 1/172 (0.6%) | 3/172 (1.7%) | 2/172 (1.2%) | 4/174 (2.3%) | ||||
| Muscle spasms | 2/172 (1.2%) | 3/172 (1.7%) | 2/172 (1.2%) | 4/174 (2.3%) | ||||
| Musculoskeletal pain | 2/172 (1.2%) | 5/172 (2.9%) | 2/172 (1.2%) | 2/174 (1.1%) | ||||
| Myalgia | 1/172 (0.6%) | 2/172 (1.2%) | 1/172 (0.6%) | 6/174 (3.4%) | ||||
| Pain in extremity | 5/172 (2.9%) | 3/172 (1.7%) | 1/172 (0.6%) | 9/174 (5.2%) | ||||
| Nervous system disorders | ||||||||
| Burning sensation | 0/172 (0%) | 0/172 (0%) | 0/172 (0%) | 4/174 (2.3%) | ||||
| Carpal tunnel syndrome | 1/172 (0.6%) | 4/172 (2.3%) | 2/172 (1.2%) | 5/174 (2.9%) | ||||
| Dizziness | 3/172 (1.7%) | 3/172 (1.7%) | 4/172 (2.3%) | 7/174 (4%) | ||||
| Headache | 13/172 (7.6%) | 6/172 (3.5%) | 9/172 (5.2%) | 9/174 (5.2%) | ||||
| Hypoaesthesia | 2/172 (1.2%) | 7/172 (4.1%) | 5/172 (2.9%) | 6/174 (3.4%) | ||||
| Paraesthesia | 3/172 (1.7%) | 5/172 (2.9%) | 6/172 (3.5%) | 9/174 (5.2%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 3/172 (1.7%) | 3/172 (1.7%) | 2/172 (1.2%) | 4/174 (2.3%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 1/172 (0.6%) | 1/172 (0.6%) | 1/172 (0.6%) | 4/174 (2.3%) | ||||
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:
NCT00733902
Other Study ID Numbers:
- A4091011
- P3 OA KNEE
First Posted:
Aug 13, 2008
Last Update Posted:
Mar 22, 2021
Last Verified:
Feb 1, 2021