Arthritis, Osteoarthritis
Conditions
Keywords
monoclonal antibody, nerve growth factor (NGF), anti-NGF, tanezumab, PF-04383119, RN624, osteoarthritis (OA)
Brief summary
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
Detailed description
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Interventions
DRUGNSAID
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
BIOLOGICALtanezumab
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2. * Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen. * Pain level and function levels as required by the protocol at Screening and Baseline. * Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol. * Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion criteria
* Pregnant women. * BMI greater than 39. * Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA. * Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening. * Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. * History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. * At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women). * Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening. * Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline, Week 16 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline, Week 16 | Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline, Week 16 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. |
| Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, and 24 | Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. |
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Weeks 2, 4, 8, 12, 16, and 24 | Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). |
| Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was \>=50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). |
| Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30%, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported. |
| Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30 percent, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported. |
| Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | Baseline, Week 16 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. |
| Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Baseline, Week 16 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. |
| Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Weeks 2, 4, 8, 12, 16, and 24 | Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported. |
| Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, 16, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 12 and 24 | The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 12, 24, 40, and 56 | The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. |
| Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | Baseline up to Week 56 | — |
| Time to Discontinuation Due to Lack of Efficacy | Baseline up to Week 56 | Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy. |
| Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | Baseline, Week 24 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Baseline, Week 24 and 56 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | Baseline, Week 24 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Baseline, Weeks 24 and 56 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | Baseline, Week 24 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Baseline, Weeks 24 and 56 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | Baseline, Week 24 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Baseline, Weeks 24, and 56 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. |
| Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56 | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. |
| Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56 | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. |
| Amount of Rescue Medication Used | Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56 | In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized. |
| Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline, Week 56 | — |
| Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline, Week 56 | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 64 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 | The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. |
| Plasma Trough (Pre-dose) Concentration of Tanezumab | Predose on Day 1, Weeks 16, 24, 40, and 56 | — |
| Number of Participants With Intravenous (IV) Doses of Study Medication | Baseline up to Week 48 | Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received. |
| Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Baseline, Weeks 2, 4, 8, 12, and 24 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
| Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56 | WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-Drug Antibody (ADA) Response | Baseline, Weeks 16, 40, 24, and 56 | Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=4.32 for tanezumab were considered ADA positive. |
| Number of Participants With Positive Urine or Serum Pregnancy Test | Baseline up to Week 56 | Female participants, who reported positive in urine or serum pregnancy test were reported. |
Countries
Canada, Colombia, India, Mexico, Netherlands, Philippines, Russia, South Africa, South Korea, Spain, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tanezumab 5 mg (Naproxen Exposure) Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | 285 |
| Tanezumab 10 mg (Naproxen Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48. | 288 |
| Tanezumab 5 mg + Naproxen 500 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | 280 |
| Tanezumab 10 mg + Naproxen 500 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | 288 |
| Naproxen 500 mg Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. | 283 |
| Tanezumab 5 mg (Celecoxib Exposure) Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | 256 |
| Tanezumab 10 mg (Celecoxib Exposure) Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48. | 254 |
| Tanezumab 5 mg + Celecoxib 100 mg Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | 256 |
| Tanezumab 10 mg + Celecoxib 100 mg Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48. | 254 |
| Celecoxib 100 mg Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48. | 256 |
| Total | 2,700 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 32 | 45 | 37 | 53 | 26 | 33 | 44 | 40 | 46 | 26 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 23 | 23 | 22 | 15 | 40 | 19 | 21 | 15 | 18 | 38 |
| Overall Study | Lost to Follow-up | 10 | 11 | 8 | 13 | 6 | 2 | 0 | 5 | 4 | 0 |
| Overall Study | Other | 10 | 2 | 7 | 10 | 5 | 3 | 2 | 3 | 4 | 3 |
| Overall Study | Protocol Violation | 7 | 14 | 14 | 12 | 14 | 6 | 4 | 6 | 9 | 3 |
| Overall Study | Randomized but not Treated | 3 | 1 | 6 | 0 | 5 | 0 | 1 | 1 | 2 | 1 |
| Overall Study | Study terminated by sponsor | 138 | 134 | 129 | 120 | 126 | 133 | 124 | 148 | 127 | 135 |
| Overall Study | Withdrawal by Subject | 32 | 27 | 31 | 33 | 34 | 29 | 27 | 19 | 18 | 20 |
| Overall Study | Withdrawn due to pregnancy | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Celecoxib 100 mg | Total | Tanezumab 5 mg (Naproxen Exposure) | Tanezumab 10 mg (Naproxen Exposure) | Tanezumab 5 mg + Naproxen 500 mg | Tanezumab 10 mg + Naproxen 500 mg | Naproxen 500 mg | Tanezumab 5 mg (Celecoxib Exposure) | Tanezumab 10 mg (Celecoxib Exposure) | Tanezumab 5 mg + Celecoxib 100 mg | Tanezumab 10 mg + Celecoxib 100 mg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 to 44 years | 3 Participants | 118 Participants | 20 Participants | 16 Participants | 18 Participants | 18 Participants | 14 Participants | 8 Participants | 3 Participants | 11 Participants | 7 Participants |
| Age, Customized 45 to 64 years | 144 Participants | 1539 Participants | 168 Participants | 181 Participants | 157 Participants | 171 Participants | 195 Participants | 134 Participants | 117 Participants | 139 Participants | 133 Participants |
| Age, Customized greater than or equal to (>=) 65 years | 109 Participants | 1043 Participants | 97 Participants | 91 Participants | 105 Participants | 99 Participants | 74 Participants | 114 Participants | 134 Participants | 106 Participants | 114 Participants |
| Sex: Female, Male Female | 189 Participants | 1904 Participants | 200 Participants | 208 Participants | 184 Participants | 192 Participants | 199 Participants | 192 Participants | 184 Participants | 179 Participants | 177 Participants |
| Sex: Female, Male Male | 67 Participants | 796 Participants | 85 Participants | 80 Participants | 96 Participants | 96 Participants | 84 Participants | 64 Participants | 70 Participants | 77 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 201 / 285 | 205 / 288 | 201 / 280 | 202 / 288 | 188 / 283 | 195 / 256 | 181 / 254 | 182 / 256 | 187 / 254 | 170 / 256 |
| serious Total, serious adverse events | 22 / 285 | 23 / 288 | 28 / 280 | 30 / 288 | 22 / 283 | 22 / 256 | 23 / 254 | 26 / 256 | 34 / 254 | 21 / 256 |
Outcome results
Primary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16
Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using baseline BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.39 units on a scale | Standard Deviation 0.63 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.54 units on a scale | Standard Deviation 0.9 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.41 units on a scale | Standard Deviation 0.62 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.63 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.39 units on a scale | Standard Deviation 0.63 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.61 units on a scale | Standard Deviation 0.89 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.39 units on a scale | Standard Deviation 0.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.72 units on a scale | Standard Deviation 1.01 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.53 units on a scale | Standard Deviation 0.75 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.38 units on a scale | Standard Deviation 0.63 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.69 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.44 units on a scale | Standard Deviation 0.65 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.64 units on a scale | Standard Deviation 0.86 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.48 units on a scale | Standard Deviation 0.63 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.45 units on a scale | Standard Deviation 0.67 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.76 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.41 units on a scale | Standard Deviation 0.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.75 units on a scale | Standard Deviation 0.9 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Baseline | 3.37 units on a scale | Standard Deviation 0.59 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 | Change at Week 16 | -0.51 units on a scale | Standard Deviation 0.86 |
Comparison: Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00895% CI: [-0.32, -0.05]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.25195% CI: [-0.22, 0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.25195% CI: [-0.22, 0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.96195% CI: [-0.14, 0.13]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.27295% CI: [-0.21, 0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.27195% CI: [-0.21, 0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.12895% CI: [-0.24, 0.03]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.13395% CI: [-0.24, 0.03]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.35, -0.08]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00495% CI: [-0.34, -0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.41495% CI: [-0.2, 0.08]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05795% CI: [-0.27, 0]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.27795% CI: [-0.06, 0.21]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.32895% CI: [-0.21, 0.07]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02695% CI: [-0.3, -0.02]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.86495% CI: [-0.15, 0.13]ANCOVA
Primary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using baseline observation carried forward (BOCF). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.39 units on a scale | Standard Deviation 1.61 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -1.80 units on a scale | Standard Deviation 2.2 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.50 units on a scale | Standard Deviation 1.57 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -1.97 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.52 units on a scale | Standard Deviation 1.65 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.09 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.33 units on a scale | Standard Deviation 1.65 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.26 units on a scale | Standard Deviation 2.31 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -1.34 units on a scale | Standard Deviation 2.08 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.32 units on a scale | Standard Deviation 1.64 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.11 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.49 units on a scale | Standard Deviation 1.55 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.12 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.44 units on a scale | Standard Deviation 1.53 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.41 units on a scale | Standard Deviation 1.66 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.28 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.27 units on a scale | Standard Deviation 1.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -2.41 units on a scale | Standard Deviation 2.54 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Baseline | 6.29 units on a scale | Standard Deviation 1.6 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 | Change at Week 16 | -1.48 units on a scale | Standard Deviation 2.07 |
Comparison: Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.28, -0.57]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.06, -0.33]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00195% CI: [-0.94, -0.23]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01595% CI: [-0.81, -0.09]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.45395% CI: [-0.49, 0.22]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.17795% CI: [-0.61, 0.11]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06295% CI: [-0.7, 0.02]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.21295% CI: [-0.59, 0.13]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.34, -0.54]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.15, -0.35]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00495% CI: [-0.98, -0.18]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00795% CI: [-0.95, -0.15]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.87995% CI: [-0.43, 0.37]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.3395% CI: [-0.6, 0.2]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08395% CI: [-0.75, 0.05]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.3695% CI: [-0.59, 0.21]ANCOVA
Primary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.46 units on a scale | Standard Deviation 1.72 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -1.80 units on a scale | Standard Deviation 2.15 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.47 units on a scale | Standard Deviation 1.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -1.84 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.57 units on a scale | Standard Deviation 1.67 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.12 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.39 units on a scale | Standard Deviation 1.62 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.18 units on a scale | Standard Deviation 2.31 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -1.28 units on a scale | Standard Deviation 1.96 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.32 units on a scale | Standard Deviation 1.62 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.13 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.67 units on a scale | Standard Deviation 1.6 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.09 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.58 units on a scale | Standard Deviation 1.58 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.57 units on a scale | Standard Deviation 1.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.27 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.39 units on a scale | Standard Deviation 1.62 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -2.41 units on a scale | Standard Deviation 2.43 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Baseline | 6.47 units on a scale | Standard Deviation 1.59 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 | Change at Week 16 | -1.42 units on a scale | Standard Deviation 2.03 |
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.23, -0.53]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.13, -0.43]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.87, -0.17]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00795% CI: [-0.83, -0.13]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.82495% CI: [-0.39, 0.31]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.195% CI: [-0.64, 0.06]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04495% CI: [-0.7, -0.01]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.56595% CI: [-0.45, 0.25]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.4, -0.62]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.2, -0.42]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-1.02, -0.24]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-1.02, -0.24]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.9895% CI: [-0.39, 0.4]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38395% CI: [-0.56, 0.22]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05795% CI: [-0.77, 0.01]ANCOVA
Comparison: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.31295% CI: [-0.59, 0.19]ANCOVA
Secondary
Amount of Rescue Medication Used
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.
Time frame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 17-24 | 2733.43 milligram (mg) | Standard Deviation 6432.63 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 49-56 | 2979.89 milligram (mg) | Standard Deviation 6413.29 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 3-4 | 3411.93 milligram (mg) | Standard Deviation 6929.86 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 41-48 | 2927.31 milligram (mg) | Standard Deviation 6460.58 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 5-8 | 2846.58 milligram (mg) | Standard Deviation 6532.4 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 33-40 | 2810.18 milligram (mg) | Standard Deviation 6445.83 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 9-12 | 2863.10 milligram (mg) | Standard Deviation 6547.23 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 1-2 | 3144.66 milligram (mg) | Standard Deviation 6878.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 25-32 | 2823.39 milligram (mg) | Standard Deviation 6441.86 |
| Tanezumab 5 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 13-16 | 2993.63 milligram (mg) | Standard Deviation 6587.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 49-56 | 2910.73 milligram (mg) | Standard Deviation 6626.26 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 3-4 | 3582.77 milligram (mg) | Standard Deviation 8814.22 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 41-48 | 2906.70 milligram (mg) | Standard Deviation 8324.75 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 5-8 | 2875.55 milligram (mg) | Standard Deviation 8372.63 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 33-40 | 2900.69 milligram (mg) | Standard Deviation 8319.96 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 17-24 | 2778.55 milligram (mg) | Standard Deviation 8311.86 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 25-32 | 2824.83 milligram (mg) | Standard Deviation 8313.77 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 13-16 | 2912.14 milligram (mg) | Standard Deviation 8426.72 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 1-2 | 3365.46 milligram (mg) | Standard Deviation 8829.47 |
| Tanezumab 10 mg (Naproxen Exposure) | Amount of Rescue Medication Used | Weeks 9-12 | 2955.84 milligram (mg) | Standard Deviation 8403.06 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 49-56 | 2938.47 milligram (mg) | Standard Deviation 6717.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 1-2 | 2739.96 milligram (mg) | Standard Deviation 7060.72 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 3-4 | 2660.11 milligram (mg) | Standard Deviation 6782.71 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 5-8 | 2131.45 milligram (mg) | Standard Deviation 6429.73 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 9-12 | 2291.41 milligram (mg) | Standard Deviation 6478.22 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 25-32 | 2548.20 milligram (mg) | Standard Deviation 6512.08 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 41-48 | 2673.48 milligram (mg) | Standard Deviation 6517.91 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 13-16 | 2562.94 milligram (mg) | Standard Deviation 6525.59 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 33-40 | 2608.91 milligram (mg) | Standard Deviation 6529.78 |
| Tanezumab 5 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2525.71 milligram (mg) | Standard Deviation 6490.27 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 33-40 | 2361.40 milligram (mg) | Standard Deviation 4541.68 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 13-16 | 2551.21 milligram (mg) | Standard Deviation 4793.92 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 5-8 | 2396.99 milligram (mg) | Standard Deviation 4684.26 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 25-32 | 2289.28 milligram (mg) | Standard Deviation 4563.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 1-2 | 3524.27 milligram (mg) | Standard Deviation 5665.78 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2261.93 milligram (mg) | Standard Deviation 4517.29 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 49-56 | 2545.36 milligram (mg) | Standard Deviation 4465.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 3-4 | 3066.65 milligram (mg) | Standard Deviation 5206.51 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 41-48 | 2373.66 milligram (mg) | Standard Deviation 4547.39 |
| Tanezumab 10 mg + Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 9-12 | 2415.93 milligram (mg) | Standard Deviation 4630.96 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 5-8 | 2991.01 milligram (mg) | Standard Deviation 4634.26 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 1-2 | 3543.99 milligram (mg) | Standard Deviation 5541.14 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 3-4 | 3415.52 milligram (mg) | Standard Deviation 5260.63 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 9-12 | 2919.20 milligram (mg) | Standard Deviation 4643.38 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 13-16 | 2920.39 milligram (mg) | Standard Deviation 4659.7 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2759.90 milligram (mg) | Standard Deviation 4426.38 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 25-32 | 2792.04 milligram (mg) | Standard Deviation 4555.75 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 33-40 | 2755.66 milligram (mg) | Standard Deviation 4503.88 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 41-48 | 2746.29 milligram (mg) | Standard Deviation 4498.19 |
| Naproxen 500 mg | Amount of Rescue Medication Used | Weeks 49-56 | 3106.46 milligram (mg) | Standard Deviation 4908.02 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 9-12 | 2380.78 milligram (mg) | Standard Deviation 3162.61 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 3-4 | 3255.16 milligram (mg) | Standard Deviation 4142.25 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 13-16 | 2450.55 milligram (mg) | Standard Deviation 3280.41 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 25-32 | 2383.27 milligram (mg) | Standard Deviation 3102.23 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 33-40 | 2449.87 milligram (mg) | Standard Deviation 3126.73 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 41-48 | 2521.27 milligram (mg) | Standard Deviation 3163.27 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 17-24 | 2261.84 milligram (mg) | Standard Deviation 2980 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 49-56 | 2840.21 milligram (mg) | Standard Deviation 3627.85 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 5-8 | 2571.99 milligram (mg) | Standard Deviation 3240.96 |
| Tanezumab 5 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 1-2 | 3132.30 milligram (mg) | Standard Deviation 4047.15 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 17-24 | 2725.86 milligram (mg) | Standard Deviation 6619.25 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 3-4 | 3769.17 milligram (mg) | Standard Deviation 7131.76 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 41-48 | 3033.87 milligram (mg) | Standard Deviation 6627.43 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 13-16 | 2938.95 milligram (mg) | Standard Deviation 6667.26 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 49-56 | 2770.28 milligram (mg) | Standard Deviation 3810.98 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 25-32 | 2927.44 milligram (mg) | Standard Deviation 6606.26 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 9-12 | 3008.85 milligram (mg) | Standard Deviation 6675.65 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 5-8 | 2969.34 milligram (mg) | Standard Deviation 6656.34 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 1-2 | 3834.79 milligram (mg) | Standard Deviation 7152.17 |
| Tanezumab 10 mg (Celecoxib Exposure) | Amount of Rescue Medication Used | Weeks 33-40 | 2976.37 milligram (mg) | Standard Deviation 6607.95 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 33-40 | 2428.51 milligram (mg) | Standard Deviation 3758.09 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 9-12 | 2166.23 milligram (mg) | Standard Deviation 3632.39 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 41-48 | 2408.58 milligram (mg) | Standard Deviation 3706.6 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 3-4 | 2672.18 milligram (mg) | Standard Deviation 4108.6 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 49-56 | 2511.61 milligram (mg) | Standard Deviation 3797.81 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 5-8 | 2140.44 milligram (mg) | Standard Deviation 3585.06 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2235.23 milligram (mg) | Standard Deviation 3702.39 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 25-32 | 2432.81 milligram (mg) | Standard Deviation 3783.3 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 1-2 | 2910.68 milligram (mg) | Standard Deviation 4285.74 |
| Tanezumab 5 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 13-16 | 2244.74 milligram (mg) | Standard Deviation 3642.93 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 5-8 | 2223.15 milligram (mg) | Standard Deviation 3624.98 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 9-12 | 2266.13 milligram (mg) | Standard Deviation 3753.34 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2370.30 milligram (mg) | Standard Deviation 3599.96 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 25-32 | 2723.26 milligram (mg) | Standard Deviation 3891.04 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 1-2 | 3250.69 milligram (mg) | Standard Deviation 4846.02 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 33-40 | 2682.35 milligram (mg) | Standard Deviation 3925.96 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 3-4 | 3011.67 milligram (mg) | Standard Deviation 4412.94 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 49-56 | 2842.74 milligram (mg) | Standard Deviation 3642.86 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 41-48 | 2618.83 milligram (mg) | Standard Deviation 3864.42 |
| Tanezumab 10 mg + Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 13-16 | 2486.23 milligram (mg) | Standard Deviation 3933.41 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 33-40 | 3032.17 milligram (mg) | Standard Deviation 6889.07 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 3-4 | 3281.23 milligram (mg) | Standard Deviation 6981.13 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 25-32 | 3126.26 milligram (mg) | Standard Deviation 6906.75 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 1-2 | 3455.85 milligram (mg) | Standard Deviation 8154.84 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 49-56 | 3035.33 milligram (mg) | Standard Deviation 4124.28 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 9-12 | 3067.56 milligram (mg) | Standard Deviation 6962.68 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 5-8 | 3182.45 milligram (mg) | Standard Deviation 6991.76 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 17-24 | 2816.00 milligram (mg) | Standard Deviation 6854.35 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 13-16 | 3269.78 milligram (mg) | Standard Deviation 7040.71 |
| Celecoxib 100 mg | Amount of Rescue Medication Used | Weeks 41-48 | 3101.63 milligram (mg) | Standard Deviation 6912.29 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
Time frame: Baseline, Weeks 12 and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 66.08 units on a scale | Standard Deviation 29.3 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 32.82 units on a scale | Standard Deviation 19.12 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 43.29 units on a scale | Standard Deviation 25.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 36.91 units on a scale | Standard Deviation 17.91 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 51.58 units on a scale | Standard Deviation 19.45 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 65.63 units on a scale | Standard Deviation 25.65 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 56.76 units on a scale | Standard Deviation 20.74 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 70.42 units on a scale | Standard Deviation 19.16 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 3.29 units on a scale | Standard Deviation 14.32 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 11.68 units on a scale | Standard Deviation 22.48 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 9.73 units on a scale | Standard Deviation 25.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 11.44 units on a scale | Standard Deviation 21.66 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 5.68 units on a scale | Standard Deviation 17.68 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 5.90 units on a scale | Standard Deviation 24.79 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 5.08 units on a scale | Standard Deviation 26.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 2.85 units on a scale | Standard Deviation 17.25 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 3.08 units on a scale | Standard Deviation 13.39 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 10.52 units on a scale | Standard Deviation 21.56 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 9.40 units on a scale | Standard Deviation 25.04 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 10.73 units on a scale | Standard Deviation 21.66 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 5.94 units on a scale | Standard Deviation 16.7 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 4.01 units on a scale | Standard Deviation 25.13 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 3.35 units on a scale | Standard Deviation 23.83 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 2.31 units on a scale | Standard Deviation 17.07 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 2.95 units on a scale | Standard Deviation 15.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 13.08 units on a scale | Standard Deviation 21.93 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 0.58 units on a scale | Standard Deviation 25.64 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 65.97 units on a scale | Standard Deviation 26.68 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 1.48 units on a scale | Standard Deviation 16.93 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 70.23 units on a scale | Standard Deviation 19.71 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 43.88 units on a scale | Standard Deviation 23.81 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 9.63 units on a scale | Standard Deviation 22.77 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 9.50 units on a scale | Standard Deviation 22.9 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 35.90 units on a scale | Standard Deviation 17.87 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 7.42 units on a scale | Standard Deviation 26.32 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 66.35 units on a scale | Standard Deviation 28.15 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 5.14 units on a scale | Standard Deviation 17.69 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 57.41 units on a scale | Standard Deviation 21.03 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 4.66 units on a scale | Standard Deviation 15.19 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 12.59 units on a scale | Standard Deviation 24.75 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 3.21 units on a scale | Standard Deviation 26.84 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 51.28 units on a scale | Standard Deviation 20.1 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 5.25 units on a scale | Standard Deviation 23.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 32.74 units on a scale | Standard Deviation 21.34 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 12.88 units on a scale | Standard Deviation 21.49 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 3.28 units on a scale | Standard Deviation 15.58 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 5.50 units on a scale | Standard Deviation 25.83 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 3.93 units on a scale | Standard Deviation 18.24 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 3.77 units on a scale | Standard Deviation 14.43 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 6.47 units on a scale | Standard Deviation 17.84 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 14.41 units on a scale | Standard Deviation 22.41 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 13.13 units on a scale | Standard Deviation 24.85 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 60.66 units on a scale | Standard Deviation 20.88 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 3.21 units on a scale | Standard Deviation 22.32 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 53.73 units on a scale | Standard Deviation 19.83 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 44.58 units on a scale | Standard Deviation 23.9 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 3.77 units on a scale | Standard Deviation 16.18 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 10.41 units on a scale | Standard Deviation 21.52 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 68.13 units on a scale | Standard Deviation 24.43 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 9.58 units on a scale | Standard Deviation 25.13 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 2.38 units on a scale | Standard Deviation 22.42 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 67.74 units on a scale | Standard Deviation 29.39 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 9.83 units on a scale | Standard Deviation 22.63 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 72.20 units on a scale | Standard Deviation 19.67 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 34.79 units on a scale | Standard Deviation 20.63 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 0.95 units on a scale | Standard Deviation 15.78 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 0.96 units on a scale | Standard Deviation 16.77 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 3.66 units on a scale | Standard Deviation 15.27 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 37.80 units on a scale | Standard Deviation 17.49 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 4.91 units on a scale | Standard Deviation 25.97 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 5.36 units on a scale | Standard Deviation 23.74 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 14.23 units on a scale | Standard Deviation 25.26 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 4.47 units on a scale | Standard Deviation 24.64 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 70.40 units on a scale | Standard Deviation 18.77 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 16.53 units on a scale | Standard Deviation 22.55 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 13.04 units on a scale | Standard Deviation 21.24 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 37.67 units on a scale | Standard Deviation 17.89 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 3.04 units on a scale | Standard Deviation 15.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 7.76 units on a scale | Standard Deviation 23.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 4.52 units on a scale | Standard Deviation 16.59 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 52.57 units on a scale | Standard Deviation 19.76 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 6.14 units on a scale | Standard Deviation 22.56 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 14.38 units on a scale | Standard Deviation 24.59 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 57.92 units on a scale | Standard Deviation 22.08 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 5.14 units on a scale | Standard Deviation 15.96 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 12.30 units on a scale | Standard Deviation 24.18 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 15.39 units on a scale | Standard Deviation 26.13 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 67.92 units on a scale | Standard Deviation 29.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 33.88 units on a scale | Standard Deviation 18.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 44.69 units on a scale | Standard Deviation 23.6 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 11.54 units on a scale | Standard Deviation 25.1 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 2.26 units on a scale | Standard Deviation 15.92 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 4.54 units on a scale | Standard Deviation 14.38 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 6.12 units on a scale | Standard Deviation 18.16 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 2.16 units on a scale | Standard Deviation 22.64 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 64.47 units on a scale | Standard Deviation 25.28 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 46.09 units on a scale | Standard Deviation 24.57 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 35.72 units on a scale | Standard Deviation 16.34 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 50.78 units on a scale | Standard Deviation 18.94 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 62.23 units on a scale | Standard Deviation 26.33 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 68.45 units on a scale | Standard Deviation 28.65 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 70.34 units on a scale | Standard Deviation 19.78 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 2.92 units on a scale | Standard Deviation 22.96 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 5.76 units on a scale | Standard Deviation 21.38 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 3.88 units on a scale | Standard Deviation 15.25 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 6.70 units on a scale | Standard Deviation 23.58 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 7.83 units on a scale | Standard Deviation 19.22 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 3.97 units on a scale | Standard Deviation 15.62 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 7.41 units on a scale | Standard Deviation 24.36 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 0.92 units on a scale | Standard Deviation 23.38 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 1.57 units on a scale | Standard Deviation 15.44 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 2.90 units on a scale | Standard Deviation 14.43 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 5.75 units on a scale | Standard Deviation 19.12 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 1.52 units on a scale | Standard Deviation 14.67 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 7.28 units on a scale | Standard Deviation 22.16 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 8.87 units on a scale | Standard Deviation 19.6 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 1.90 units on a scale | Standard Deviation 14.77 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 6.16 units on a scale | Standard Deviation 23.26 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 57.61 units on a scale | Standard Deviation 21.97 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 35.46 units on a scale | Standard Deviation 19.94 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 5.46 units on a scale | Standard Deviation 14.25 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 7.41 units on a scale | Standard Deviation 17.89 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 12.70 units on a scale | Standard Deviation 22.24 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 5.81 units on a scale | Standard Deviation 26.42 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 10.19 units on a scale | Standard Deviation 25.95 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 8.23 units on a scale | Standard Deviation 28.14 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 42.59 units on a scale | Standard Deviation 23.69 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 3.00 units on a scale | Standard Deviation 15.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 70.95 units on a scale | Standard Deviation 17.94 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 33.43 units on a scale | Standard Deviation 20.62 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 4.07 units on a scale | Standard Deviation 15.59 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 63.02 units on a scale | Standard Deviation 28.66 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 10.40 units on a scale | Standard Deviation 22.45 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 10.24 units on a scale | Standard Deviation 23.6 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 1.33 units on a scale | Standard Deviation 14.5 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 63.19 units on a scale | Standard Deviation 24.26 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 10.69 units on a scale | Standard Deviation 21.07 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 50.52 units on a scale | Standard Deviation 18.21 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 5.71 units on a scale | Standard Deviation 17.61 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 7.63 units on a scale | Standard Deviation 23.13 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 34.14 units on a scale | Standard Deviation 16.39 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 56.20 units on a scale | Standard Deviation 20.62 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 13.36 units on a scale | Standard Deviation 25.67 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 16.74 units on a scale | Standard Deviation 21.52 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 9.05 units on a scale | Standard Deviation 22.01 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 4.95 units on a scale | Standard Deviation 25.97 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 10.22 units on a scale | Standard Deviation 23.32 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 6.25 units on a scale | Standard Deviation 25.58 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 0.42 units on a scale | Standard Deviation 15.32 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 51.52 units on a scale | Standard Deviation 21.07 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 71.08 units on a scale | Standard Deviation 19.16 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 4.00 units on a scale | Standard Deviation 18.26 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 3.37 units on a scale | Standard Deviation 15.13 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 5.36 units on a scale | Standard Deviation 25.97 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 3.64 units on a scale | Standard Deviation 28.43 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 42.86 units on a scale | Standard Deviation 23.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 10.04 units on a scale | Standard Deviation 26.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 4.25 units on a scale | Standard Deviation 16.34 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 12.50 units on a scale | Standard Deviation 22.6 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 64.07 units on a scale | Standard Deviation 28.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 35.57 units on a scale | Standard Deviation 18 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 34.79 units on a scale | Standard Deviation 19.21 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 9.33 units on a scale | Standard Deviation 19.85 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 56.93 units on a scale | Standard Deviation 20.48 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 63.68 units on a scale | Standard Deviation 25.44 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 4.35 units on a scale | Standard Deviation 17.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 10.46 units on a scale | Standard Deviation 25.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 0.36 units on a scale | Standard Deviation 16.85 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 5.18 units on a scale | Standard Deviation 13.96 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 17.15 units on a scale | Standard Deviation 23.61 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 13.84 units on a scale | Standard Deviation 24.37 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 64.51 units on a scale | Standard Deviation 24.58 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 62.68 units on a scale | Standard Deviation 29.21 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 14.02 units on a scale | Standard Deviation 23.34 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 8.14 units on a scale | Standard Deviation 24.3 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 3.78 units on a scale | Standard Deviation 17.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 15.51 units on a scale | Standard Deviation 26.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 51.45 units on a scale | Standard Deviation 19.16 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 56.34 units on a scale | Standard Deviation 20.39 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 42.65 units on a scale | Standard Deviation 24.9 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 34.11 units on a scale | Standard Deviation 16.66 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 7.06 units on a scale | Standard Deviation 25.35 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 8.63 units on a scale | Standard Deviation 26.82 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 2.84 units on a scale | Standard Deviation 17.03 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 6.47 units on a scale | Standard Deviation 24.2 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 0.94 units on a scale | Standard Deviation 15.01 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 11.83 units on a scale | Standard Deviation 23.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 68.25 units on a scale | Standard Deviation 19.23 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 6.32 units on a scale | Standard Deviation 17.13 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 33.41 units on a scale | Standard Deviation 22.07 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 10.93 units on a scale | Standard Deviation 25.86 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 3.46 units on a scale | Standard Deviation 14.82 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 5.78 units on a scale | Standard Deviation 22.67 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 6.82 units on a scale | Standard Deviation 26.37 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 3.39 units on a scale | Standard Deviation 24.12 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 71.07 units on a scale | Standard Deviation 19.83 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 3.17 units on a scale | Standard Deviation 17.39 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 58.27 units on a scale | Standard Deviation 20.65 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 65.05 units on a scale | Standard Deviation 28.53 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 4.28 units on a scale | Standard Deviation 15.77 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 13.71 units on a scale | Standard Deviation 25.39 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 12.00 units on a scale | Standard Deviation 23.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 66.90 units on a scale | Standard Deviation 24.16 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 35.11 units on a scale | Standard Deviation 20.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 10.50 units on a scale | Standard Deviation 23.87 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 16.83 units on a scale | Standard Deviation 22.01 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 53.63 units on a scale | Standard Deviation 18.42 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 13.47 units on a scale | Standard Deviation 21.19 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 45.60 units on a scale | Standard Deviation 22.57 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 4.15 units on a scale | Standard Deviation 16.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 0.87 units on a scale | Standard Deviation 16.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 36.47 units on a scale | Standard Deviation 16.93 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 12.99 units on a scale | Standard Deviation 24.3 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 6.47 units on a scale | Standard Deviation 17.88 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 8.94 units on a scale | Standard Deviation 23.9 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 5.66 units on a scale | Standard Deviation 16.53 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Bodily pain | 8.72 units on a scale | Standard Deviation 19.45 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Mental health | 0.00 units on a scale | Standard Deviation 16.15 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Physical function at baseline | 32.81 units on a scale | Standard Deviation 19.57 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Vitality at baseline | 51.52 units on a scale | Standard Deviation 17.9 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Social function | 4.07 units on a scale | Standard Deviation 21.74 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role physical | 7.70 units on a scale | Standard Deviation 20.85 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role physical | 7.58 units on a scale | Standard Deviation 23.58 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Physical function | 8.00 units on a scale | Standard Deviation 18.72 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Role emotional | 4.13 units on a scale | Standard Deviation 24.69 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Vitality | 2.43 units on a scale | Standard Deviation 15.51 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Role emotional | 2.23 units on a scale | Standard Deviation 23.18 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Social function at baseline | 64.31 units on a scale | Standard Deviation 24.07 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: General health | 3.90 units on a scale | Standard Deviation 15.8 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: General health | 4.68 units on a scale | Standard Deviation 16 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role physical at baseline | 43.55 units on a scale | Standard Deviation 22.7 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | General health at baseline | 55.69 units on a scale | Standard Deviation 22.22 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Role emotional at baseline | 63.39 units on a scale | Standard Deviation 28.73 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Mental health | 0.67 units on a scale | Standard Deviation 15.99 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24: Vitality | 2.87 units on a scale | Standard Deviation 16.25 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Mental health at baseline | 69.08 units on a scale | Standard Deviation 18.69 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Bodily pain at baseline | 36.96 units on a scale | Standard Deviation 17.6 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Social function | 3.33 units on a scale | Standard Deviation 23.87 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Physical function | 7.48 units on a scale | Standard Deviation 18.88 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12: Bodily pain | 8.01 units on a scale | Standard Deviation 19.68 |
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
Time frame: Baseline, Weeks 12, 24, 40, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 3.95 units on a scale | Standard Deviation 14.92 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 32.82 units on a scale | Standard Deviation 19.12 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 43.29 units on a scale | Standard Deviation 25.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 11.44 units on a scale | Standard Deviation 21.66 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 5.68 units on a scale | Standard Deviation 17.68 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 5.90 units on a scale | Standard Deviation 24.79 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 5.08 units on a scale | Standard Deviation 26.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 2.85 units on a scale | Standard Deviation 17.25 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 3.29 units on a scale | Standard Deviation 14.32 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 11.70 units on a scale | Standard Deviation 22.93 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 11.14 units on a scale | Standard Deviation 26.65 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 12.95 units on a scale | Standard Deviation 22.92 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 7.17 units on a scale | Standard Deviation 18.11 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 5.19 units on a scale | Standard Deviation 27.51 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 5.22 units on a scale | Standard Deviation 26.39 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 2.90 units on a scale | Standard Deviation 18.22 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.40 units on a scale | Standard Deviation 15.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 10.00 units on a scale | Standard Deviation 22.96 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 9.64 units on a scale | Standard Deviation 26.06 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 11.27 units on a scale | Standard Deviation 23.45 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 5.92 units on a scale | Standard Deviation 17.95 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 4.05 units on a scale | Standard Deviation 27.36 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 4.08 units on a scale | Standard Deviation 27.04 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 2.16 units on a scale | Standard Deviation 19.27 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.12 units on a scale | Standard Deviation 15.53 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 9.95 units on a scale | Standard Deviation 22.78 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 9.13 units on a scale | Standard Deviation 26 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 11.58 units on a scale | Standard Deviation 23 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 5.70 units on a scale | Standard Deviation 18.1 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 4.53 units on a scale | Standard Deviation 26.95 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 4.23 units on a scale | Standard Deviation 28.3 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 2.28 units on a scale | Standard Deviation 19.24 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 5.14 units on a scale | Standard Deviation 17.69 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 3.10 units on a scale | Standard Deviation 19.16 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 1.41 units on a scale | Standard Deviation 17.56 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 1.42 units on a scale | Standard Deviation 17.72 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 3.56 units on a scale | Standard Deviation 28.56 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 1.91 units on a scale | Standard Deviation 26.29 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 2.95 units on a scale | Standard Deviation 28.04 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 3.28 units on a scale | Standard Deviation 15.58 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 5.25 units on a scale | Standard Deviation 23.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 11.63 units on a scale | Standard Deviation 24.07 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 3.21 units on a scale | Standard Deviation 28.09 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 4.34 units on a scale | Standard Deviation 18.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 3.30 units on a scale | Standard Deviation 19.26 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 10.21 units on a scale | Standard Deviation 24.18 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 10.73 units on a scale | Standard Deviation 23.77 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 13.08 units on a scale | Standard Deviation 21.93 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 8.79 units on a scale | Standard Deviation 27.05 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 3.18 units on a scale | Standard Deviation 16.54 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 8.01 units on a scale | Standard Deviation 27.09 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 32.74 units on a scale | Standard Deviation 21.34 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 9.53 units on a scale | Standard Deviation 28.68 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 10.23 units on a scale | Standard Deviation 24.17 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 9.19 units on a scale | Standard Deviation 24.31 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 2.45 units on a scale | Standard Deviation 16.52 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 4.66 units on a scale | Standard Deviation 15.19 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 1.51 units on a scale | Standard Deviation 17.97 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 2.31 units on a scale | Standard Deviation 16.84 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 11.35 units on a scale | Standard Deviation 24.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 5.50 units on a scale | Standard Deviation 25.83 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 1.53 units on a scale | Standard Deviation 26.76 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 1.56 units on a scale | Standard Deviation 27.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 43.88 units on a scale | Standard Deviation 23.81 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 1.99 units on a scale | Standard Deviation 24.59 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 4.42 units on a scale | Standard Deviation 18.09 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 10.71 units on a scale | Standard Deviation 26.82 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 11.75 units on a scale | Standard Deviation 23.05 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 6.47 units on a scale | Standard Deviation 17.84 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 3.66 units on a scale | Standard Deviation 15.27 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 14.41 units on a scale | Standard Deviation 22.41 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 4.17 units on a scale | Standard Deviation 18.73 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 10.38 units on a scale | Standard Deviation 23.28 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 5.36 units on a scale | Standard Deviation 23.74 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 44.58 units on a scale | Standard Deviation 23.9 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 10.49 units on a scale | Standard Deviation 26.86 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 10.19 units on a scale | Standard Deviation 24.94 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 2.59 units on a scale | Standard Deviation 16.83 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 4.91 units on a scale | Standard Deviation 25.97 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | -0.11 units on a scale | Standard Deviation 18.49 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 0.25 units on a scale | Standard Deviation 18.14 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 2.80 units on a scale | Standard Deviation 24.3 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 2.19 units on a scale | Standard Deviation 23.43 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 0.96 units on a scale | Standard Deviation 16.77 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 34.79 units on a scale | Standard Deviation 20.63 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 4.42 units on a scale | Standard Deviation 18.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 10.79 units on a scale | Standard Deviation 23.42 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 10.98 units on a scale | Standard Deviation 26.99 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 3.93 units on a scale | Standard Deviation 16.09 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 10.49 units on a scale | Standard Deviation 24.89 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 2.83 units on a scale | Standard Deviation 16.57 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 0.45 units on a scale | Standard Deviation 17.97 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 3.63 units on a scale | Standard Deviation 24.03 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 10.85 units on a scale | Standard Deviation 24.77 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 1.65 units on a scale | Standard Deviation 23.4 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 2.81 units on a scale | Standard Deviation 24 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 3.82 units on a scale | Standard Deviation 18.9 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 16.53 units on a scale | Standard Deviation 22.55 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 6.12 units on a scale | Standard Deviation 18.16 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 3.99 units on a scale | Standard Deviation 24.98 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 7.76 units on a scale | Standard Deviation 23.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 4.47 units on a scale | Standard Deviation 24.64 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 3.04 units on a scale | Standard Deviation 15.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 4.66 units on a scale | Standard Deviation 15.46 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 13.73 units on a scale | Standard Deviation 24.6 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 13.03 units on a scale | Standard Deviation 26.16 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 14.73 units on a scale | Standard Deviation 21.67 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 5.48 units on a scale | Standard Deviation 18.13 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 7.11 units on a scale | Standard Deviation 23.55 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 3.10 units on a scale | Standard Deviation 24.18 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 0.47 units on a scale | Standard Deviation 25.5 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 2.65 units on a scale | Standard Deviation 16.96 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.87 units on a scale | Standard Deviation 16.28 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 11.96 units on a scale | Standard Deviation 25.3 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 10.00 units on a scale | Standard Deviation 26.77 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 12.42 units on a scale | Standard Deviation 21.98 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 4.45 units on a scale | Standard Deviation 18.58 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 4.56 units on a scale | Standard Deviation 25.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 0.76 units on a scale | Standard Deviation 25.47 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 1.76 units on a scale | Standard Deviation 16.34 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.69 units on a scale | Standard Deviation 16.54 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 1.53 units on a scale | Standard Deviation 16.55 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 11.15 units on a scale | Standard Deviation 25 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 9.01 units on a scale | Standard Deviation 26.81 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 11.92 units on a scale | Standard Deviation 22.25 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 5.14 units on a scale | Standard Deviation 15.96 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 33.88 units on a scale | Standard Deviation 18.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 44.69 units on a scale | Standard Deviation 23.6 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 1.67 units on a scale | Standard Deviation 25.9 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 7.47 units on a scale | Standard Deviation 19.17 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 5.95 units on a scale | Standard Deviation 19.75 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 7.19 units on a scale | Standard Deviation 23.29 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.47 units on a scale | Standard Deviation 16.07 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 0.41 units on a scale | Standard Deviation 16.13 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 7.23 units on a scale | Standard Deviation 24.46 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 1.57 units on a scale | Standard Deviation 15.44 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 2.57 units on a scale | Standard Deviation 16.19 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 2.59 units on a scale | Standard Deviation 25.68 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.33 units on a scale | Standard Deviation 16.26 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 46.09 units on a scale | Standard Deviation 24.57 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 3.77 units on a scale | Standard Deviation 16.48 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 0.49 units on a scale | Standard Deviation 16.26 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 6.23 units on a scale | Standard Deviation 19.34 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 2.32 units on a scale | Standard Deviation 17.09 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 7.11 units on a scale | Standard Deviation 19.38 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 7.83 units on a scale | Standard Deviation 19.22 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 35.46 units on a scale | Standard Deviation 19.94 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 1.38 units on a scale | Standard Deviation 16.71 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 2.68 units on a scale | Standard Deviation 16.53 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 3.88 units on a scale | Standard Deviation 15.25 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 9.19 units on a scale | Standard Deviation 21.1 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 6.43 units on a scale | Standard Deviation 21.08 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 7.01 units on a scale | Standard Deviation 23.65 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 7.23 units on a scale | Standard Deviation 23.97 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 7.41 units on a scale | Standard Deviation 24.36 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 3.97 units on a scale | Standard Deviation 15.62 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 7.32 units on a scale | Standard Deviation 25.07 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 7.97 units on a scale | Standard Deviation 24.14 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 0.92 units on a scale | Standard Deviation 23.38 |
| Naproxen 500 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 1.61 units on a scale | Standard Deviation 26 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 4.82 units on a scale | Standard Deviation 18.47 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 11.74 units on a scale | Standard Deviation 24.66 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 11.45 units on a scale | Standard Deviation 21.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 11.23 units on a scale | Standard Deviation 23.56 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 3.00 units on a scale | Standard Deviation 15.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 5.46 units on a scale | Standard Deviation 14.25 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 5.29 units on a scale | Standard Deviation 18.95 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 11.52 units on a scale | Standard Deviation 21.79 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 16.74 units on a scale | Standard Deviation 21.52 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 7.43 units on a scale | Standard Deviation 25.14 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 7.73 units on a scale | Standard Deviation 25.15 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.75 units on a scale | Standard Deviation 14.82 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 10.12 units on a scale | Standard Deviation 22.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 12.70 units on a scale | Standard Deviation 22.24 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 1.37 units on a scale | Standard Deviation 15.33 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 10.19 units on a scale | Standard Deviation 25.95 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 7.41 units on a scale | Standard Deviation 17.89 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.74 units on a scale | Standard Deviation 15.63 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 11.20 units on a scale | Standard Deviation 25.54 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 1.22 units on a scale | Standard Deviation 16.42 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 8.51 units on a scale | Standard Deviation 24.64 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 5.95 units on a scale | Standard Deviation 18.32 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 6.10 units on a scale | Standard Deviation 28.74 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 4.42 units on a scale | Standard Deviation 15.98 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 9.91 units on a scale | Standard Deviation 22.72 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 13.36 units on a scale | Standard Deviation 25.67 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 12.24 units on a scale | Standard Deviation 21.85 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 1.10 units on a scale | Standard Deviation 16.47 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 8.23 units on a scale | Standard Deviation 28.14 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 11.32 units on a scale | Standard Deviation 25.78 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 6.73 units on a scale | Standard Deviation 28.21 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 6.69 units on a scale | Standard Deviation 27.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 4.35 units on a scale | Standard Deviation 17.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 5.36 units on a scale | Standard Deviation 25.97 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 10.46 units on a scale | Standard Deviation 26.83 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 8.25 units on a scale | Standard Deviation 21.73 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 10.32 units on a scale | Standard Deviation 23.48 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 0.18 units on a scale | Standard Deviation 18.05 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 0.30 units on a scale | Standard Deviation 16.71 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 4.59 units on a scale | Standard Deviation 17.08 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 9.05 units on a scale | Standard Deviation 22.01 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.31 units on a scale | Standard Deviation 16.35 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 12.00 units on a scale | Standard Deviation 24.21 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 8.74 units on a scale | Standard Deviation 21.92 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 7.09 units on a scale | Standard Deviation 27.25 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 3.25 units on a scale | Standard Deviation 30.06 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 6.10 units on a scale | Standard Deviation 27.69 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 10.53 units on a scale | Standard Deviation 26.49 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 4.87 units on a scale | Standard Deviation 19.75 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 10.87 units on a scale | Standard Deviation 23.44 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 0.36 units on a scale | Standard Deviation 16.85 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 4.40 units on a scale | Standard Deviation 19.47 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 11.84 units on a scale | Standard Deviation 27.3 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 6.20 units on a scale | Standard Deviation 27.82 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 3.37 units on a scale | Standard Deviation 15.13 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 12.50 units on a scale | Standard Deviation 22.6 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 2.99 units on a scale | Standard Deviation 30.27 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 3.64 units on a scale | Standard Deviation 28.43 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 0.26 units on a scale | Standard Deviation 18.11 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 5.09 units on a scale | Standard Deviation 28.41 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.41 units on a scale | Standard Deviation 16.14 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 4.47 units on a scale | Standard Deviation 19.74 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 10.00 units on a scale | Standard Deviation 21.47 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 10.04 units on a scale | Standard Deviation 26.31 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 3.78 units on a scale | Standard Deviation 17.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 6.11 units on a scale | Standard Deviation 28.11 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 6.83 units on a scale | Standard Deviation 25.37 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 5.98 units on a scale | Standard Deviation 27.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 12.92 units on a scale | Standard Deviation 24.02 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 12.38 units on a scale | Standard Deviation 28.71 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 8.63 units on a scale | Standard Deviation 26.82 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 12.07 units on a scale | Standard Deviation 24.08 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 7.35 units on a scale | Standard Deviation 26.34 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 12.32 units on a scale | Standard Deviation 24.17 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 13.84 units on a scale | Standard Deviation 24.37 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.20 units on a scale | Standard Deviation 15.93 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 11.96 units on a scale | Standard Deviation 28.82 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 1.22 units on a scale | Standard Deviation 15.48 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 15.51 units on a scale | Standard Deviation 26.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 3.72 units on a scale | Standard Deviation 15.54 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 15.22 units on a scale | Standard Deviation 24.37 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 1.39 units on a scale | Standard Deviation 15.75 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 3.41 units on a scale | Standard Deviation 17.7 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 6.32 units on a scale | Standard Deviation 17.13 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 3.09 units on a scale | Standard Deviation 17.82 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 17.15 units on a scale | Standard Deviation 23.61 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 5.18 units on a scale | Standard Deviation 13.96 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 6.23 units on a scale | Standard Deviation 26.15 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 13.53 units on a scale | Standard Deviation 24.12 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 6.03 units on a scale | Standard Deviation 25.56 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 3.24 units on a scale | Standard Deviation 17.68 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 8.14 units on a scale | Standard Deviation 24.3 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 1.47 units on a scale | Standard Deviation 15.63 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 11.84 units on a scale | Standard Deviation 27.49 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 13.96 units on a scale | Standard Deviation 23.88 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.10 units on a scale | Standard Deviation 15.85 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.75 units on a scale | Standard Deviation 16.71 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 12.91 units on a scale | Standard Deviation 24.35 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 16.83 units on a scale | Standard Deviation 22.01 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 6.57 units on a scale | Standard Deviation 24.56 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 4.58 units on a scale | Standard Deviation 26.67 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 4.62 units on a scale | Standard Deviation 16.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 1.06 units on a scale | Standard Deviation 18.13 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 3.45 units on a scale | Standard Deviation 16.95 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 11.78 units on a scale | Standard Deviation 25.11 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 12.99 units on a scale | Standard Deviation 24.3 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 12.13 units on a scale | Standard Deviation 24.46 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 3.17 units on a scale | Standard Deviation 17.39 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 13.28 units on a scale | Standard Deviation 21.69 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 5.07 units on a scale | Standard Deviation 26.11 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 4.17 units on a scale | Standard Deviation 16.83 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 6.23 units on a scale | Standard Deviation 25.29 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 6.82 units on a scale | Standard Deviation 26.37 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 5.47 units on a scale | Standard Deviation 26.06 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 1.11 units on a scale | Standard Deviation 17.41 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 4.50 units on a scale | Standard Deviation 18.07 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 8.94 units on a scale | Standard Deviation 23.9 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 11.48 units on a scale | Standard Deviation 24.8 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 12.06 units on a scale | Standard Deviation 24.38 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 13.71 units on a scale | Standard Deviation 25.39 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 13.36 units on a scale | Standard Deviation 21.53 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 6.47 units on a scale | Standard Deviation 17.88 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 4.15 units on a scale | Standard Deviation 16.66 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 5.66 units on a scale | Standard Deviation 16.53 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 12.45 units on a scale | Standard Deviation 24.96 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 14.83 units on a scale | Standard Deviation 21.76 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 1.25 units on a scale | Standard Deviation 17.22 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 6.67 units on a scale | Standard Deviation 24.59 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Physical function | 8.41 units on a scale | Standard Deviation 20.14 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Mental health | 0.82 units on a scale | Standard Deviation 18.76 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role emotional | 3.41 units on a scale | Standard Deviation 27.05 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role physical | 7.58 units on a scale | Standard Deviation 23.58 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Role emotional | 4.13 units on a scale | Standard Deviation 24.69 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Mental health | 0.96 units on a scale | Standard Deviation 18.44 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Social function at Week 40 | 2.65 units on a scale | Standard Deviation 25.28 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role emotional | 3.51 units on a scale | Standard Deviation 27.41 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Bodily pain | 8.01 units on a scale | Standard Deviation 19.68 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: General health | 4.68 units on a scale | Standard Deviation 16 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Vitality | 2.67 units on a scale | Standard Deviation 18.06 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Bodily pain | 8.17 units on a scale | Standard Deviation 19.11 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: General health | 4.45 units on a scale | Standard Deviation 16.75 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role physical | 8.27 units on a scale | Standard Deviation 22.89 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Social function | 2.84 units on a scale | Standard Deviation 25.01 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Physical function | 7.48 units on a scale | Standard Deviation 18.88 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Role physical | 7.58 units on a scale | Standard Deviation 23.43 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Vitality | 2.08 units on a scale | Standard Deviation 17.89 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Mental health | 0.67 units on a scale | Standard Deviation 15.99 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: Physical function | 7.24 units on a scale | Standard Deviation 20.71 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40: General health | 4.09 units on a scale | Standard Deviation 16.42 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Mental health | 0.20 units on a scale | Standard Deviation 18.25 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Role emotional | 2.76 units on a scale | Standard Deviation 25.33 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Bodily pain | 9.09 units on a scale | Standard Deviation 20.09 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Social function | 3.97 units on a scale | Standard Deviation 24.47 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24: Vitality | 2.40 units on a scale | Standard Deviation 17.96 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Bodily pain | 8.69 units on a scale | Standard Deviation 19.35 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Vitality | 2.43 units on a scale | Standard Deviation 15.51 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Role physical | 7.28 units on a scale | Standard Deviation 23.78 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: Physical function | 6.91 units on a scale | Standard Deviation 20.39 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56: General health | 3.99 units on a scale | Standard Deviation 16.87 |
| Celecoxib 100 mg | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12: Social function | 3.33 units on a scale | Standard Deviation 23.87 |
Secondary
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56
Time frame: Baseline, Week 56
Population: Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline | 2.769 millimeter (mm) | Standard Deviation 2.077 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Change at Week 56 | -0.189 millimeter (mm) | Standard Deviation 0.97 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline | 2.850 millimeter (mm) | Standard Deviation 2.077 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Change at Week 56 | -0.213 millimeter (mm) | Standard Deviation 1.069 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline | 3.005 millimeter (mm) | Standard Deviation 2.068 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Change at Week 56 | -0.162 millimeter (mm) | Standard Deviation 1.069 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Change at Week 56 | -0.172 millimeter (mm) | Standard Deviation 1.096 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline | 2.982 millimeter (mm) | Standard Deviation 2.106 |
| Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Baseline | 3.022 millimeter (mm) | Standard Deviation 2.09 |
| Naproxen 500 mg | Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56 | Change at Week 56 | -0.041 millimeter (mm) | Standard Deviation 0.85 |
Secondary
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56
Time frame: Baseline, Week 56
Population: Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline | 2.447 millimeter | Standard Deviation 1.364 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Change at Week 56 | -0.075 millimeter | Standard Deviation 0.587 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline | 2.372 millimeter | Standard Deviation 1.433 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Change at Week 56 | -0.137 millimeter | Standard Deviation 0.619 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline | 2.346 millimeter | Standard Deviation 1.424 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Change at Week 56 | -0.240 millimeter | Standard Deviation 0.599 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Change at Week 56 | -0.136 millimeter | Standard Deviation 0.437 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline | 2.195 millimeter | Standard Deviation 1.561 |
| Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Baseline | 2.724 millimeter | Standard Deviation 1.525 |
| Naproxen 500 mg | Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56 | Change at Week 56 | -0.028 millimeter | Standard Deviation 0.477 |
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.49 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.50 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.77 units on a scale | Standard Deviation 2.77 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.64 units on a scale | Standard Deviation 5.96 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.43 units on a scale | Standard Deviation 3.27 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.48 units on a scale | Standard Deviation 3.83 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.20 units on a scale | Standard Deviation 1.61 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.52 units on a scale | Standard Deviation 2.33 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.73 units on a scale | Standard Deviation 3.07 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.37 units on a scale | Standard Deviation 1.88 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.56 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.46 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.55 units on a scale | Standard Deviation 2.82 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.46 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.58 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.57 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.53 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.25 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.48 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.56 units on a scale | Standard Deviation 5.82 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.57 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.43 units on a scale | Standard Deviation 2.88 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.38 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.44 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.45 units on a scale | Standard Deviation 2.95 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.30 units on a scale | Standard Deviation 1.78 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 1.93 units on a scale | Standard Deviation 4.34 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.38 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.20 units on a scale | Standard Deviation 1.66 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.25 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.32 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.52 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.35 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.33 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.16 units on a scale | Standard Deviation 1.98 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.53 units on a scale | Standard Deviation 3.41 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.58 units on a scale | Standard Deviation 3.02 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.58 units on a scale | Standard Deviation 3.3 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.65 units on a scale | Standard Deviation 3.2 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.60 units on a scale | Standard Deviation 3.02 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.49 units on a scale | Standard Deviation 3.57 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.65 units on a scale | Standard Deviation 3.93 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.54 units on a scale | Standard Deviation 6.43 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.38 units on a scale | Standard Deviation 2.51 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.31 units on a scale | Standard Deviation 2.49 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.12 units on a scale | Standard Deviation 2.29 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.31 units on a scale | Standard Deviation 6.34 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.18 units on a scale | Standard Deviation 2.62 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.08 units on a scale | Standard Deviation 2.2 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.32 units on a scale | Standard Deviation 2.32 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.43 units on a scale | Standard Deviation 2.63 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.11 units on a scale | Standard Deviation 1.94 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.26 units on a scale | Standard Deviation 2.54 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.46 units on a scale | Standard Deviation 2.72 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.40 units on a scale | Standard Deviation 2.73 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.43 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.04 units on a scale | Standard Deviation 4.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.11 units on a scale | Standard Deviation 1.87 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.21 units on a scale | Standard Deviation 1.5 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.32 units on a scale | Standard Deviation 2 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.53 units on a scale | Standard Deviation 1.93 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.35 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.44 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.41 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.44 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.41 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.52 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.56 units on a scale | Standard Deviation 2.28 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.38 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.30 units on a scale | Standard Deviation 1.9 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.50 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.35 units on a scale | Standard Deviation 2.2 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.29 units on a scale | Standard Deviation 2.03 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.09 units on a scale | Standard Deviation 4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.44 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.50 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.56 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.50 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.87 units on a scale | Standard Deviation 2.9 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.40 units on a scale | Standard Deviation 1.99 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.14 units on a scale | Standard Deviation 1.6 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.93 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.24 units on a scale | Standard Deviation 4.84 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.79 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.53 units on a scale | Standard Deviation 2.06 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.90 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.89 units on a scale | Standard Deviation 2.9 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.69 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.33 units on a scale | Standard Deviation 1.55 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.22 units on a scale | Standard Deviation 4.47 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.26 units on a scale | Standard Deviation 4.78 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.26 units on a scale | Standard Deviation 4.44 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.33 units on a scale | Standard Deviation 3.79 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.40 units on a scale | Standard Deviation 2.24 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.33 units on a scale | Standard Deviation 4.34 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.43 units on a scale | Standard Deviation 4.45 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.34 units on a scale | Standard Deviation 4.4 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.08 units on a scale | Standard Deviation 4.86 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.30 units on a scale | Standard Deviation 4.34 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.36 units on a scale | Standard Deviation 3.51 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.13 units on a scale | Standard Deviation 2.79 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 2.18 units on a scale | Standard Deviation 5.2 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.36 units on a scale | Standard Deviation 3.37 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.34 units on a scale | Standard Deviation 3.46 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.22 units on a scale | Standard Deviation 2.96 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.34 units on a scale | Standard Deviation 3.2 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.41 units on a scale | Standard Deviation 3.4 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.34 units on a scale | Standard Deviation 1.71 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.39 units on a scale | Standard Deviation 3.52 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.28 units on a scale | Standard Deviation 3.05 |
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.47 units on a scale | Standard Deviation 2.17 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.61 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.81 units on a scale | Standard Deviation 2.91 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.64 units on a scale | Standard Deviation 5.96 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.55 units on a scale | Standard Deviation 3.44 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.30 units on a scale | Standard Deviation 5.01 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.20 units on a scale | Standard Deviation 1.61 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.53 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.78 units on a scale | Standard Deviation 3.26 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.40 units on a scale | Standard Deviation 1.93 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.56 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.42 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.47 units on a scale | Standard Deviation 2.91 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.42 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.81 units on a scale | Standard Deviation 2.56 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.53 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.70 units on a scale | Standard Deviation 2.91 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.25 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.41 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.56 units on a scale | Standard Deviation 5.82 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.50 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.38 units on a scale | Standard Deviation 2.95 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.34 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.57 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.83 units on a scale | Standard Deviation 4.14 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.30 units on a scale | Standard Deviation 1.78 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 1.93 units on a scale | Standard Deviation 4.34 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.67 units on a scale | Standard Deviation 2.77 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.18 units on a scale | Standard Deviation 1.68 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.22 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.63 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.78 units on a scale | Standard Deviation 2.97 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.38 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.29 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.16 units on a scale | Standard Deviation 1.98 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.47 units on a scale | Standard Deviation 3.51 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.58 units on a scale | Standard Deviation 2.82 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.10 units on a scale | Standard Deviation 3.27 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.80 units on a scale | Standard Deviation 3.46 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.57 units on a scale | Standard Deviation 2.88 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.38 units on a scale | Standard Deviation 3.82 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.62 units on a scale | Standard Deviation 3.94 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.54 units on a scale | Standard Deviation 6.43 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.30 units on a scale | Standard Deviation 2.05 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.43 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.12 units on a scale | Standard Deviation 2.31 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.31 units on a scale | Standard Deviation 6.34 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.26 units on a scale | Standard Deviation 2.61 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.11 units on a scale | Standard Deviation 2.2 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.39 units on a scale | Standard Deviation 2.27 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.48 units on a scale | Standard Deviation 2.83 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.11 units on a scale | Standard Deviation 1.94 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.29 units on a scale | Standard Deviation 2.65 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.36 units on a scale | Standard Deviation 2.68 |
| Naproxen 500 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.42 units on a scale | Standard Deviation 2.77 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.41 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.04 units on a scale | Standard Deviation 4.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.11 units on a scale | Standard Deviation 1.87 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.20 units on a scale | Standard Deviation 1.51 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.32 units on a scale | Standard Deviation 2.05 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.52 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.37 units on a scale | Standard Deviation 2.42 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.50 units on a scale | Standard Deviation 2.61 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.42 units on a scale | Standard Deviation 2.94 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.56 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.53 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.65 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.64 units on a scale | Standard Deviation 233 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.46 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.30 units on a scale | Standard Deviation 1.93 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.56 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.36 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.29 units on a scale | Standard Deviation 2.03 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.09 units on a scale | Standard Deviation 4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.42 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.58 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.71 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -1.06 units on a scale | Standard Deviation 3.09 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -1.07 units on a scale | Standard Deviation 3.49 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.41 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.14 units on a scale | Standard Deviation 1.6 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -1.05 units on a scale | Standard Deviation 2.97 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.24 units on a scale | Standard Deviation 4.84 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.83 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.55 units on a scale | Standard Deviation 2.08 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.99 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -1.01 units on a scale | Standard Deviation 3.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.72 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.33 units on a scale | Standard Deviation 1.55 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.47 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.38 units on a scale | Standard Deviation 3.84 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.49 units on a scale | Standard Deviation 2.85 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.22 units on a scale | Standard Deviation 3.84 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.39 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.71 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.38 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.50 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.08 units on a scale | Standard Deviation 4.86 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.48 units on a scale | Standard Deviation 3.18 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 48 | -0.69 units on a scale | Standard Deviation 3.14 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 4 | -0.11 units on a scale | Standard Deviation 2.8 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Baseline | 2.18 units on a scale | Standard Deviation 5.2 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 24 | -0.50 units on a scale | Standard Deviation 2.73 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 32 | -0.63 units on a scale | Standard Deviation 2.72 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 8 | -0.35 units on a scale | Standard Deviation 2.06 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 16 | -0.50 units on a scale | Standard Deviation 2.47 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 56 | -0.54 units on a scale | Standard Deviation 2.58 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 2 | -0.34 units on a scale | Standard Deviation 1.17 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 40 | -0.73 units on a scale | Standard Deviation 2.91 |
| Celecoxib 100 mg | Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data | Change at Week 12 | -0.44 units on a scale | Standard Deviation 2.21 |
Secondary
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Weeks 24 and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -11.90 change in percent impairment | Standard Deviation 22.32 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -10.30 change in percent impairment | Standard Deviation 23.11 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -11.68 change in percent impairment | Standard Deviation 24.74 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -11.88 change in percent impairment | Standard Deviation 24.85 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -5.51 change in percent impairment | Standard Deviation 26.33 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -4.08 change in percent impairment | Standard Deviation 25.92 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -13.00 change in percent impairment | Standard Deviation 27.34 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -11.33 change in percent impairment | Standard Deviation 27.19 |
| Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -5.31 change in percent impairment | Standard Deviation 28.51 |
| Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -7.35 change in percent impairment | Standard Deviation 29.03 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -16.99 change in percent impairment | Standard Deviation 22.09 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -17.81 change in percent impairment | Standard Deviation 22 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -12.88 change in percent impairment | Standard Deviation 27 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -13.01 change in percent impairment | Standard Deviation 25.91 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -9.33 change in percent impairment | Standard Deviation 22.4 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -8.09 change in percent impairment | Standard Deviation 24.58 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -9.63 change in percent impairment | Standard Deviation 23.68 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -4.25 change in percent impairment | Standard Deviation 42.03 |
| Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -5.81 change in percent impairment | Standard Deviation 22.62 |
| Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -5.93 change in percent impairment | Standard Deviation 22.3 |
Secondary
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -11.90 change in percent impairment | Standard Deviation 22.32 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -11.68 change in percent impairment | Standard Deviation 24.74 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -5.51 change in percent impairment | Standard Deviation 26.33 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -13.00 change in percent impairment | Standard Deviation 27.34 |
| Naproxen 500 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -7.35 change in percent impairment | Standard Deviation 29.03 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -17.81 change in percent impairment | Standard Deviation 22 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -13.01 change in percent impairment | Standard Deviation 25.91 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -9.33 change in percent impairment | Standard Deviation 22.4 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -9.63 change in percent impairment | Standard Deviation 23.68 |
| Celecoxib 100 mg | Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -5.81 change in percent impairment | Standard Deviation 22.62 |
Secondary
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Week 24 and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.88 change in percent work time missed | Standard Deviation 11.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.10 change in percent work time missed | Standard Deviation 11.3 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | 0.04 change in percent work time missed | Standard Deviation 8.16 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.39 change in percent work time missed | Standard Deviation 9.29 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | 0.63 change in percent work time missed | Standard Deviation 6.23 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | 1.08 change in percent work time missed | Standard Deviation 7.57 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | 0.77 change in percent work time missed | Standard Deviation 15.75 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.41 change in percent work time missed | Standard Deviation 16.46 |
| Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | 2.26 change in percent work time missed | Standard Deviation 13.76 |
| Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | 1.11 change in percent work time missed | Standard Deviation 12.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -3.06 change in percent work time missed | Standard Deviation 9.98 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.85 change in percent work time missed | Standard Deviation 10.19 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.46 change in percent work time missed | Standard Deviation 12.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.42 change in percent work time missed | Standard Deviation 12.87 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | 1.51 change in percent work time missed | Standard Deviation 11.21 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | 1.51 change in percent work time missed | Standard Deviation 11.21 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.64 change in percent work time missed | Standard Deviation 9.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.64 change in percent work time missed | Standard Deviation 9.6 |
| Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.61 change in percent work time missed | Standard Deviation 8.36 |
| Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.82 change in percent work time missed | Standard Deviation 7.94 |
Secondary
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -0.88 change in percent work time missed | Standard Deviation 11.54 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | 0.04 change in percent work time missed | Standard Deviation 8.16 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | 0.63 change in percent work time missed | Standard Deviation 6.23 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -0.77 change in percent work time missed | Standard Deviation 15.75 |
| Naproxen 500 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | 1.11 change in percent work time missed | Standard Deviation 12.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -2.85 change in percent work time missed | Standard Deviation 10.19 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -0.42 change in percent work time missed | Standard Deviation 12.87 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | 1.51 change in percent work time missed | Standard Deviation 11.21 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -1.64 change in percent work time missed | Standard Deviation 9.6 |
| Celecoxib 100 mg | Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -0.61 change in percent work time missed | Standard Deviation 8.36 |
Secondary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.63 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.69 units on a scale | Standard Deviation 1.02 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.45 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.60 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.63 units on a scale | Standard Deviation 0.93 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.67 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.60 units on a scale | Standard Deviation 0.97 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.53 units on a scale | Standard Deviation 1 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.58 units on a scale | Standard Deviation 0.98 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.53 units on a scale | Standard Deviation 0.99 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.74 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.68 units on a scale | Standard Deviation 1 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.77 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.42 units on a scale | Standard Deviation 0.83 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.60 units on a scale | Standard Deviation 0.98 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.60 units on a scale | Standard Deviation 0.98 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.66 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.72 units on a scale | Standard Deviation 0.82 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.55 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.79 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.64 units on a scale | Standard Deviation 0.87 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.75 units on a scale | Standard Deviation 0.88 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.51 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.60 units on a scale | Standard Deviation 0.93 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.49 units on a scale | Standard Deviation 0.94 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.53 units on a scale | Standard Deviation 0.93 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.72 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.50 units on a scale | Standard Deviation 0.81 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.78 units on a scale | Standard Deviation 0.9 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.76 units on a scale | Standard Deviation 0.86 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.46 units on a scale | Standard Deviation 1.09 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.69 units on a scale | Standard Deviation 1.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.68 units on a scale | Standard Deviation 1.16 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.91 units on a scale | Standard Deviation 1.04 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.72 units on a scale | Standard Deviation 0.9 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.56 units on a scale | Standard Deviation 1.1 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.48 units on a scale | Standard Deviation 1.09 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.79 units on a scale | Standard Deviation 1.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.86 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.40 units on a scale | Standard Deviation 0.92 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.48 units on a scale | Standard Deviation 0.83 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.49 units on a scale | Standard Deviation 0.91 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.47 units on a scale | Standard Deviation 0.89 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.50 units on a scale | Standard Deviation 0.91 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.39 units on a scale | Standard Deviation 0.71 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.44 units on a scale | Standard Deviation 0.8 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.49 units on a scale | Standard Deviation 0.93 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.57 units on a scale | Standard Deviation 0.81 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.57 units on a scale | Standard Deviation 0.89 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.57 units on a scale | Standard Deviation 0.96 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.51 units on a scale | Standard Deviation 1.01 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.76 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.61 units on a scale | Standard Deviation 1.03 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.70 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.63 units on a scale | Standard Deviation 1.02 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.77 units on a scale | Standard Deviation 0.9 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.68 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.53 units on a scale | Standard Deviation 1.04 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.46 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.66 units on a scale | Standard Deviation 0.96 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.67 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.62 units on a scale | Standard Deviation 0.91 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.73 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.76 units on a scale | Standard Deviation 0.93 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.56 units on a scale | Standard Deviation 0.85 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.84 units on a scale | Standard Deviation 0.89 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.33 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.66 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.69 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.74 units on a scale | Standard Deviation 0.87 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.73 units on a scale | Standard Deviation 0.91 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.81 units on a scale | Standard Deviation 0.94 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.45 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.81 units on a scale | Standard Deviation 0.95 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.80 units on a scale | Standard Deviation 0.96 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.61 units on a scale | Standard Deviation 1 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.59 units on a scale | Standard Deviation 1 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.73 units on a scale | Standard Deviation 1.02 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.63 units on a scale | Standard Deviation 0.98 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.78 units on a scale | Standard Deviation 0.95 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.77 units on a scale | Standard Deviation 0.96 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.26 units on a scale | Standard Deviation 0.85 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.58 units on a scale | Standard Deviation 1.02 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.59 units on a scale | Standard Deviation 1.01 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.66 units on a scale | Standard Deviation 1 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.81 units on a scale | Standard Deviation 0.85 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.74 units on a scale | Standard Deviation 0.86 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.77 units on a scale | Standard Deviation 0.94 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.66 units on a scale | Standard Deviation 1.01 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.86 units on a scale | Standard Deviation 0.93 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -0.54 units on a scale | Standard Deviation 0.95 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -0.54 units on a scale | Standard Deviation 0.96 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -0.59 units on a scale | Standard Deviation 0.93 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -0.57 units on a scale | Standard Deviation 0.88 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -0.57 units on a scale | Standard Deviation 0.94 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.37 units on a scale | Standard Deviation 0.75 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -0.54 units on a scale | Standard Deviation 0.9 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -0.54 units on a scale | Standard Deviation 0.92 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -0.57 units on a scale | Standard Deviation 0.92 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.51 units on a scale | Standard Deviation 0.85 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.46995% CI: [-0.08, 0.17]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38795% CI: [-0.18, 0.07]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88795% CI: [-0.11, 0.13]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.01, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01895% CI: [0.03, 0.29]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.78395% CI: [-0.11, 0.15]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.76295% CI: [-0.11, 0.15]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01795% CI: [0.03, 0.29]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09195% CI: [-0.23, 0.02]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00995% CI: [-0.29, -0.04]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.83595% CI: [-0.13, 0.11]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.46395% CI: [-0.08, 0.17]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.71395% CI: [-0.16, 0.11]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.26795% CI: [-0.21, 0.06]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.55295% CI: [-0.17, 0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88595% CI: [-0.12, 0.14]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.4795% CI: [-0.26, 0]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05695% CI: [-0.26, 0]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.11795% CI: [-0.24, 0.03]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.10695% CI: [-0.24, 0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.67395% CI: [-0.16, 0.1]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08995% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06595% CI: [-0.26, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.56795% CI: [-0.17, 0.09]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.13595% CI: [-0.24, 0.03]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09495% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05595% CI: [-0.27, 0]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08795% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.54295% CI: [-0.18, 0.1]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.64395% CI: [-0.17, 0.11]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.30195% CI: [-0.21, 0.07]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.23795% CI: [-0.22, 0.05]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.3695% CI: [-0.18, 0.06]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.85495% CI: [-0.13, 0.11]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07695% CI: [-0.23, 0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.95795% CI: [-0.12, 0.12]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40495% CI: [-0.19, 0.08]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.12895% CI: [-0.03, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.57795% CI: [-0.17, 0.09]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06895% CI: [-0.01, 0.25]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01695% CI: [-0.27, -0.03]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.38, -0.13]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.44, -0.19]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.39, -0.15]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03795% CI: [-0.27, -0.01]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01595% CI: [-0.3, -0.03]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00195% CI: [-0.35, -0.08]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.34, -0.07]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04295% CI: [-0.27, 0]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.4, -0.14]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.4, -0.13]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.5, -0.24]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18295% CI: [-0.22, 0.04]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.0895% CI: [-0.25, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.34, -0.07]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.37, -0.11]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01695% CI: [-0.3, -0.03]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.4, -0.13]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.42, -0.15]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.53, -0.27]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03295% CI: [-0.29, -0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00695% CI: [-0.33, -0.06]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00995% CI: [-0.32, -0.05]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.41, -0.13]ANCOVA
Secondary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.60 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.58 units on a scale | Standard Deviation 0.97 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.45 units on a scale | Standard Deviation 0.8 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.58 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.60 units on a scale | Standard Deviation 0.78 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.54 units on a scale | Standard Deviation 0.93 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.69 units on a scale | Standard Deviation 0.81 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.70 units on a scale | Standard Deviation 0.84 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.42 units on a scale | Standard Deviation 0.83 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.68 units on a scale | Standard Deviation 0.85 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.74 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.50 units on a scale | Standard Deviation 0.82 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.50 units on a scale | Standard Deviation 0.81 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.69 units on a scale | Standard Deviation 0.88 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.69 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.84 units on a scale | Standard Deviation 0.99 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.40 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.60 units on a scale | Standard Deviation 0.99 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.68 units on a scale | Standard Deviation 0.87 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.82 units on a scale | Standard Deviation 0.9 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.43 units on a scale | Standard Deviation 0.8 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.49 units on a scale | Standard Deviation 0.82 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.46 units on a scale | Standard Deviation 0.89 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.39 units on a scale | Standard Deviation 0.71 |
| Naproxen 500 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.45 units on a scale | Standard Deviation 0.81 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.63 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.46 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.68 units on a scale | Standard Deviation 0.88 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.71 units on a scale | Standard Deviation 0.86 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.57 units on a scale | Standard Deviation 0.89 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.75 units on a scale | Standard Deviation 0.92 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.75 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.59 units on a scale | Standard Deviation 0.82 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.33 units on a scale | Standard Deviation 0.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.69 units on a scale | Standard Deviation 0.85 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.81 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.80 units on a scale | Standard Deviation 0.92 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.77 units on a scale | Standard Deviation 0.93 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.45 units on a scale | Standard Deviation 0.89 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.67 units on a scale | Standard Deviation 0.99 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.26 units on a scale | Standard Deviation 0.85 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.79 units on a scale | Standard Deviation 0.82 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.75 units on a scale | Standard Deviation 0.84 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.83 units on a scale | Standard Deviation 0.89 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.74 units on a scale | Standard Deviation 0.9 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -0.54 units on a scale | Standard Deviation 0.83 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.37 units on a scale | Standard Deviation 0.75 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -0.55 units on a scale | Standard Deviation 0.84 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.49 units on a scale | Standard Deviation 0.85 |
| Celecoxib 100 mg | Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -0.51 units on a scale | Standard Deviation 0.87 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.46995% CI: [-0.08, 0.17]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38795% CI: [-0.18, 0.07]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88795% CI: [-0.11, 0.13]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.01, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01895% CI: [0.03, 0.29]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.78395% CI: [-0.11, 0.15]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.76295% CI: [-0.11, 0.15]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01795% CI: [0.03, 0.29]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.20795% CI: [-0.2, 0.04]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.0295% CI: [-0.27, -0.02]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.94195% CI: [-0.13, 0.12]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.49495% CI: [-0.18, 0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08995% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.46795% CI: [-0.18, 0.08]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.77495% CI: [-0.11, 0.15]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.31595% CI: [-0.06, 0.19]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08895% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.25, 0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06695% CI: [-0.25, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07395% CI: [-0.25, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.68295% CI: [-0.16, 0.1]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01495% CI: [-0.3, -0.03]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02795% CI: [-0.28, -0.02]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18195% CI: [-0.23, 0.04]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.87195% CI: [-0.14, 0.12]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.30195% CI: [-0.21, 0.06]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01395% CI: [-0.3, -0.04]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03195% CI: [-0.28, -0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.87495% CI: [-0.15, 0.13]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.44795% CI: [-0.19, 0.08]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05995% CI: [-0.27, 0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.19695% CI: [-0.23, 0.05]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.3695% CI: [-0.18, 0.06]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.84595% CI: [-0.13, 0.11]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07695% CI: [-0.23, 0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.95795% CI: [-0.12, 0.12]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40495% CI: [-0.19, 0.08]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.12895% CI: [-0.03, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.57795% CI: [-0.17, 0.09]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06895% CI: [-0.01, 0.25]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01195% CI: [-0.28, -0.04]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.36, -0.11]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.43, -0.18]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.36, -0.12]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04395% CI: [-0.27, 0]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00795% CI: [-0.31, -0.05]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.38, -0.12]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.36, -0.1]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07495% CI: [-0.25, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.37, -0.1]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.37, -0.1]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.49, -0.23]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.23695% CI: [-0.21, 0.05]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.11295% CI: [-0.24, 0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.38, -0.11]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.39, -0.12]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05995% CI: [-0.26, 0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.33, -0.07]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00195% CI: [-0.36, -0.09]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.51, -0.24]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05595% CI: [-0.27, 0]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03895% CI: [-0.28, -0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00795% CI: [-0.33, -0.05]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.42, -0.14]ANCOVA
Secondary
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Weeks 24, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -12.30 change in percent activity impairment | Standard Deviation 25.61 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -12.12 change in percent activity impairment | Standard Deviation 25.37 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -15.51 change in percent activity impairment | Standard Deviation 26.17 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -14.77 change in percent activity impairment | Standard Deviation 26.72 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -13.55 change in percent activity impairment | Standard Deviation 26.42 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -12.19 change in percent activity impairment | Standard Deviation 27.03 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -14.96 change in percent activity impairment | Standard Deviation 26.74 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -13.20 change in percent activity impairment | Standard Deviation 26.58 |
| Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -9.32 change in percent activity impairment | Standard Deviation 24.93 |
| Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -10.00 change in percent activity impairment | Standard Deviation 25.92 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -15.39 change in percent activity impairment | Standard Deviation 23.53 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -17.24 change in percent activity impairment | Standard Deviation 25.11 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -15.76 change in percent activity impairment | Standard Deviation 27.09 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -17.84 change in percent activity impairment | Standard Deviation 25.81 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -18.04 change in percent activity impairment | Standard Deviation 25.47 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -18.04 change in percent activity impairment | Standard Deviation 25.93 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -17.31 change in percent activity impairment | Standard Deviation 26.28 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -15.86 change in percent activity impairment | Standard Deviation 26.91 |
| Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 24 | -11.90 change in percent activity impairment | Standard Deviation 26.06 |
| Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF) | Change at Week 56 | -11.19 change in percent activity impairment | Standard Deviation 26.55 |
Secondary
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -12.30 change in percent activity impairment | Standard Deviation 25.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -15.51 change in percent activity impairment | Standard Deviation 26.17 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -13.55 change in percent activity impairment | Standard Deviation 26.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -14.96 change in percent activity impairment | Standard Deviation 26.74 |
| Naproxen 500 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -10.00 change in percent activity impairment | Standard Deviation 25.92 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -17.24 change in percent activity impairment | Standard Deviation 25.11 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -17.84 change in percent activity impairment | Standard Deviation 25.81 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -18.04 change in percent activity impairment | Standard Deviation 25.47 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -17.31 change in percent activity impairment | Standard Deviation 26.28 |
| Celecoxib 100 mg | Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF) | -11.90 change in percent activity impairment | Standard Deviation 26.06 |
Secondary
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Weeks 24 and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -5.40 change in percent work impairment | Standard Deviation 31.08 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -6.08 change in percent work impairment | Standard Deviation 30.2 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -1.46 change in percent work impairment | Standard Deviation 24.95 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -1.88 change in percent work impairment | Standard Deviation 26.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -0.75 change in percent work impairment | Standard Deviation 18.6 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | 0.77 change in percent work impairment | Standard Deviation 22.05 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -1.35 change in percent work impairment | Standard Deviation 29.85 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -0.85 change in percent work impairment | Standard Deviation 31.85 |
| Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | 4.11 change in percent work impairment | Standard Deviation 27.38 |
| Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | 2.09 change in percent work impairment | Standard Deviation 28.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -10.32 change in percent work impairment | Standard Deviation 26.52 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -10.17 change in percent work impairment | Standard Deviation 26.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -1.01 change in percent work impairment | Standard Deviation 23.22 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -0.22 change in percent work impairment | Standard Deviation 22.51 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | 1.25 change in percent work impairment | Standard Deviation 26.81 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | 1.25 change in percent work impairment | Standard Deviation 26.81 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -4.30 change in percent work impairment | Standard Deviation 24.16 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -4.30 change in percent work impairment | Standard Deviation 24.16 |
| Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 24 | -2.29 change in percent work impairment | Standard Deviation 23.87 |
| Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF | Change at Week 56 | -3.02 change in percent work impairment | Standard Deviation 21.6 |
Secondary
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+\[(1-Q2/(Q2+Q4))\*(Q5/10)\]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Time frame: Baseline, Week 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -5.40 change in percent work impairment | Standard Deviation 31.08 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -1.46 change in percent work impairment | Standard Deviation 24.95 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -0.75 change in percent work impairment | Standard Deviation 18.6 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -1.35 change in percent work impairment | Standard Deviation 29.85 |
| Naproxen 500 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | 2.09 change in percent work impairment | Standard Deviation 28.55 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -10.17 change in percent work impairment | Standard Deviation 26.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -0.22 change in percent work impairment | Standard Deviation 22.51 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | 1.25 change in percent work impairment | Standard Deviation 26.81 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -4.30 change in percent work impairment | Standard Deviation 24.16 |
| Celecoxib 100 mg | Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF | -2.29 change in percent work impairment | Standard Deviation 23.87 |
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.84 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.66 units on a scale | Standard Deviation 2.09 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.94 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.90 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.04 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.00 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.86 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.96 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.04 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.76 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.94 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.08 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.92 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.00 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.86 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.20 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.14 units on a scale | Standard Deviation 2.24 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.93 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.19 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.12 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.20 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.86 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.45 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.84 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.12 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.10 units on a scale | Standard Deviation 2.32 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.27 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.36 units on a scale | Standard Deviation 2.2 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.88 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.03 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.36 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.08 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.56 units on a scale | Standard Deviation 2.35 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.89 units on a scale | Standard Deviation 2.21 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.56 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.12 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.33 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.05 units on a scale | Standard Deviation 2.24 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.33 units on a scale | Standard Deviation 2.39 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.15 units on a scale | Standard Deviation 2.12 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.54 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.44 units on a scale | Standard Deviation 2.22 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.40 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.17 units on a scale | Standard Deviation 2.16 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.32 units on a scale | Standard Deviation 2.26 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.81 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.36 units on a scale | Standard Deviation 2.34 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.62 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.44 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.01 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.86 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.27 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.98 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.76 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.92 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.05 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.29 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.83 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.02 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.93 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.74 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.73 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.07 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.32 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.23 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.25 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.14 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.99 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.72 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.08 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.04 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.20 units on a scale | Standard Deviation 2.61 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.32 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.05 units on a scale | Standard Deviation 2.58 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.34 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.22 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.21 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.98 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.92 units on a scale | Standard Deviation 2.55 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.14 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.39 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.46 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.02 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.18 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.51 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.34 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.03 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.00 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.22 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.45 units on a scale | Standard Deviation 2.25 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.10 units on a scale | Standard Deviation 1.94 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.69 units on a scale | Standard Deviation 2.23 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.40 units on a scale | Standard Deviation 2.05 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.93 units on a scale | Standard Deviation 1.66 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.62 units on a scale | Standard Deviation 2.24 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.54 units on a scale | Standard Deviation 2.22 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.48 units on a scale | Standard Deviation 2.27 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.17 units on a scale | Standard Deviation 2.06 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.50 units on a scale | Standard Deviation 2.17 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.79895% CI: [-0.36, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.77995% CI: [-0.37, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05795% CI: [-0.64, 0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.92795% CI: [-0.31, 0.34]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.9895% CI: [-0.33, 0.32]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09895% CI: [-0.6, 0.05]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.70995% CI: [-0.26, 0.38]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04595% CI: [0.01, 0.65]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.91995% CI: [-0.36, 0.33]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18395% CI: [-0.11, 0.58]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.50495% CI: [-0.46, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.7195% CI: [-0.28, 0.41]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.15295% CI: [-0.09, 0.59]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.57295% CI: [-0.44, 0.24]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33795% CI: [-0.51, 0.18]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.29995% CI: [-0.16, 0.52]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00595% CI: [-0.82, -0.14]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.05, -0.38]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.25, -0.57]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.23, -0.56]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.17795% CI: [-0.57, 0.1]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01495% CI: [-0.76, -0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.28695% CI: [-0.52, 0.15]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.95295% CI: [-0.33, 0.35]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.95, -0.21]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.94, -0.2]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.26, -0.52]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.55]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.97295% CI: [-0.36, 0.38]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09695% CI: [-0.69, 0.06]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06995% CI: [-0.72, 0.03]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.90295% CI: [-0.39, 0.35]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.93, -0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.33, -0.61]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.38, -0.66]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.55, -0.84]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02895% CI: [-0.75, -0.04]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01395% CI: [-0.81, -0.09]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.21795% CI: [-0.58, 0.13]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.35195% CI: [-0.53, 0.19]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.05, -0.28]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.22, -0.45]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.38, -0.62]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.57, -0.8]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38995% CI: [-0.55, 0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08795% CI: [-0.72, 0.05]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07295% CI: [-0.74, 0.03]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.3495% CI: [-0.57, 0.2]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.06, -0.33]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.11, -0.39]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.42, -0.69]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.59, -0.87]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.76295% CI: [-0.42, 0.31]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05695% CI: [-0.72, 0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.0195% CI: [-0.84, -0.12]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33595% CI: [-0.54, 0.19]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.18, -0.38]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.24, -0.44]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.25, -0.46]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.52, -0.73]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.78295% CI: [-0.46, 0.34]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.71995% CI: [-0.47, 0.33]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.15895% CI: [-0.69, 0.11]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18395% CI: [-0.67, 0.13]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00495% CI: [-0.9, -0.18]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.05, -0.33]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.2, 0.48]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.48, -0.76]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40895% CI: [-0.51, 0.21]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09795% CI: [-0.67, 0.06]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01895% CI: [-0.79, -0.07]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.13295% CI: [-0.64, 0.08]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.00195% CI: [-1.08, -0.26]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.00295% CI: [-1.07, -0.25]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: <0.00195% CI: [-1.19, -0.37]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: <0.00195% CI: [-1.37, -0.55]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.95995% CI: [-0.4, 0.42]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.61895% CI: [-0.51, 0.31]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.14995% CI: [-0.71, 0.11]ANCOVA
Comparison: Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariatesp-value: 0.3795% CI: [-0.6, 0.22]ANCOVA
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.86 units on a scale | Standard Deviation 2.32 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.65 units on a scale | Standard Deviation 2.33 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.96 units on a scale | Standard Deviation 1.98 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.68 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.68 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.82 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.87 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.08 units on a scale | Standard Deviation 2.14 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.00 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.95 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.09 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.83 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.27 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.26 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.10 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.34 units on a scale | Standard Deviation 2.35 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.89 units on a scale | Standard Deviation 2.21 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.95 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.98 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.18 units on a scale | Standard Deviation 2.26 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.14 units on a scale | Standard Deviation 2.09 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.32 units on a scale | Standard Deviation 2.15 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.23 units on a scale | Standard Deviation 2.12 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.81 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.13 units on a scale | Standard Deviation 2.08 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.83 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.01 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.69 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.15 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.81 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.78 units on a scale | Standard Deviation 2.06 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.20 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.04 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.74 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.01 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.23 units on a scale | Standard Deviation 2.22 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.07 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.28 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.08 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.10 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.36 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.03 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.47 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.29 units on a scale | Standard Deviation 2.56 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.40 units on a scale | Standard Deviation 1.96 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.93 units on a scale | Standard Deviation 1.66 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.63 units on a scale | Standard Deviation 2.07 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.09 units on a scale | Standard Deviation 1.94 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.15 units on a scale | Standard Deviation 2.03 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.92795% CI: [-0.31, 0.34]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05795% CI: [-0.64, 0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.77995% CI: [-0.37, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.79895% CI: [-0.36, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.9895% CI: [-0.33, 0.32]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09895% CI: [-0.6, 0.05]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.70995% CI: [-0.26, 0.38]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04595% CI: [0.01, 0.65]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.7195% CI: [-0.28, 0.41]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.50495% CI: [-0.46, 0.23]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18395% CI: [-0.11, 0.58]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.91995% CI: [-0.36, 0.33]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.15295% CI: [-0.09, 0.59]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.57295% CI: [-0.44, 0.24]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33795% CI: [-0.51, 0.18]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.29995% CI: [-0.16, 0.52]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.17, -0.5]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.22, -0.55]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.01, -0.34]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.85, -0.18]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.34195% CI: [-0.5, 0.17]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03195% CI: [-0.71, -0.03]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.34995% CI: [-0.49, 0.17]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.7895% CI: [-0.29, 0.38]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.31, -0.58]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.56]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.99, -0.26]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00595% CI: [-0.88, -0.15]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.56295% CI: [-0.47, 0.26]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02895% CI: [-0.77, -0.04]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.68, 0.04]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.9195% CI: [-0.38, 0.34]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.4, -0.69]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.27, -0.56]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.25, -0.55]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.88, -0.17]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03995% CI: [-0.72, -0.02]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03295% CI: [-0.74, -0.03]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40995% CI: [-0.5, 0.2]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.46195% CI: [-0.49, 0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.59, -0.84]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.4, -0.65]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.17, -0.43]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.97, -0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.28195% CI: [-0.58, 0.17]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02395% CI: [-0.81, -0.06]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03195% CI: [-0.79, -0.04]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33195% CI: [-0.56, 0.19]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.47, -0.75]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.33, -0.6]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.03, -0.31]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.98, -0.26]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.78195% CI: [-0.41, 0.31]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05795% CI: [-0.71, 0.01]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01695% CI: [-0.8, -0.08]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.4595% CI: [-0.5, 0.22]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.47, -0.69]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.2, -0.42]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.12, -0.34]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00195% CI: [-1.04, -0.26]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.69995% CI: [-0.47, 0.31]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40895% CI: [-0.55, 0.22]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07795% CI: [-0.74, 0.04]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.18295% CI: [-0.65, 0.12]ANCOVA
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.69 units on a scale | Standard Deviation 2.23 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.82 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.82 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.87 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.10 units on a scale | Standard Deviation 1.88 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.46 units on a scale | Standard Deviation 1.72 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.87 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.04 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.02 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.70 units on a scale | Standard Deviation 2.02 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.84 units on a scale | Standard Deviation 1.87 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.47 units on a scale | Standard Deviation 1.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.84 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.13 units on a scale | Standard Deviation 1.9 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.93 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.13 units on a scale | Standard Deviation 2.06 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.90 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.08 units on a scale | Standard Deviation 2.12 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.01 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.44 units on a scale | Standard Deviation 2.02 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.57 units on a scale | Standard Deviation 1.67 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.08 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.23 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.40 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.22 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.15 units on a scale | Standard Deviation 2.32 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.95 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.90 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.88 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.06 units on a scale | Standard Deviation 2.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.29 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.06 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.39 units on a scale | Standard Deviation 1.62 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.96 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.50 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.87 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.04 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.25 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.33 units on a scale | Standard Deviation 2.21 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.31 units on a scale | Standard Deviation 2.11 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.69 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.11 units on a scale | Standard Deviation 1.95 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.44 units on a scale | Standard Deviation 2.23 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.49 units on a scale | Standard Deviation 2.22 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.04 units on a scale | Standard Deviation 1.91 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.34 units on a scale | Standard Deviation 2.22 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.53 units on a scale | Standard Deviation 2.29 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.32 units on a scale | Standard Deviation 1.62 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.39 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.08 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.02 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.35 units on a scale | Standard Deviation 2.48 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.18 units on a scale | Standard Deviation 2.01 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.90 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.14 units on a scale | Standard Deviation 2.42 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.06 units on a scale | Standard Deviation 2.48 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.67 units on a scale | Standard Deviation 1.6 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.94 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.81 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.16 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.08 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.24 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.31 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.95 units on a scale | Standard Deviation 1.99 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.75 units on a scale | Standard Deviation 2.1 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.04 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.58 units on a scale | Standard Deviation 1.58 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.78 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.97 units on a scale | Standard Deviation 2.42 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.03 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.13 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.22 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.95 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.92 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.21 units on a scale | Standard Deviation 1.96 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.00 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.20 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.57 units on a scale | Standard Deviation 1.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.37 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.50 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.05 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.91 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.29 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.18 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.20 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.05 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.44 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.39 units on a scale | Standard Deviation 1.62 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.62 units on a scale | Standard Deviation 2.22 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Baseline | 6.47 units on a scale | Standard Deviation 1.59 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.67 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.57 units on a scale | Standard Deviation 2.23 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.52 units on a scale | Standard Deviation 2.24 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.14 units on a scale | Standard Deviation 1.96 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.44 units on a scale | Standard Deviation 2.23 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.45 units on a scale | Standard Deviation 2.24 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.09 units on a scale | Standard Deviation 1.83 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.36 units on a scale | Standard Deviation 2.05 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88795% CI: [-0.33, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04695% CI: [-0.62, -0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.77195% CI: [-0.26, 0.35]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03295% CI: [0.03, 0.64]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.22395% CI: [-0.13, 0.54]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.71895% CI: [-0.39, 0.27]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.49595% CI: [-0.45, 0.22]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38995% CI: [-0.47, 0.18]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03595% CI: [-0.68, -0.02]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.15595% CI: [-0.56, 0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.87695% CI: [-0.35, 0.3]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.86495% CI: [-0.33, 0.39]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33895% CI: [-0.54, 0.18]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.10195% CI: [-0.66, 0.06]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.60595% CI: [-0.46, 0.27]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01395% CI: [-0.78, -0.09]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00595% CI: [-0.84, -0.15]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.19995% CI: [-0.57, 0.12]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.36395% CI: [-0.5, 0.18]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.61395% CI: [-0.47, 0.28]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.41695% CI: [-0.53, 0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.14395% CI: [-0.66, 0.09]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.24595% CI: [-0.6, 0.15]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.74595% CI: [-0.41, 0.29]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.06295% CI: [-0.69, 0.02]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01495% CI: [-0.8, -0.09]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.36795% CI: [-0.52, 0.19]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.99595% CI: [-0.39, 0.39]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.73595% CI: [-0.46, 0.32]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.16995% CI: [-0.67, 0.12]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.29595% CI: [-0.6, 0.18]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.28495% CI: [-0.47, 0.14]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.22495% CI: [-0.5, 0.12]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.79, -0.17]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.35595% CI: [-0.45, 0.16]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.17295% CI: [-0.57, 0.1]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88295% CI: [-0.36, 0.31]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.63, 0.04]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40595% CI: [-0.47, 0.19]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.94, -0.3]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.09, -0.44]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.3, -0.64]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.32, -0.67]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.02, -0.3]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.99, -0.27]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.19, -0.48]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.57]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.89, -0.2]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.32, -0.63]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.39, -0.7]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.55, -0.86]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.18, -0.43]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.28, -0.53]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.33, -0.58]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.56, -0.81]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.02, -0.31]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.08, -0.37]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.36, -0.65]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.52, -0.81]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.51]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.3, -0.51]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.36, -0.58]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.0195% CI: [-1.57, -0.79]ANCOVA
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time frame: Baseline, Weeks 2, 4, 8, 12, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.85 units on a scale | Standard Deviation 2.25 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.66 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.10 units on a scale | Standard Deviation 1.88 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.62 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.71 units on a scale | Standard Deviation 2 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.76 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.79 units on a scale | Standard Deviation 1.88 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.01 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.13 units on a scale | Standard Deviation 1.9 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.87 units on a scale | Standard Deviation 2.06 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.04 units on a scale | Standard Deviation 2.16 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.76 units on a scale | Standard Deviation 2.11 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.44 units on a scale | Standard Deviation 2.02 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.18 units on a scale | Standard Deviation 2.17 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.05 units on a scale | Standard Deviation 2.26 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.29 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.06 units on a scale | Standard Deviation 2.07 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.96 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.00 units on a scale | Standard Deviation 2.06 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.19 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.01 units on a scale | Standard Deviation 1.9 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.30 units on a scale | Standard Deviation 2.03 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.23 units on a scale | Standard Deviation 2 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.69 |
| Naproxen 500 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.07 units on a scale | Standard Deviation 1.87 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.89 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.18 units on a scale | Standard Deviation 2.01 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.73 units on a scale | Standard Deviation 2.23 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.23 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.92 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.78 units on a scale | Standard Deviation 2.06 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.13 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.00 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.95 units on a scale | Standard Deviation 1.99 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.00 units on a scale | Standard Deviation 2.17 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.97 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.34 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.21 units on a scale | Standard Deviation 1.96 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.30 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.00 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.46 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.33 units on a scale | Standard Deviation 2.45 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.36 units on a scale | Standard Deviation 1.97 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.90 units on a scale | Standard Deviation 1.67 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.57 units on a scale | Standard Deviation 2.08 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.07 units on a scale | Standard Deviation 1.83 |
| Celecoxib 100 mg | Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.13 units on a scale | Standard Deviation 1.94 |
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88795% CI: [-0.33, 0.28]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.04695% CI: [-0.62, -0.01]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.77195% CI: [-0.26, 0.35]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03295% CI: [0.03, 0.64]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.22395% CI: [-0.13, 0.54]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.71895% CI: [-0.39, 0.27]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.49595% CI: [-0.45, 0.22]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.37195% CI: [-0.18, 0.49]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.64795% CI: [-0.4, 0.25]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.07395% CI: [-0.62, 0.03]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.16195% CI: [-0.55, 0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.96195% CI: [-0.33, 0.32]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.69795% CI: [-0.42, 0.28]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.13995% CI: [-0.62, 0.09]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.1295% CI: [-0.64, 0.07]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.63795% CI: [-0.44, 0.27]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02895% CI: [-0.72, -0.04]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.02495% CI: [-0.74, -0.05]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33995% CI: [-0.51, 0.17]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.38195% CI: [-0.5, 0.19]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.43895% CI: [-0.51, 0.22]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.11195% CI: [-0.66, 0.07]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.05995% CI: [-0.72, 0.01]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.28295% CI: [-0.57, 0.17]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.92795% CI: [-0.37, 0.33]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.09495% CI: [-0.65, 0.05]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.01295% CI: [-0.8, -0.1]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.36395% CI: [-0.51, 0.19]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.74295% CI: [-0.32, 0.45]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.43695% CI: [-0.53, 0.23]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.03895% CI: [-0.79, -0.02]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.33295% CI: [-0.57, 0.19]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.28495% CI: [-0.47, 0.14]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.22495% CI: [-0.5, 0.12]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00295% CI: [-0.79, -0.17]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.35595% CI: [-0.45, 0.16]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.17295% CI: [-0.57, 0.1]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.88295% CI: [-0.36, 0.31]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.08495% CI: [-0.63, 0.04]ANCOVA
Comparison: Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.40595% CI: [-0.47, 0.19]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.99, -0.34]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.06, -0.42]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.64]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.29, -0.65]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-0.95, -0.25]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.02, -0.32]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.22, -0.51]ANCOVA
Comparison: Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.31, -0.6]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00395% CI: [-0.86, -0.18]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.24, -0.56]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.26, -0.57]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.41, -0.73]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.06, -0.33]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.21, -0.47]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.36, -0.63]ANCOVA
Comparison: Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.56, -0.83]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: 0.00195% CI: [-0.93, -0.23]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.24, -0.53]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.24, -0.53]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.4, -0.7]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.17, -0.4]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.11, -0.34]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.32, -0.56]ANCOVA
Comparison: Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.p-value: <0.00195% CI: [-1.51, -0.75]ANCOVA
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.08 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.89 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.91 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.94 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.74 units on a scale | Standard Deviation 2.06 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.13 units on a scale | Standard Deviation 1.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.96 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.10 units on a scale | Standard Deviation 2.37 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.05 units on a scale | Standard Deviation 2.22 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.78 units on a scale | Standard Deviation 2.26 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.18 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.25 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.15 units on a scale | Standard Deviation 1.86 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.93 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.98 units on a scale | Standard Deviation 1.9 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.02 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.20 units on a scale | Standard Deviation 2.09 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.99 units on a scale | Standard Deviation 2.35 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.24 units on a scale | Standard Deviation 2.16 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.10 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.18 units on a scale | Standard Deviation 2.13 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.46 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.31 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.52 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.48 units on a scale | Standard Deviation 2.17 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.30 units on a scale | Standard Deviation 2.22 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.20 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.99 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.96 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.93 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.13 units on a scale | Standard Deviation 2.13 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.36 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.41 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.04 units on a scale | Standard Deviation 2.03 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.08 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.57 units on a scale | Standard Deviation 2.27 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.99 units on a scale | Standard Deviation 2.32 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.14 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.35 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.58 units on a scale | Standard Deviation 2.32 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.45 units on a scale | Standard Deviation 2.1 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.15 units on a scale | Standard Deviation 1.95 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.37 units on a scale | Standard Deviation 2.14 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.51 units on a scale | Standard Deviation 2.26 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.58 units on a scale | Standard Deviation 2.24 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.20 units on a scale | Standard Deviation 2.01 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.43 units on a scale | Standard Deviation 2.25 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.64 units on a scale | Standard Deviation 2.29 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.93 units on a scale | Standard Deviation 1.69 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.48 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.10 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.40 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.31 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.87 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.90 units on a scale | Standard Deviation 2.33 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.16 units on a scale | Standard Deviation 2.41 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.05 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.17 units on a scale | Standard Deviation 2.05 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.94 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.03 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.20 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.37 units on a scale | Standard Deviation 2.55 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.28 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.29 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.84 units on a scale | Standard Deviation 2.12 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.07 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.98 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.81 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.00 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.10 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.40 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.30 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.22 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.98 units on a scale | Standard Deviation 2.46 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.06 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.05 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.22 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.23 units on a scale | Standard Deviation 1.94 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.36 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.53 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.08 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.41 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.59 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.20 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.07 units on a scale | Standard Deviation 2.23 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.22 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.07 units on a scale | Standard Deviation 2.48 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.46 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.99 units on a scale | Standard Deviation 2.12 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.58 units on a scale | Standard Deviation 2.13 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.89 units on a scale | Standard Deviation 1.65 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.07 units on a scale | Standard Deviation 1.85 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.53 units on a scale | Standard Deviation 2.15 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.49 units on a scale | Standard Deviation 2.16 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.33 units on a scale | Standard Deviation 1.97 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.40 units on a scale | Standard Deviation 2.16 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.42 units on a scale | Standard Deviation 2.18 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.16 units on a scale | Standard Deviation 1.94 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.45 units on a scale | Standard Deviation 2.03 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.13 units on a scale | Standard Deviation 1.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.68 units on a scale | Standard Deviation 2.21 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.74 units on a scale | Standard Deviation 2.04 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.90 units on a scale | Standard Deviation 2.26 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.45 units on a scale | Standard Deviation 1.62 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.70 units on a scale | Standard Deviation 2.29 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.84 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.98 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.84 units on a scale | Standard Deviation 2.19 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.15 units on a scale | Standard Deviation 1.86 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.92 units on a scale | Standard Deviation 1.91 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.98 units on a scale | Standard Deviation 2.08 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.54 units on a scale | Standard Deviation 1.53 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.11 units on a scale | Standard Deviation 2.05 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.14 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.15 units on a scale | Standard Deviation 2.15 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.60 units on a scale | Standard Deviation 1.58 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.87 units on a scale | Standard Deviation 2.17 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.17 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.46 units on a scale | Standard Deviation 2.03 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.31 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.04 units on a scale | Standard Deviation 2.03 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.38 units on a scale | Standard Deviation 1.63 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.06 units on a scale | Standard Deviation 2.11 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.22 units on a scale | Standard Deviation 2.2 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.35 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.28 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.99 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.27 units on a scale | Standard Deviation 2.02 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.93 units on a scale | Standard Deviation 1.69 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.13 units on a scale | Standard Deviation 1.91 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.41 units on a scale | Standard Deviation 1.51 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.34 units on a scale | Standard Deviation 2.06 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.34 units on a scale | Standard Deviation 1.99 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.15 units on a scale | Standard Deviation 1.94 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.90 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.13 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.93 units on a scale | Standard Deviation 2.3 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.79 units on a scale | Standard Deviation 2.3 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.60 units on a scale | Standard Deviation 1.58 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.17 units on a scale | Standard Deviation 2.05 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.26 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.08 units on a scale | Standard Deviation 2.22 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.05 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.17 units on a scale | Standard Deviation 2.35 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.54 units on a scale | Standard Deviation 1.54 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.24 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.98 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.87 units on a scale | Standard Deviation 2.07 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.08 units on a scale | Standard Deviation 2.2 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.23 units on a scale | Standard Deviation 1.94 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.23 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.09 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.35 units on a scale | Standard Deviation 2.36 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.48 units on a scale | Standard Deviation 1.7 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.30 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.33 units on a scale | Standard Deviation 1.59 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.10 units on a scale | Standard Deviation 2.17 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.48 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.55 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.42 units on a scale | Standard Deviation 2.25 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.99 units on a scale | Standard Deviation 2.12 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.33 units on a scale | Standard Deviation 2.42 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.53 units on a scale | Standard Deviation 2 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.14 units on a scale | Standard Deviation 1.91 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.89 units on a scale | Standard Deviation 1.65 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.42 units on a scale | Standard Deviation 1.94 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.38 units on a scale | Standard Deviation 1.55 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.33 units on a scale | Standard Deviation 1.89 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.06 units on a scale | Standard Deviation 1.85 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.29 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.00 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.99 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.06 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.80 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.29 units on a scale | Standard Deviation 2.23 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.12 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.26 units on a scale | Standard Deviation 2.73 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.23 units on a scale | Standard Deviation 2.63 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.90 units on a scale | Standard Deviation 2.55 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.38 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.48 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.34 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.08 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.20 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.17 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.40 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.21 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.47 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.28 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.51 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.67 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.62 units on a scale | Standard Deviation 2.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.76 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.70 units on a scale | Standard Deviation 2.45 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.48 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.43 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.09 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.10 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.10 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.41 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.66 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.75 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.36 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.29 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.88 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.24 units on a scale | Standard Deviation 2.7 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.41 units on a scale | Standard Deviation 2.8 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.62 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.94 units on a scale | Standard Deviation 2.65 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.63 units on a scale | Standard Deviation 2.46 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.26 units on a scale | Standard Deviation 2.39 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.47 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.51 units on a scale | Standard Deviation 2.45 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.74 units on a scale | Standard Deviation 2.53 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.35 units on a scale | Standard Deviation 2.37 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.43 units on a scale | Standard Deviation 2.45 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.70 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.94 units on a scale | Standard Deviation 2.19 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.48 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.27 units on a scale | Standard Deviation 2.8 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.64 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.62 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.14 units on a scale | Standard Deviation 2.68 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.16 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.35 units on a scale | Standard Deviation 2.84 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.31 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.41 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.20 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.27 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.50 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.69 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.57 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.53 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.05 units on a scale | Standard Deviation 2.39 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.37 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.28 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.23 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.98 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.24 units on a scale | Standard Deviation 2.84 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.30 units on a scale | Standard Deviation 2.91 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.57 units on a scale | Standard Deviation 2.81 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.52 units on a scale | Standard Deviation 2.98 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.50 units on a scale | Standard Deviation 2.67 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.16 units on a scale | Standard Deviation 2.89 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.43 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.26 units on a scale | Standard Deviation 2.95 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.60 units on a scale | Standard Deviation 2.99 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.45 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.59 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.89 units on a scale | Standard Deviation 2.75 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.31 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.71 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.90 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.47 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.37 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.55 units on a scale | Standard Deviation 2.9 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.34 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.83 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.37 units on a scale | Standard Deviation 2.18 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.84 units on a scale | Standard Deviation 2.44 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.05 units on a scale | Standard Deviation 2.08 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.30 units on a scale | Standard Deviation 2.2 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.78 units on a scale | Standard Deviation 2.48 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.76 units on a scale | Standard Deviation 2.46 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.55 units on a scale | Standard Deviation 2.17 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.64 units on a scale | Standard Deviation 2.47 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.71 units on a scale | Standard Deviation 2.51 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.35 units on a scale | Standard Deviation 2.08 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.75 units on a scale | Standard Deviation 2.24 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.78 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.09 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.82 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.79 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.29 units on a scale | Standard Deviation 2.23 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.99 units on a scale | Standard Deviation 2.6 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.55 units on a scale | Standard Deviation 1.8 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.01 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.13 units on a scale | Standard Deviation 2.3 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.34 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.32 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.20 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.16 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.68 units on a scale | Standard Deviation 1.78 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.41 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.35 units on a scale | Standard Deviation 2.47 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.49 units on a scale | Standard Deviation 2.57 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.67 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.02 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.46 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.72 units on a scale | Standard Deviation 1.69 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.36 units on a scale | Standard Deviation 2.42 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.50 units on a scale | Standard Deviation 1.73 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.22 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.53 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.53 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.67 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.32 units on a scale | Standard Deviation 2.44 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.34 units on a scale | Standard Deviation 2.27 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.40 units on a scale | Standard Deviation 1.87 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.94 units on a scale | Standard Deviation 2.19 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.22 units on a scale | Standard Deviation 2.38 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.37 units on a scale | Standard Deviation 2.37 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.53 units on a scale | Standard Deviation 2.29 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.51 units on a scale | Standard Deviation 2.28 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.39 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.41 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.17 units on a scale | Standard Deviation 2.63 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.02 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.80 units on a scale | Standard Deviation 1.71 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.05 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.45 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.52 units on a scale | Standard Deviation 2.78 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.59 units on a scale | Standard Deviation 1.77 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.35 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.23 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.28 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.07 units on a scale | Standard Deviation 2.35 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.43 units on a scale | Standard Deviation 2.63 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.48 units on a scale | Standard Deviation 2.56 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.48 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.45 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.47 units on a scale | Standard Deviation 2.9 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.52 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.55 units on a scale | Standard Deviation 1.77 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.76 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.37 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.63 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.65 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.54 units on a scale | Standard Deviation 1.78 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.36 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.79 units on a scale | Standard Deviation 2.64 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.29 units on a scale | Standard Deviation 2.21 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.66 units on a scale | Standard Deviation 2.17 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.73 units on a scale | Standard Deviation 2.33 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.05 units on a scale | Standard Deviation 2.08 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.33 units on a scale | Standard Deviation 2.04 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.50 units on a scale | Standard Deviation 2.1 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 7.52 units on a scale | Standard Deviation 1.7 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.93 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.65 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.63 units on a scale | Standard Deviation 2.81 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.69 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.65 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.05 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.78 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.95 units on a scale | Standard Deviation 2.64 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.93 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.65 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.94 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.09 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.64 units on a scale | Standard Deviation 2.92 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.92 units on a scale | Standard Deviation 2.41 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.72 units on a scale | Standard Deviation 2.92 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.98 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.78 units on a scale | Standard Deviation 2.92 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.00 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.80 units on a scale | Standard Deviation 2.85 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.01 units on a scale | Standard Deviation 2.18 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.31 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.08 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.32 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.20 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.98 units on a scale | Standard Deviation 2.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.91 units on a scale | Standard Deviation 2.61 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.69 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.68 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.68 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.99 units on a scale | Standard Deviation 2.36 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.15 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.87 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.78 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.44 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.73 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.77 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.12 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.41 units on a scale | Standard Deviation 2.57 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.33 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.04 units on a scale | Standard Deviation 2.51 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.20 units on a scale | Standard Deviation 2.54 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.23 units on a scale | Standard Deviation 2.66 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.36 units on a scale | Standard Deviation 2.62 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.07 units on a scale | Standard Deviation 2.45 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.15 units on a scale | Standard Deviation 2.62 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.45 units on a scale | Standard Deviation 2.71 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.80 units on a scale | Standard Deviation 2.08 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.22 units on a scale | Standard Deviation 2.67 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.78 units on a scale | Standard Deviation 2.87 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.11 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.03 units on a scale | Standard Deviation 2.85 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.54 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.61 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.79 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.72 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.04 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.62 units on a scale | Standard Deviation 2.72 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.73 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.80 units on a scale | Standard Deviation 2.99 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.08 units on a scale | Standard Deviation 2.97 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.97 units on a scale | Standard Deviation 2.86 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.98 units on a scale | Standard Deviation 2.81 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.59 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.85 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.75 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.68 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.42 units on a scale | Standard Deviation 2.89 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.64 units on a scale | Standard Deviation 2.92 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.79 units on a scale | Standard Deviation 2.9 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.20 units on a scale | Standard Deviation 2.86 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.96 units on a scale | Standard Deviation 2.89 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.06 units on a scale | Standard Deviation 2.6 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.67 units on a scale | Standard Deviation 2.92 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.84 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.73 units on a scale | Standard Deviation 2.92 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.04 units on a scale | Standard Deviation 2.89 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.01 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.11 units on a scale | Standard Deviation 2.91 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.25 units on a scale | Standard Deviation 2.83 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.74 units on a scale | Standard Deviation 2.98 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.22 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.27 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.89 units on a scale | Standard Deviation 2.95 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.91 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.89 units on a scale | Standard Deviation 3 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.72 units on a scale | Standard Deviation 2.94 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.15 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.51 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.64 units on a scale | Standard Deviation 2.52 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.04 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -0.96 units on a scale | Standard Deviation 2.28 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.56 units on a scale | Standard Deviation 2.48 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.40 units on a scale | Standard Deviation 2.53 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.36 units on a scale | Standard Deviation 2.33 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.33 units on a scale | Standard Deviation 2.6 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.36 units on a scale | Standard Deviation 2.63 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.13 units on a scale | Standard Deviation 2.45 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.42 units on a scale | Standard Deviation 2.41 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.71 units on a scale | Standard Deviation 2.4 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.57 units on a scale | Standard Deviation 2.64 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.22 units on a scale | Standard Deviation 1.83 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.05 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.74 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.56 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.67 units on a scale | Standard Deviation 2.37 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.78 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.95 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.65 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.77 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.37 units on a scale | Standard Deviation 1.97 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.88 units on a scale | Standard Deviation 2.39 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.15 units on a scale | Standard Deviation 2.38 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.34 units on a scale | Standard Deviation 1.87 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.98 units on a scale | Standard Deviation 2.19 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.95 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.93 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.31 units on a scale | Standard Deviation 2.24 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.64 units on a scale | Standard Deviation 2.47 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.92 units on a scale | Standard Deviation 2.34 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.87 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.13 units on a scale | Standard Deviation 1.96 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.19 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.22 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.09 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.83 units on a scale | Standard Deviation 2.51 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.05 units on a scale | Standard Deviation 2.33 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.12 units on a scale | Standard Deviation 2.08 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.20 units on a scale | Standard Deviation 2.33 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.80 units on a scale | Standard Deviation 2.08 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.23 units on a scale | Standard Deviation 2.32 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.04 units on a scale | Standard Deviation 2.47 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.10 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.67 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.28 units on a scale | Standard Deviation 1.83 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.04 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.49 units on a scale | Standard Deviation 2.58 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.04 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.94 units on a scale | Standard Deviation 2.69 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.63 units on a scale | Standard Deviation 2.61 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.84 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.02 units on a scale | Standard Deviation 2.84 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.64 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.91 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.68 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.30 units on a scale | Standard Deviation 1.88 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.88 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.21 units on a scale | Standard Deviation 1.97 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.96 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.20 units on a scale | Standard Deviation 2.73 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.11 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.08 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.88 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.01 units on a scale | Standard Deviation 2.24 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.14 units on a scale | Standard Deviation 1.97 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.06 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.93 units on a scale | Standard Deviation 2.45 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.58 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.22 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.25 units on a scale | Standard Deviation 2.61 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.38 units on a scale | Standard Deviation 2.28 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.55 units on a scale | Standard Deviation 2.33 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.86 units on a scale | Standard Deviation 2.04 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.35 units on a scale | Standard Deviation 2.24 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.11 units on a scale | Standard Deviation 2.4 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.10 units on a scale | Standard Deviation 1.83 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -0.95 units on a scale | Standard Deviation 2.27 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.18 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.99 units on a scale | Standard Deviation 2.86 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.03 units on a scale | Standard Deviation 2.9 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.05 units on a scale | Standard Deviation 2.85 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.88 units on a scale | Standard Deviation 2.49 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.35 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.07 units on a scale | Standard Deviation 2.86 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.22 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.16 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.88 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.36 units on a scale | Standard Deviation 2.5 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.43 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.32 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.10 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.17 units on a scale | Standard Deviation 2.33 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.23 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.39 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.15 units on a scale | Standard Deviation 2.63 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.44 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.23 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.34 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.65 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.44 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.71 units on a scale | Standard Deviation 2.5 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.64 units on a scale | Standard Deviation 2.58 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.48 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.36 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.13 units on a scale | Standard Deviation 2.63 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.11 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.07 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.27 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.46 units on a scale | Standard Deviation 2.81 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.52 units on a scale | Standard Deviation 2.53 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.19 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.20 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.70 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.08 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.24 units on a scale | Standard Deviation 2.76 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.48 units on a scale | Standard Deviation 2.8 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.68 units on a scale | Standard Deviation 2.69 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.58 units on a scale | Standard Deviation 2.35 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.26 units on a scale | Standard Deviation 2.2 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.52 units on a scale | Standard Deviation 2.4 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.69 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.75 units on a scale | Standard Deviation 2.45 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.35 units on a scale | Standard Deviation 2.32 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.63 units on a scale | Standard Deviation 2.49 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.80 units on a scale | Standard Deviation 2.52 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 1.98 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.69 units on a scale | Standard Deviation 2.54 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.18 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.55 units on a scale | Standard Deviation 2.92 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.35 units on a scale | Standard Deviation 2.91 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.04 units on a scale | Standard Deviation 2.71 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.97 units on a scale | Standard Deviation 2.8 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.28 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.10 units on a scale | Standard Deviation 2.83 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.35 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.01 units on a scale | Standard Deviation 2.8 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.15 units on a scale | Standard Deviation 2.75 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.31 units on a scale | Standard Deviation 2.73 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.49 units on a scale | Standard Deviation 2.9 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.37 units on a scale | Standard Deviation 2.66 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.41 units on a scale | Standard Deviation 2.71 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.03 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.30 units on a scale | Standard Deviation 2.62 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.20 units on a scale | Standard Deviation 2.74 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.21 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.94 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.10 units on a scale | Standard Deviation 2.73 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.22 units on a scale | Standard Deviation 2.8 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.49 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.46 units on a scale | Standard Deviation 2.79 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.30 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.10 units on a scale | Standard Deviation 2.76 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.13 units on a scale | Standard Deviation 2.53 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.16 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.23 units on a scale | Standard Deviation 2.78 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.41 units on a scale | Standard Deviation 2.31 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.43 units on a scale | Standard Deviation 2.77 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.68 units on a scale | Standard Deviation 2.72 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.17 units on a scale | Standard Deviation 2.67 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.58 units on a scale | Standard Deviation 2.6 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.76 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -2.26 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.22 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -2.31 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.14 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.55 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.11 units on a scale | Standard Deviation 2.44 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 24 | -1.43 units on a scale | Standard Deviation 2.33 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 2 | -0.82 units on a scale | Standard Deviation 2.04 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.01 units on a scale | Standard Deviation 2.18 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 32 | -1.41 units on a scale | Standard Deviation 2.37 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 40 | -1.43 units on a scale | Standard Deviation 2.47 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.24 units on a scale | Standard Deviation 2.23 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 48 | -1.34 units on a scale | Standard Deviation 2.45 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 56 | -1.34 units on a scale | Standard Deviation 2.47 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.15 units on a scale | Standard Deviation 2.18 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF) | Change at Week 16 | -1.38 units on a scale | Standard Deviation 2.25 |
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.93 units on a scale | Standard Deviation 2.55 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.76 units on a scale | Standard Deviation 2.6 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.50 units on a scale | Standard Deviation 2 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.35 units on a scale | Standard Deviation 2.43 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.98 units on a scale | Standard Deviation 2.64 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.80 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.85 units on a scale | Standard Deviation 2.46 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.14 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.32 units on a scale | Standard Deviation 2.18 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.38 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.96 units on a scale | Standard Deviation 2.52 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.15 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.66 units on a scale | Standard Deviation 1.85 |
| Tanezumab 10 mg (Naproxen Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.10 units on a scale | Standard Deviation 2.34 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.49 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.70 units on a scale | Standard Deviation 1.88 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.31 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.31 units on a scale | Standard Deviation 2.57 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.26 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.65 units on a scale | Standard Deviation 2.44 |
| Tanezumab 5 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.98 units on a scale | Standard Deviation 2.57 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.19 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.19 units on a scale | Standard Deviation 2.29 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.42 units on a scale | Standard Deviation 2.05 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.40 units on a scale | Standard Deviation 2.65 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.42 units on a scale | Standard Deviation 2.69 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.31 units on a scale | Standard Deviation 2.54 |
| Tanezumab 10 mg + Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.04 units on a scale | Standard Deviation 2.74 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.29 units on a scale | Standard Deviation 2.24 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.60 units on a scale | Standard Deviation 1.73 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.46 units on a scale | Standard Deviation 2.28 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.02 units on a scale | Standard Deviation 1.98 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.42 units on a scale | Standard Deviation 2.22 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.23 units on a scale | Standard Deviation 2.17 |
| Naproxen 500 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.40 units on a scale | Standard Deviation 2.27 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.02 units on a scale | Standard Deviation 2.66 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.62 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.35 units on a scale | Standard Deviation 2.52 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.94 units on a scale | Standard Deviation 2.65 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.38 units on a scale | Standard Deviation 2.75 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.14 units on a scale | Standard Deviation 2.74 |
| Tanezumab 5 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.97 units on a scale | Standard Deviation 2.56 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.22 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.36 units on a scale | Standard Deviation 2.87 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.05 units on a scale | Standard Deviation 2.49 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.28 units on a scale | Standard Deviation 2.68 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.21 units on a scale | Standard Deviation 2.4 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.58 units on a scale | Standard Deviation 2.04 |
| Tanezumab 10 mg (Celecoxib Exposure) | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.10 units on a scale | Standard Deviation 2.64 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.47 units on a scale | Standard Deviation 2.14 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.08 units on a scale | Standard Deviation 2.59 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.42 units on a scale | Standard Deviation 2.7 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.28 units on a scale | Standard Deviation 2.51 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.35 units on a scale | Standard Deviation 2.62 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.15 units on a scale | Standard Deviation 2.48 |
| Tanezumab 5 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.41 units on a scale | Standard Deviation 2.31 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.33 units on a scale | Standard Deviation 2.01 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -2.39 units on a scale | Standard Deviation 2.59 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -2.25 units on a scale | Standard Deviation 2.43 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -1.11 units on a scale | Standard Deviation 2.44 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -2.60 units on a scale | Standard Deviation 2.51 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -2.62 units on a scale | Standard Deviation 2.64 |
| Tanezumab 10 mg + Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -2.72 units on a scale | Standard Deviation 2.54 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 16 | -1.34 units on a scale | Standard Deviation 2.13 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 24 | -1.38 units on a scale | Standard Deviation 2.18 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 2 | -0.82 units on a scale | Standard Deviation 2.04 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 12 | -1.23 units on a scale | Standard Deviation 2.16 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 8 | -1.13 units on a scale | Standard Deviation 2.16 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Baseline | 6.39 units on a scale | Standard Deviation 1.89 |
| Celecoxib 100 mg | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF) | Change at Week 4 | -1.00 units on a scale | Standard Deviation 2.18 |
Secondary
Number of Participants Who Had Discontinued Study Due to Lack of Efficacy
Time frame: Baseline up to Week 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 23 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 23 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 22 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 15 Participants |
| Naproxen 500 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 40 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 19 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 21 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 15 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 18 Participants |
| Celecoxib 100 mg | Number of Participants Who Had Discontinued Study Due to Lack of Efficacy | 38 Participants |
Secondary
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 127 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 29 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 78 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 198 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 17 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 4 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 179 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 103 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 53 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 148 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 43 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 162 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 29 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 135 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 18 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 50 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 11 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 184 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 94 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 201 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 75 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 117 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 118 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 61 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 12 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 183 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 199 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 19 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 158 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 139 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 31 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 42 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 96 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 174 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 194 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 71 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 104 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 10 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 24 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 82 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 45 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 132 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 203 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 154 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 39 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 102 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 172 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 56 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 130 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 22 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 7 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 153 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 81 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 3 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 14 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 89 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 177 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 162 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 142 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 122 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 108 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 70 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 51 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 31 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 19 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 5 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 15 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 89 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 68 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 150 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 114 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 124 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 167 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 182 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 8 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 34 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 46 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 36 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 20 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 151 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 176 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 56 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 193 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 96 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 135 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 72 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 7 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 115 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 184 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 79 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 123 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 63 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 138 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 162 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 50 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 11 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 32 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 194 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 108 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=90% | 7 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=20% | 124 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >0% | 170 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=60% | 44 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=70% | 25 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=30% | 100 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=50% | 62 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | 100% | 5 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=10% | 150 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=80% | 13 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF) | >=40% | 81 Participants |
Secondary
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of \>0% to \>=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
Time frame: Baseline, Week 16
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 140 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 31 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 86 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 228 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 17 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 4 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 203 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 114 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 58 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 167 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 46 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 183 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 30 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 150 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 19 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 52 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 12 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 210 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 103 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 234 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 79 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 129 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 132 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 68 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 14 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 215 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 233 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 21 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 181 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 159 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 36 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 47 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 105 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 201 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 229 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 78 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 119 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 12 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 26 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 92 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 48 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 150 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 245 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 176 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 43 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 112 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 201 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 61 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 144 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 24 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 7 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 175 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 88 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 3 Participants |
| Naproxen 500 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 16 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 97 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 197 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 179 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 157 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 133 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 117 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 77 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 53 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 32 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 20 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 5 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 17 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 93 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 72 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 167 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 120 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 137 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 184 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 202 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 8 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 38 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 50 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 37 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 20 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 163 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 188 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 58 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 208 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 100 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 145 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 75 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 7 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 120 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 197 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 80 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 127 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 63 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 145 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 173 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 50 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 11 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 32 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 208 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 111 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=90% | 7 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=20% | 134 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >0% | 188 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=60% | 45 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=70% | 25 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=30% | 106 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=50% | 65 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | 100% | 5 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=10% | 162 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=80% | 13 Participants |
| Celecoxib 100 mg | Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | >=40% | 84 Participants |
Secondary
Number of Participants With Intravenous (IV) Doses of Study Medication
Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.
Time frame: Baseline up to Week 48
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 45 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 27 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 41 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 19 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 32 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 71 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 50 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 70 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 28 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 51 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 41 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 18 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 36 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 44 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 51 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 66 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 17 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 46 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 45 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 36 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 19 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 16 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 44 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 47 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 31 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 55 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 74 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 21 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 44 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 35 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 30 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 21 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 74 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 33 Participants |
| Naproxen 500 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 46 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 15 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 82 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 39 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 41 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 25 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 41 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 13 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 16 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 35 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 78 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 19 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 34 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 30 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 42 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 12 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 22 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 43 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 44 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 33 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 84 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 18 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 38 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 21 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 41 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 72 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 22 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 48 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 12 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 2 | 24 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 7 | 44 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 4 | 37 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 1 | 22 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 6 | 44 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 3 | 12 Participants |
| Celecoxib 100 mg | Number of Participants With Intravenous (IV) Doses of Study Medication | Number of IV Doses: 5 | 73 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Time frame: Baseline up to Week 64
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 203 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 22 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 211 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 23 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 205 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 28 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 207 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 30 Participants |
| Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 22 Participants |
| Naproxen 500 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 192 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 22 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 202 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 23 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 188 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 185 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 26 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 193 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 34 Participants |
| Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 172 Participants |
| Celecoxib 100 mg | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 21 Participants |
Secondary
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
Time frame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 65.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 71.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 69.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 68.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 63.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 60.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 66.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 68.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 65.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 66.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 64.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 63.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 59.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 69.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 61.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 66.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 64.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 66.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 62.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 64.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 54.7 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 56.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 55.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 55.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 60.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 63.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 60.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 61.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 63.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 65.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 60.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 64.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 58.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 63.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 64.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 57.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 67.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 64.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 63.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 60.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 69.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 63.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 66.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 71.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 75.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 69.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 72.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 70.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 63.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 71.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 71.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 65.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 67.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 69.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 71.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 69.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 71.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 70.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 71.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 69.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 67.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 63.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 64.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 62.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 64.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 61.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 67.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 64.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 70.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 67.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 63.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 60.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 63.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 62.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 66.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 59.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 62.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 60.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 60.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 62.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 59.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 65.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 64.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 59.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 65.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 61.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 66.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 68.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 65.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 62.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 17-24 | 69.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 1-2 | 63.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 3-4 | 66.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 25-32 | 74.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 33-40 | 71.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 9-12 | 68.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 41-48 | 72.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 49-56 | 71.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 5-8 | 67.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF) | Weeks 13-16 | 70.7 percentage of participants |
Secondary
Percentage of Participants Who Used Rescue Medication: Observed Data
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
Time frame: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 68.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 69.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 63.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 66.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 67.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 64.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 67.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 60.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 66.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 66.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 65.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 61.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 62.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 64.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 69.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 67.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 67.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 63.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 59.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 71.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 56.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 57.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 55.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 55.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 62.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 59.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 59.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 62.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 58.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 64.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 61.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 57.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 57.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 59.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 62.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 66.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 74.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 60.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 60.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 61.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 68.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 61.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 62.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 64.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 68.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 76.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 69.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 73.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 66.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 78.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 62.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 63.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 64.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 69.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 68.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 66.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 64.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 75.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 68.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 67.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 64.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 71.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 65.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 61.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 64.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 70.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 64.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 74.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 70.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 61.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 63.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 60.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 59.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 62.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 63.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 72.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 64.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 59.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 60.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 62.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 66.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 62.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 57.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 79.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 52.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 66.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 63.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 57.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 61.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 60.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 33-40 | 61.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 13-16 | 68.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 25-32 | 71.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 5-8 | 66.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 9-12 | 65.9 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 41-48 | 65.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 1-2 | 63.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 17-24 | 66.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 49-56 | 77.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants Who Used Rescue Medication: Observed Data | Weeks 3-4 | 66.0 percentage of participants |
Secondary
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30 percent, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported.
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 5.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 4.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 41.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 49.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 16.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 6.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 16.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 49.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 14.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 49.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 48.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 29.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 24.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 18.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 11.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 49.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 46.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 6.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 30.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 2.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 31.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 5.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 5.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 17.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 5.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 16.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 15.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 16.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 17.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 32.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 30.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 47.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 28.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 30.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 30.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 34.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 35.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 31.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 50.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 17.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 17.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 7.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 26.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 52.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 6.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 8.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 16.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 50.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 4.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 46.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 16.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 35.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 30.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 51.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 6.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 18.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 3.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 12.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 53.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 5.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 15.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 36.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 28.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 50.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 18.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 35.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 5.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 16.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 30.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 51.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 52.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 5.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 17.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 33.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 37.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 28.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 20.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 59.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 51.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 51.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 2.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 34.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 53.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 19.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 5.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 4.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 4.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 19.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 15.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 30.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 35.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 6.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 16.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 27.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 6.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 30.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 15.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 15.7 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 53.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 31.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 54.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 4.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 51.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 16.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 16.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 33.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 53.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 6.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 56.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 33.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 33.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 24.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 16.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 7.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 9.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 55.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 40.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 24.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 56.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 42.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 22.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 8.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 52.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 38.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 5.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 51.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 36.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 18.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 6.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 52.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 36.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 17.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 17.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 4.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 55.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 38.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 22.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 8.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 60.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 43.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 26.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 10.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 61.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 41.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 27.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 25.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 22.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 21.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 20.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 3.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 42.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 9.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 5.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 12.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 25.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 44.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 3.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 27.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 2.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 8.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 22.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 8.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 40.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 5.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 4.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 21.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 23.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 42.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 36.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 2.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 11.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 12.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 8.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 30.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 13.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 3.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 39.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 17.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 31.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 2.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 40.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 9.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 2.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 6.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 41.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 14.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 29.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 34.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 30.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 23.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 5.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 5.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 28.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 20.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 52.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 46.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 14.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 28.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 49.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 12.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 2.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 5.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 49.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 17.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 52.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 46.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 16.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 5.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 34.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 20.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 14.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 4.7 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 7.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 7.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 48.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 35.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 16.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 7.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 36.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 49.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 38.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 53.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 31.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 20.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 51.6 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 5.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 49.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 31.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 18.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 20.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 5.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 46.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 35.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 28.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 16.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 53.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 4.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 26.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 11.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 6.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 3.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 36.6 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 48.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 30.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 41.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 17.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 22.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 57.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 37.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 6.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 20.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 19.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 8.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 13.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 21.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 9.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 50.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 36.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 8.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 47.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 37.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 22.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 19.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 52.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 52.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 39.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 33.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 34.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 10.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 20.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 19.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 22.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 39.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 57.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 7.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 33.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 56.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 39.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 50.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 7.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 21.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 17.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 21.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 18.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 30.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 52.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 30.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 7.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 31.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 16.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 20.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 23.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 3.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 57.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 22.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 24.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 39.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 37.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 12.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 60.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 8.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 57.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 53.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 26.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 42.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 51.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 8.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 11.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 52.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 24.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 43.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 21.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 5.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 24.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 18.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 37.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 39.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 56.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 50.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 9.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 9.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 11.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 37.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 53.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 43.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 20.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 32.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 12.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=50% Reduction | 27.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=30% Reduction | 41.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=70% Reduction | 9.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=90% Reduction | 1.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=70% Reduction | 7.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=70% Reduction | 12.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=50% Reduction | 25.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=70% Reduction | 11.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=90% Reduction | 2.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=90% Reduction | 2.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=50% Reduction | 18.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=70% Reduction | 11.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=90% Reduction | 2.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=50% Reduction | 28.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=30% Reduction | 24.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=70% Reduction | 11.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=70% Reduction | 9.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=50% Reduction | 27.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=30% Reduction | 31.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=90% Reduction | 2.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=30% Reduction | 31.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=50% Reduction | 11.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=30% Reduction | 37.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 2: >=70% Reduction | 5.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=90% Reduction | 2.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 4: >=90% Reduction | 1.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=30% Reduction | 45.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=70% Reduction | 12.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=30% Reduction | 42.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=70% Reduction | 9.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 16: >=30% Reduction | 41.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=30% Reduction | 41.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 12: >=50% Reduction | 22.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 32: >=30% Reduction | 43.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 8: >=50% Reduction | 18.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=50% Reduction | 27.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 56: >=90% Reduction | 2.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 48: >=90% Reduction | 2.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 24: >=90% Reduction | 3.9 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF) | Week 40: >=50% Reduction | 29.0 percentage of participants |
Secondary
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of \>=30%, \>=50%, \>=70%, or \>=90% in the WOMAC pain subscale scores from Baseline were reported.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 27.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 15.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 17.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 43.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 6.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 6.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 5.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 40.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 4.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 13.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 2.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 30.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 11.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 14.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 28.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 45.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 14.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 24.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 27.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 40.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 44.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 27.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 3.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 33.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 47.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 16.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 26.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 7.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 31.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 17.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 44.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 8.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 17.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 45.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 32.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 30.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 16.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 12.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 32.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 3.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 17.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 46.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 34.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 18.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 52.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 6.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 53.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 6.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 27.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 18.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 35.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 6.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 15.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 16.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 32.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 49.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 2.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 49.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 6.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 6.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 44.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 6.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 20.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 15.0 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 29.6 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 28.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 4.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 24.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 35.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 47.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 34.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 54.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 9.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 54.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 46.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 24.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 7.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 7.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 32.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 21.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 23.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 49.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 21.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 16.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 39.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 6.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 8.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 36.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 17.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 12.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 36.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 22.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 5.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 29.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 19.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 6.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 2.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 29.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 16.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 8.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 2.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 34.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 19.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 7.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 2.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 19.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 7.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 2.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 36.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 21.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 11.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 3.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 15.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 48.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 35.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 13.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 42.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 5.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 33.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 48.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 13.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 39.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 12.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 20.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 27.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 4.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 22.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 30.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 28.0 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 44.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 2.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 7.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 4.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 29.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 18.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 7.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 35.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 16.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 6.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 52.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 33.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 3.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 6.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 22.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 46.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 45.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 11.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 35.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 48.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 13.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 26.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 5.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 18.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 41.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 7.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 6.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 51.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 53.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 16.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 37.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 30.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 20.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 49.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 52.9 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 37.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 22.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 17.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 7.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 47.1 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 30.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 7.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 35.3 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 33.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 21.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 18.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 18.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 23.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 54.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 12.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 32.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 41.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 53.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 26.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 7.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 58.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 19.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 23.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 55.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 41.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 8.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 10.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 23.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 11.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 5.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 36.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 42.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 3.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 50.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 24.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=70% Reduction | 5.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=90% Reduction | 1.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=70% Reduction | 9.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=70% Reduction | 9.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=50% Reduction | 24.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=90% Reduction | 2.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=50% Reduction | 25.9 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=90% Reduction | 2.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=50% Reduction | 11.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=50% Reduction | 21.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=90% Reduction | 2.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=30% Reduction | 24.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=30% Reduction | 39.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=50% Reduction | 18.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 12: >=30% Reduction | 36.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=30% Reduction | 30.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 16: >=70% Reduction | 9.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=30% Reduction | 41.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=90% Reduction | 3.9 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 2: >=90% Reduction | 1.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 24: >=70% Reduction | 11.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=30% Reduction | 31.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 8: >=50% Reduction | 18.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF | Week 4: >=70% Reduction | 7.1 percentage of participants |
Secondary
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported.
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 16.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 14.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 14.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 14.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 10.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 9.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 14.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 20.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 16.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 15.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 22.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 20.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 10.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 15.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 14.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 16.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 20.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 17.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 22.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 18.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 17.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 8.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 19.3 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 20.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 18.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 15.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 16.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 13.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 12.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 13.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 16.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 21.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 20.7 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 10.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 16.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 24.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 15.8 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 18.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 23.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 27.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 12.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 10.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 13.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 14.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 16.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 9.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 13.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 15.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 6.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 14.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 19.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 19.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 21.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 20.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 14.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 16.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 18.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 11.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 17.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 17.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 16.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 20.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 15.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 18.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 18.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 18.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 15.0 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 9.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 11.8 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 14.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 18.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 21.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 19.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 19.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 18.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 18.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 18.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 20.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 12.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 20.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 19.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 17.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 18.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 23.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 20.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 14.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 20.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 17.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 22.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 5.9 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 24 | 15.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 2 | 6.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 4 | 11.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 32 | 15.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 40 | 15.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 12 | 13.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 48 | 14.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 56 | 15.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 8 | 13.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF) | Week 16 | 14.6 percentage of participants |
Secondary
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of \>=2 points on scale were reported.
Time frame: Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 9.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 14.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 17.6 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 14.8 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 10.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 15.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 13.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 19.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 18.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 10.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 17.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 18.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 8.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 12.1 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 17.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 16.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 18.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 18.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 25.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 19.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 18.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 10.9 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 15.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 22.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 10.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 6.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 9.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 12.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 10.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 14.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 15.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 19.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 13.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 11.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 18.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 17.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 16.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 17.7 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 18.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 15.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 9.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 12.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 20.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 18.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 19.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 20.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 12.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 18.8 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 5.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 17.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 20.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 14.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 22.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 18.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 12 | 12.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 16 | 13.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 8 | 11.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 24 | 13.0 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 2 | 6.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF) | Week 4 | 10.6 percentage of participants |
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition).
Time frame: Weeks 2, 4, 8, 12, 16, and 24
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 40.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 49.5 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 48.1 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 52.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 53.0 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 54.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 57.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 53.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 58.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 35.5 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 56.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 50.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 43.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 51.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 60.7 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 56.8 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 61.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 60.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 61.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 58.3 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 51.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 36.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 54.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 60.1 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 39.7 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 31.8 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 39.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 42.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 45.2 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 41.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 53.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 51.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 49.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 39.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 55.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 56.6 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 57.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 59.1 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 55.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 55.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 33.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 53.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 62.1 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 54.7 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 59.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 59.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 39.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 57.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 33.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 65.0 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 59.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 57.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 65.7 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 63.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 12 | 45.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 16 | 47.3 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 8 | 42.6 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 24 | 49.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 2 | 32.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF) | Week 4 | 41.0 percentage of participants |
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was \>=50 percent and \>=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was \>=20 percent and \>=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[worst possible pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition).
Time frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 53.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 58.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 40.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 60.7 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 57.2 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 60.4 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 57.9 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 59.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 53.3 percentage of participants |
| Tanezumab 5 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 60.4 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 62.2 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 61.8 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 54.9 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 57.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 56.3 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 57.6 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 59.0 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 60.1 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 59.7 percentage of participants |
| Tanezumab 10 mg (Naproxen Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 35.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 62.5 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 43.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 65.7 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 68.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 65.7 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 63.2 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 61.4 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 58.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 57.9 percentage of participants |
| Tanezumab 5 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 57.5 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 57.6 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 69.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 68.4 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 64.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 63.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 36.1 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 58.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 58.0 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 62.2 percentage of participants |
| Tanezumab 10 mg + Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 59.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 41.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 48.4 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 50.9 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 49.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 52.3 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 49.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 46.6 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 50.5 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 41.0 percentage of participants |
| Naproxen 500 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 31.8 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 53.1 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 58.2 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 39.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 56.3 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 60.5 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 60.9 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 58.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 57.4 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 56.6 percentage of participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 57.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 55.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 62.2 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 53.5 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 61.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 56.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 33.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 56.3 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 55.9 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 63.4 percentage of participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 65.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 62.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 65.6 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 64.1 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 57.8 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 57.0 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 60.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 39.5 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 57.4 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 58.2 percentage of participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 61.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 62.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 33.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 60.6 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 59.4 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 58.3 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 64.2 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 66.5 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 57.9 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 68.1 percentage of participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 66.5 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 40 | 49.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 16 | 51.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 32 | 53.1 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 56 | 49.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 8 | 43.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 12 | 47.7 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 4 | 41.8 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 48 | 49.2 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 2 | 32.4 percentage of participants |
| Celecoxib 100 mg | Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF) | Week 24 | 55.1 percentage of participants |
Secondary
Plasma Trough (Pre-dose) Concentration of Tanezumab
Time frame: Predose on Day 1, Weeks 16, 24, 40, and 56
Population: Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure and Number analyzed' signifies participants evaluable at specified time points. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 24 | 250.813 nanogram/milliliter | Standard Deviation 375.396 |
| Tanezumab 5 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Day 1 | 48.4570 nanogram/milliliter | Standard Deviation 241.4173 |
| Tanezumab 5 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 40 | 231.840 nanogram/milliliter | Standard Deviation 211.392 |
| Tanezumab 5 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 16 | 222.779 nanogram/milliliter | Standard Deviation 228.0336 |
| Tanezumab 5 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 56 | 168.673 nanogram/milliliter | Standard Deviation 307.174 |
| Tanezumab 10 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 24 | 545.672 nanogram/milliliter | Standard Deviation 375.396 |
| Tanezumab 10 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 16 | 556.854 nanogram/milliliter | Standard Deviation 599.8115 |
| Tanezumab 10 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 40 | 523.214 nanogram/milliliter | Standard Deviation 365.6468 |
| Tanezumab 10 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Day 1 | 164.068 nanogram/milliliter | Standard Deviation 1045.628 |
| Tanezumab 10 mg (Naproxen Exposure) | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 56 | 385.733 nanogram/milliliter | Standard Deviation 456.5163 |
| Tanezumab 5 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 56 | 138.159 nanogram/milliliter | Standard Deviation 253.3517 |
| Tanezumab 5 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Day 1 | 102.398 nanogram/milliliter | Standard Deviation 543.2856 |
| Tanezumab 5 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 16 | 255.246 nanogram/milliliter | Standard Deviation 400.3175 |
| Tanezumab 5 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 24 | 271.632 nanogram/milliliter | Standard Deviation 368.0965 |
| Tanezumab 5 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 40 | 263.049 nanogram/milliliter | Standard Deviation 289.5641 |
| Tanezumab 10 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 56 | 377.231 nanogram/milliliter | Standard Deviation 422.0123 |
| Tanezumab 10 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 40 | 527.108 nanogram/milliliter | Standard Deviation 442.1378 |
| Tanezumab 10 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 16 | 723.316 nanogram/milliliter | Standard Deviation 2791.08 |
| Tanezumab 10 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Day 1 | 96.4720 nanogram/milliliter | Standard Deviation 481.0747 |
| Tanezumab 10 mg + Naproxen 500 mg | Plasma Trough (Pre-dose) Concentration of Tanezumab | Week 24 | 538.756 nanogram/milliliter | Standard Deviation 481.1859 |
Secondary
Time to Discontinuation Due to Lack of Efficacy
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
Time frame: Baseline up to Week 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Time to Discontinuation Due to Lack of Efficacy | 319.87 days | Standard Error 3.74 |
| Tanezumab 10 mg (Naproxen Exposure) | Time to Discontinuation Due to Lack of Efficacy | 331.69 days | Standard Error 3.65 |
| Tanezumab 5 mg + Naproxen 500 mg | Time to Discontinuation Due to Lack of Efficacy | 394.80 days | Standard Error 5.08 |
| Tanezumab 10 mg + Naproxen 500 mg | Time to Discontinuation Due to Lack of Efficacy | 271.89 days | Standard Error 2.66 |
| Naproxen 500 mg | Time to Discontinuation Due to Lack of Efficacy | 306.11 days | Standard Error 4.94 |
| Tanezumab 5 mg (Celecoxib Exposure) | Time to Discontinuation Due to Lack of Efficacy | 329.79 days | Standard Error 3.68 |
| Tanezumab 10 mg (Celecoxib Exposure) | Time to Discontinuation Due to Lack of Efficacy | 314.16 days | Standard Error 4.15 |
| Tanezumab 5 mg + Celecoxib 100 mg | Time to Discontinuation Due to Lack of Efficacy | 334.84 days | Standard Error 3.08 |
| Tanezumab 10 mg + Celecoxib 100 mg | Time to Discontinuation Due to Lack of Efficacy | 324.25 days | Standard Error 3.32 |
| Celecoxib 100 mg | Time to Discontinuation Due to Lack of Efficacy | 303.08 days | Standard Error 5.1 |
Other Pre-specified
Number of Participants With Anti-Drug Antibody (ADA) Response
Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level \>=4.32 for tanezumab were considered ADA positive.
Time frame: Baseline, Weeks 16, 40, 24, and 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 40 | 2 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 16 | 5 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 56 | 3 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 24 | 4 Participants |
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Baseline | 3 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 24 | 2 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 40 | 2 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 56 | 2 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 16 | 3 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Anti-Drug Antibody (ADA) Response | Baseline | 2 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 24 | 1 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Baseline | 4 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 16 | 4 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 40 | 5 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 56 | 1 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 40 | 2 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 16 | 0 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Baseline | 2 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 24 | 1 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Anti-Drug Antibody (ADA) Response | Week 56 | 2 Participants |
Other Pre-specified
Number of Participants With Positive Urine or Serum Pregnancy Test
Female participants, who reported positive in urine or serum pregnancy test were reported.
Time frame: Baseline up to Week 56
Population: ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tanezumab 5 mg (Naproxen Exposure) | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 10 mg (Naproxen Exposure) | Number of Participants With Positive Urine or Serum Pregnancy Test | 1 Participants |
| Tanezumab 5 mg + Naproxen 500 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 10 mg + Naproxen 500 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Naproxen 500 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 5 mg (Celecoxib Exposure) | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 10 mg (Celecoxib Exposure) | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 5 mg + Celecoxib 100 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Tanezumab 10 mg + Celecoxib 100 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |
| Celecoxib 100 mg | Number of Participants With Positive Urine or Serum Pregnancy Test | 0 Participants |