Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
- Registration Number
- NCT00809354
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2720
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Placebo + NSAID NSAID Oral NSAID Tanezumab 5 mg tanezumab IV tanezumab 5 mg every 8 weeks (through Week 48) Tanezumab 5 mg + NSAID tanezumab IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks Tanezumab 10 mg + NSAID tanezumab IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks Tanezumab 10 mg tanezumab IV tanezumab 10 mg every 8 weeks (through Week 48) Tanezumab 5 mg + NSAID NSAID IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks Tanezumab 10 mg + NSAID NSAID IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16 Baseline, Week 16 WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16 Baseline, Week 16 WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16 Baseline, Week 16 Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
- Secondary Outcome Measures
Name Time Method 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.
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 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.
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: 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).
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 at 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.
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.
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 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 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 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 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 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 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.
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 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 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 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 Minimum Joint Space Width of the Index Hip at Week 56 Baseline, Week 56 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.
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: 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
Trial Locations
- Locations (323)
Perimeter Institute for Clinical Reseach, Inc.
🇺🇸Atlanta, Georgia, United States
Laureate Clinical Research Group
🇺🇸Atlanta, Georgia, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
Kiev City Clinical Hospital #3
🇺🇦Kiev, Ukraine
Pharmax Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Community Research Foundation
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Miracle Medical Center
🇺🇸Houston, Texas, United States
California Research Foundation
🇺🇸San Diego, California, United States
Doctor's Urgent Care Offices
🇺🇸Cincinnati, Ohio, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Alamo Clinical Research Consultants
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Radiant Research San Antonio
🇺🇸San Antonio, Texas, United States
SAM Clinical Research Center
🇺🇸San Antonio, Texas, United States
San Antonio Preventive & Diagnostic Medicine, PA
🇺🇸San Antonio, Texas, United States
Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
🇮🇳Secunderabad, Andhra Pradesh, India
St. Johns Medical College Hospital, Department of Orthopaedics
🇮🇳Bangalore, Karnataka, India
Asian Hospital and Medical Center
🇵ðŸ‡Muntinlupa, Philippines
Centro Integral de Reumatologia e Inmunologia CIREI
🇨🇴Bogota, Cundinamarca, Colombia
Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
🇲🇽Culiacan Sinaloa, Mexico
CSM Medical University, Department of Rheumatology
🇮🇳Lucknow, UP, India
Chong Hua Hospital, Medical Arts Center
🇵ðŸ‡Cebu City, Philippines
Chinese General Hospital and Medical Center, Out Patient Department
🇵ðŸ‡Manila, Philippines
Davao Doctors Hospital, Medical Tower
🇵ðŸ‡Davao City, Philippines
Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
🇵ðŸ‡Manila, Philippines
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
McBride Clinic, Inc
🇺🇸Oklahoma City, Oklahoma, United States
Hillcrest Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Bone and Joint Hospital at St. Anthony
🇺🇸Oklahoma City, Oklahoma, United States
Christine Codding, MD
🇺🇸Oklahoma City, Oklahoma, United States
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Mc Bride Clinic
🇺🇸Oklahoma City, Oklahoma, United States
Associated Orthopedics, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Radiant Research - Phoenix Southeast
🇺🇸Chandler, Arizona, United States
Westlake Medical Center
🇺🇸Westlake Village, California, United States
Colorado Arthritis Center, PC
🇺🇸Englewood, Colorado, United States
Joao MA Nascimento, MD
🇺🇸Bridgeport, Connecticut, United States
Eclipse Clinical Research
🇺🇸Green Valley, Arizona, United States
Midwest Internal Medicine, PLLC
🇺🇸Lake Havasu City, Arizona, United States
Triwest Research
🇺🇸La Mesa, California, United States
Orange County Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Saadat Ansari, MD Office
🇺🇸Huntsville, Alabama, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Nature Coast Clinical Research
🇺🇸Crystal River, Florida, United States
Clinical Physiology Associates, Clinical Study Center
🇺🇸Fort Myers, Florida, United States
Advances in Medicine
🇺🇸Rancho Mirage, California, United States
Prohealth Partners
🇺🇸Long Beach, California, United States
Desert Medical Group Inc., Desert Oasis Healthcare
🇺🇸Palm Springs, California, United States
Lakewood Orthopedic Medical & Surgical Group
🇺🇸Lakewood, California, United States
New England Research Associates, LLC
🇺🇸Trumbull, Connecticut, United States
Med Center
🇺🇸Carmichael, California, United States
Med Investigations, Inc.
🇺🇸Fair Oaks, California, United States
Apex Research Institute
🇺🇸Santa Ana, California, United States
Colorado Springs Family Practice
🇺🇸Colorado Springs, Colorado, United States
Surgery Center of Aventura
🇺🇸Aventura, Florida, United States
HeartCare
🇺🇸Bradenton, Florida, United States
Covance CRU, Inc.
🇺🇸Daytona Beach, Florida, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Integrated Clinical Trial Services, Inc
🇺🇸West Des Moines, Iowa, United States
Vince and Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Florida Arthritis
🇺🇸Lake Mary, Florida, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
The Bone and Joint Clinic
🇺🇸Baton Rouge, Louisiana, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Berkshire Rheumatology
🇺🇸Pittsfield, Massachusetts, United States
Arthritis & Osteoporosis Associates
🇺🇸Toms River, New Jersey, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
American Health Network of Indiana, LLC
🇺🇸Avon, Indiana, United States
Rheumatology and Internal Medicine Associates of West County, P.C.
🇺🇸Saint Louis, Missouri, United States
Mark Fisher, MD, FACRUC
🇺🇸Haddon Heights, New Jersey, United States
Arthritis Consultants Inc.
🇺🇸Saint Louis, Missouri, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Springfield Clinical Research Department
🇺🇸Springfield, Illinois, United States
Columbus Clinical Research, Inc.
🇺🇸Columbus, Ohio, United States
Arthritis & Osteoporosis Associates, P.A.
🇺🇸Freehold, New Jersey, United States
Rheumatology Associates of North Jersey
🇺🇸Teaneck, New Jersey, United States
Piedmont Rheumatology
🇺🇸Hickory, North Carolina, United States
Arthritis and Osteoporosis Associates of Brooklyn Heights
🇺🇸Brooklyn, New York, United States
Multicare Specialists
🇺🇸Madisonville, Kentucky, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
The Center for Rheumatology, LLP
🇺🇸Albany, New York, United States
A & A Pain Institute
🇺🇸Saint Louis, Missouri, United States
Center for Arthritis and Osteoporosis
🇺🇸Elizabethtown, Kentucky, United States
Anderson and Collins Clinical Research Inc.
🇺🇸Edison, New Jersey, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States
Medex Healthcare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
NYU Hospital for Joint Diseases
🇺🇸New York, New York, United States
Daystar Clinical Research, Inc.
🇺🇸Akron, Ohio, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Neurology Clinic of Central Texas
🇺🇸New Braunfels, Texas, United States
Arthritis, Rheumatic & Back Disease Associates
🇺🇸Voorhees, New Jersey, United States
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
New Jersey Physicians, LLC
🇺🇸Passaic, New Jersey, United States
The Carolina Center for Rheumatology and Arthritis Care, PA
🇺🇸Rock Hill, South Carolina, United States
Radiant Research Inc
🇺🇸Greer, South Carolina, United States
Elise Wiesner, MD
🇺🇸Norman, Oklahoma, United States
Clinical Trials Research Services, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
STAT Research, Inc.
🇺🇸Dayton, Ohio, United States
DM Clinical Research
🇺🇸Houston, Texas, United States
Southern Orthopaedic Sports Medicine
🇺🇸Columbia, South Carolina, United States
The Family Healthcare Center, PA
🇺🇸Clinton, South Carolina, United States
Clinical Trials of America, Inc
🇺🇸Hickory, North Carolina, United States
Regional Medical Clinical-Rheumatology
🇺🇸Rapid City, South Dakota, United States
Dayton Science Institute (DSI)
🇺🇸Dayton, Ohio, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Southwest Rheumatology and Research Group, LLC
🇺🇸Middleburg Heights, Ohio, United States
Blair Orthopedics Associates
🇺🇸Altoona, Pennsylvania, United States
Southwest Clinical Research Centers, LLC
🇺🇸Pearland, Texas, United States
Robert R. King, M.D.
🇺🇸Lubbock, Texas, United States
Southwest Rheumatology, PA
🇺🇸Mesquite, Texas, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
McBride Clinic
🇺🇸Norman, Oklahoma, United States
One Step Diagnostic
🇺🇸Houston, Texas, United States
Columbia Arthritis Center P.A.
🇺🇸Columbia, South Carolina, United States
LION Research
🇺🇸Norman, Oklahoma, United States
Ramesh C. Gupta, M.D.
🇺🇸Memphis, Tennessee, United States
Rheumatology Associates Inc
🇺🇸Tulsa, Oklahoma, United States
Gill Orthopedic Center
🇺🇸Lubbock, Texas, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Pearland Primary Care Associates
🇺🇸Pearland, Texas, United States
Abilene Arthritis Center
🇺🇸Abilene, Texas, United States
ChanRe Rheumatology & Immunology Center & Research
🇮🇳Bangalore, Karnataka, India
Innovative Clinical Trials
🇺🇸San Antonio, Texas, United States
Hospital Aranda de la Parra
🇲🇽Leon Gto, Mexico
Diaz Building
🇵ðŸ‡Cebu City, Philippines
Plano Primary Care Clinic
🇺🇸Plano, Texas, United States
KW Musculoskeletal Research Inc.
🇨🇦Kitchener, Ontario, Canada
Doris M. Rice, M.D., F.A.C.R.
🇺🇸Portsmouth, Virginia, United States
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Antioquia, Colombia
Riesgo de Fractura S.A.
🇨🇴Bogota-Cundinamarca, Colombia
PSG Institute of Medical Sciences and Research
🇮🇳Coimbatore, Tamilnadu, India
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
🇲🇽Coahuila, Mexico
Tacoma Center for Arthritis Research, PS
🇺🇸Tacoma, Washington, United States
Centre de Recherche Musculo-Squelettique
🇨🇦Trois-Rivieres, Quebec, Canada
Scott & White Healthcare
🇺🇸Temple, Texas, United States
Cebu Orthopedic Institute
🇵ðŸ‡Cebu City, Philippines
South Texas Radiology Imaging Center
🇺🇸San Antonio, Texas, United States
UMC Utrecht
🇳🇱Utrecht, Netherlands
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Sancheti Hospital
🇮🇳Pune, Maharashtra, India
Office of Diane Wilson
🇨🇦Lunenburg, Nova Scotia, Canada
Phelang Private Hospital Research Unit
🇿🇦Mamelodi East, Pretoria, South Africa
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
A. Briel
🇿🇦Durbanville, South Africa
Clinica Las Americas
🇨🇴Medellin, Colombia
M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
🇮🇳Bangalore, Karnataka, India
KMC Hospital, Department of Orthopaedics
🇮🇳Mangalore, Karnataka, India
UMC St. Radboud
🇳🇱Nijmegen, Netherlands
Polyclinique St. Eustache
🇨🇦St. Eustache, Quebec, Canada
State Healthcare Institution Moscow City Clinical Hospital #4
🇷🇺Moscow, Russian Federation
URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
🇲🇽Guadalajara, Jalisco, Mexico
Reumatologya S.A.
🇨🇴Medellin, Colombia
Davao Doctors Hospital
🇵ðŸ‡Davao City, Philippines
SKDS Research Inc.
🇨🇦Newmarket, Ontario, Canada
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
State Healthcare Institution: Moscow City Clinical Hospital #7
🇷🇺Moscow, Russian Federation
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Optimum Clinical Research, Inc.
🇺🇸Salt Lake City, Utah, United States
Radiant Research, Inc.
🇺🇸Salt Lake City, Utah, United States
State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
🇺🇦Kiev, Ukraine
Vincent Pallotti Hospital
🇿🇦Cape Town, South Africa
Complejo Hospitalario Universitario de A Coruna
🇪🇸A Coruna, Spain
TREAD Research
🇿🇦Parrowvalley, South Africa
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
🇪🇸Barcelona, Spain
Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
🇪🇸Sabadell, Barcelona, Spain
Worthwhile Clinical Trials
🇿🇦Benoni, South Africa
Hospital de Cruces, Servicio de Reumatologia
🇪🇸Barakaldo (Vizcaya), Spain
Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
🇷🇺Saint-Petersburg, Russian Federation
Randles Road Medical Center
🇿🇦Durban, South Africa
City Clinical Hospital #5
🇺🇦Donetsk, Ukraine
State Institution "Institute of Gerontology AMS of Ukraine"
🇺🇦Kiev, Ukraine
136 Panorama Medical Center
🇿🇦Panorama, Cape Town, South Africa
Tiervlei Trial Center
🇿🇦Bellville, South Africa
Hospital Universitario La Paz, Servicio de Reumatologia
🇪🇸Madrid, Spain
V.K. Gusak Institute of Urgent and Recovery Surgery
🇺🇦Donetsk, Ukraine
Municipal institution :Zaporizhzhya Regional Clinical Hospital
🇺🇦Zaporizhzhya, Ukraine
Hospital Nuestra Senora de Valme, Servicio de Reumatologia
🇪🇸Sevilla, Spain
Rheumatology Associates, P.C.
🇺🇸Birmingham, Alabama, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Shades Mountain Imaging
🇺🇸Birmingham, Alabama, United States
The Arthritis Program Research Group
🇨🇦Newmarket, Ontario, Canada
Dr. Saeed Shaikh
🇨🇦St. Catharines, Ontario, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Groupe de Recherche en Rhumatologie et Maladies Osseuses
🇨🇦Quebec, Canada
Josha Research
🇿🇦Bloemfontein, South Africa
Clinical Research Unit
🇿🇦Pretoria, South Africa
Saint-Petersburg State Healthcare Institution "City Hospital #26"
🇷🇺Saint-Petersburg, Russian Federation
Institution Of Russian Academy of Medical Sciences
🇷🇺Moscow, Russian Federation
Westroads Medical Group
🇺🇸Omaha, Nebraska, United States
Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
🇪🇸Santiago De Compostela, A Coruna, Spain
Pivotal Research Centers
🇺🇸Midvale, Utah, United States
Soutwest Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Tampa Medical Group, PA
🇺🇸Tampa, Florida, United States
Hill Country Medical Associates
🇺🇸New Braunfels, Texas, United States
Alamo Clinical Research Associates
🇺🇸San Antonio, Texas, United States
Texas Arthritis Research Center, PA
🇺🇸San Antonio, Texas, United States
Elite Clinical Studies, LLC
🇺🇸Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Phoenix, Arizona, United States
Arizona Research Associates
🇺🇸Tucson, Arizona, United States
Quality of Life Medical and Research Center
🇺🇸Tucson, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Paradise Valley, Arizona, United States
Deerbrook Medical Associates
🇺🇸Vernon Hills, Illinois, United States
Peak Health Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Premier Clinical Research LLC.
🇺🇸Lakewood, California, United States
Rheumatology Associates of North Alabama, PC
🇺🇸Huntsville, Alabama, United States
Little Rock Diagnostic Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Office of Vaughn H. Mancha, Jr., MD
🇺🇸Montgomery, Alabama, United States
Dedicated Clinical Research
🇺🇸Goodyear, Arizona, United States
Tucson Orthopaedic Institute
🇺🇸Tucson, Arizona, United States
Cochise Clinical Research
🇺🇸Sierra Vista, Arizona, United States
Premiere Phamaceutical Research, LLC
🇺🇸Tempe, Arizona, United States
eStudySite
🇺🇸San Jose, California, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Trinity Clinical Trials
🇺🇸Santa Ana, California, United States
Little Rock Family Practice Clinic
🇺🇸Little Rock, Arkansas, United States
San Diego Arthritis Medical Clinic
🇺🇸San Diego, California, United States
St. Joseph Medical Associates
🇺🇸Stockton, California, United States
International Physicans Research
🇺🇸Aventura, Florida, United States
Rheumatology Consultants of Delaware/Delaware Arthritis
🇺🇸Lewes, Delaware, United States
Homestead Clinical Research Group, P.A.
🇺🇸Cutler Bay, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Robert W. Levin MD
🇺🇸Dunedin, Florida, United States
Jeffrey Alper MD Research
🇺🇸Naples, Florida, United States
Internal Medicine Associates
🇺🇸Fargo, North Dakota, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Arthritis Research of Florida, Inc.
🇺🇸Palm Harbor, Florida, United States
American Family Medicine
🇺🇸Ocala, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States
University Clinical Research
🇺🇸Pembroke Pines, Florida, United States
Pembroke Clinical Trials
🇺🇸Pemkbroke Pines, Florida, United States
Advent Clinical Research Center Inc
🇺🇸Pinellas Park, Florida, United States
Berma Research Group
🇺🇸Plantation, Florida, United States
Advent Clinical Research Centers
🇺🇸Pinellas Park, Florida, United States
Lovelace Scientific Resources
🇺🇸Sarasota, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
HeartCare Research
🇺🇸Sarasota, Florida, United States
Kennedy-White Orthopaedic Center
🇺🇸Sarasota, Florida, United States
Dale G. Bramlet, MD, P.L.
🇺🇸Saint Petersburg, Florida, United States
Sarasota Center for Clinical Research
🇺🇸Sarasota, Florida, United States
The Arthritis Specialty Centre
🇺🇸Sarasota, Florida, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
ACCR/Internal Medicine
🇺🇸Roswell, Georgia, United States
Institute of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Idaho Arthritis & Osteoporosis Center, PC
🇺🇸Meridian, Idaho, United States
Saltzer Medical Group PA
🇺🇸Nampa, Idaho, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Rockford Orthopedic Associates
🇺🇸Rockford, Illinois, United States
Gulf Coast Research, LLC
🇺🇸Baton Rouge, Louisiana, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Beacon Clinical Research
🇺🇸Brockton, Massachusetts, United States
Rheumatology PC
🇺🇸Kalamazoo, Michigan, United States
Quest Research Institute
🇺🇸Bingham Farms, Michigan, United States
PCM Medical Services
🇺🇸Lansing, Michigan, United States
Justus J Fiechtner, MD
🇺🇸Lansing, Michigan, United States
Medical Research Associates
🇺🇸Traverse City, Michigan, United States
The Center for Clinical Trials
🇺🇸Biloxi, Mississippi, United States
Highland Community Hospital
🇺🇸Picayune, Mississippi, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
No. County Internal Medicine & Rheumatology
🇺🇸Florissant, Missouri, United States
Mississippi Medical Research
🇺🇸Picayune, Mississippi, United States
Prem C. Chatpar, MD, LLC
🇺🇸Plainview, New York, United States
Physicians East P. A.
🇺🇸Greenville, North Carolina, United States
Southgate Medical Group
🇺🇸West Seneca, New York, United States
Wake Internal Medicine Consultants Inc
🇺🇸Raleigh, North Carolina, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
David R. Mandel, MD, Inc
🇺🇸Mayfield, Ohio, United States
Integris Family Care of Norman
🇺🇸Norman, Oklahoma, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Aquilo Clinical Research
🇺🇸Yukon, Oklahoma, United States
Regional Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Arthritis Clinic
🇺🇸Jackson, Tennessee, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Philip Blum
🇺🇸Pasadena, Texas, United States
Advanced Family Medical Care
🇺🇸Plano, Texas, United States
The Rehab Group
🇺🇸San Antonio, Texas, United States
Sugar Land Med-Ped, PA
🇺🇸Sugar Land, Texas, United States
Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Gundersen Clinic Ltd.
🇺🇸Onalaska, Wisconsin, United States
MAC Research Inc.
🇨🇦Hamilton, Ontario, Canada
Dr. Anil Gupta
🇨🇦Toronto, Ontario, Canada
Clinique Medicale St-Louis
🇨🇦Quebec, Canada
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
READE
🇳🇱Amsterdam, Netherlands
Beneficencia Espanola de la Laguna
🇲🇽Torreon Coahuila, Mexico
Private Practice
🇿🇦Durban, South Africa
Saint Petersburg State Medical University named after Pavlov
🇷🇺Saint Petersburg, Russian Federation
Origin Clinical Research
🇿🇦Johannesburg, South Africa
Paarl Research Center
🇿🇦Paarl, South Africa
Clinresco Centres (Pty) Ltd
🇿🇦Kempton Park, South Africa
Hospital El Tomillar
🇪🇸Dos Hermanas, Sevilla, Spain
Clinica CIMA
🇪🇸Barcelona, Spain
Chernivtsi Regional Clinical Hospital
🇺🇦Chernivtsi, Ukraine
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Kiev City Oleksandrivska Clinical Hospital
🇺🇦Kiev, Ukraine
Joan Prouty Moore
🇺🇸Kansas City, Missouri, United States
Orthopaedic & Occupational Medicine
🇺🇸Kansas City, Missouri, United States
Dr. Paul K. Pickrell (Physician's Office)
🇺🇸Austin, Texas, United States
Mercy Imaging Center
🇺🇸Sacramento, California, United States
Arthritis Associates
🇺🇸Orlando, Florida, United States
Northern Clinical Research
🇺🇸Sacramento, California, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Dynamic Clinical Research, Inc.
🇺🇸Kansas City, Missouri, United States
National Clinical Research Richmond Inc.
🇺🇸Richmond, Virginia, United States
Pain Treatment Center of the Bluegrass
🇺🇸Lexington, Kentucky, United States
Pasadena Pharmacy
🇺🇸Lexington, Kentucky, United States
SPRI Bronx LLC
🇺🇸Bronx, New York, United States
PHP - Center for Clinical Research
🇺🇸Dayton, Ohio, United States
Hypothe Test, LLC
🇺🇸Roanoke, Virginia, United States
Radiant Research
🇺🇸Tucson, Arizona, United States