Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
- Conditions
- Chronic PainOsteoarthritis, HipOsteoarthritis, Knee
- Interventions
- Registration Number
- NCT02528188
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3021
- A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
- Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
- WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
- Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
- Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements
- Subjects exceeding protocol defined BMI or body weight limits
- History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
- Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
- A history of osteonecrosis or osteoporotic fracture
- History of significant trauma or surgery to a knee, hip or shoulder within the previous year
- Planned surgical procedure during the duration of the study
- Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
- Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
- Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
- Contraindications to magnetic resonance imaging
- History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated
- History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
- Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period
- History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol
- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities
- History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy
- History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
- History of known alcohol, analgesic or drug abuse within 2 years of Screening
- Previous exposure to exogenous NGF or to an anti-NGF antibody
- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein
- Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening
- Evidence of protocol defined orthostatic hypotension at Screening
- Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits
- Presence of drugs of abuse in screening urine toxicology panel
- Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
- Participation in other investigational drug studies within protocol defined time limits
- Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NSAID NSAID Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks Tanezumab 2.5 mg Tanezumab 2.5 mg Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks Tanezumab 5 mg Tanezumab 5 mg Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome Baseline up to Week 80 Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to \[\>=\] 2 millimeters \[mm\]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome Baseline up to Week 80 Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16 Baseline, Week 16 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16 Baseline, Week 16 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16 Baseline, Week 16 PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome Baseline up to Week 80 Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome Baseline up to Week 80 Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Percentage of Participants With Individual Adjudicated Joint Safety Outcome Baseline up to Week 80 Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW \>=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome Baseline up to Week 80 Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome Baseline up to Week 80 Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome Baseline up to Week 80 Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Baseline, Weeks 56 and 80 Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80 Baseline, Weeks 56 and 80 Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Weeks 56 and 80 Progression of OA according to Bland-Altman as defined by a decrease JSW \>=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 \[no radiographic features of OA\], 1 \[doubtful joint space narrowing (JSN) and possible osteophytic lipping\], 2 \[definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph\], 3 \[multiple osteophytes, definite JSN, sclerosis, possible bony deformity\], 4 \[large osteophytes, marked JSN, severe sclerosis and definite bony deformity\]. Higher grade indicating worse knee function.
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80 Weeks 56 and 80 Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW \>=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Pain Subscale at Week 64 Baseline, Week 64 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in WOMAC Physical Function Subscale at Week 64 Baseline, Week 64 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56 PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64 Baseline, Week 64 PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was \>=50 percent and \>= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and PGA of OA (score: 1 \[very good\] to 5 \[very poor\], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Percentage of participants with reduction in WOMAC pain intensity of \>= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56 Baseline, Weeks 16, 24 and 56 WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than \[\>\] 0% ; \>= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Percentage of participants with reduction in WOMAC physical function of \>=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56 Baseline, Weeks 16, 24 and 56 Percentage of participants with cumulative reduction (as percent) (\> 0 %; \>= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56 Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Change From Baseline in Average Pain Score in the Index Joint at Week 64 Baseline, Week 64 Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64 Baseline, Week 64 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64 Baseline, Week 64 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \[no pain\] to 10 \[extreme pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[no difficulty\] to 10 \[extreme difficulty\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[no stiffness\] to 10 \[extreme stiffness\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores 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, 16, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme 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 Week 64 Baseline, Week 64 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme 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, 16, 24, 32, 40, 48 and 56 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme 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 Week 64 Baseline, Week 64 WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56 Weeks 16, 24 and 56 WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64 Baseline, Week 64 WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain Baseline, Weeks 8, 16, 24, 40, 56 and 64 Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain Baseline, Weeks 8, 16, 24, 40, 56 and 64 Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain Baseline, Weeks 8, 16, 24, 40, 56 and 64 Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain Baseline, Weeks 8, 16, 24, 40, 56 and 64 Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain Baseline, Weeks 8, 16, 24, 40, 56 and 64 Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value Baseline, Weeks 8, 16, 24, 40, 56 and 64 EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (\<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses Weeks 16 and 56 TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied\]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale \[1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied\] and 1 question on 2 point scale \[0 =No, 1=Yes\]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling? Weeks 16 and 56 The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment? Weeks 16 and 56 The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain? Weeks 16 and 56 The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.
Number of Participants Who Withdrew Due to Lack of Efficacy Baseline up to Week 56 Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
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 first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Number of Participants Who Took Rescue Medication During Week 64 Week 64 In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56 In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Number of Days of Rescue Medication Used During Week 64 Week 64 In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16 Weeks 2, 4, 8 and 16 In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis Baseline, Weeks 64 and 80 Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis Baseline, Weeks 64 and 80 OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80 Baseline, Weeks 4, 8, 16, 24, 56 and 80 The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change \>0), No change and worsening (Change less than \[\<\] 0).
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56 Baseline, Weeks 16 and 56 Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56 Baseline, Weeks 16 and 56 An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56 Baseline, Weeks 16 and 56 An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {\<1500} counts moderate (1,500 - \<6500 counts), and vigorous (\>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56 Baseline, Weeks 16 and 56 An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - \<1,500 counts) moderate (1,500 - \<6,500 counts), and vigorous (\>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.
Change From Baseline in Average Daily Step Count at Weeks 16 and 56 Baseline, Weeks 16 and 56 Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Week 80 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Week 80 Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline Baseline up to Week 80 Primary Abnormality criteria: HGB, hematocrit, RBC count \<0.8\* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width \<0.9\*LLN, \>1.1\*upper limit of normal(ULN); platelets \<0.5\*LLN,\>1.75\*ULN; Leukocytes \<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Neutrophils \<0.8\*LLN, \>1.2\*ULN; Basophils,Eosinophils,Monocytes\>1.2\*ULN; Prothrombin time/Intl. normalized ratio\>1.1\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides \>1.3\*ULN; Urate\>1.2\*ULN; sodium\<0.95\*LLN,\>1.05\*ULN; potassium,chloride,calcium,magnesium,bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate\<0.8\*LLN, \>1.2\*ULN; glucose\<0.6\*LLN, \>1.5\*ULN; HGB A1C \>1.3\*ULN; creatine kinase\>2.0\*ULN, specific gravity\<1.003, \>1.030; pH\<4.5, \>8;Urine erythrocytes,Leukocytes\>=20.
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline Baseline up to Week 80 Primary Abnormality criteria: hemoglobin; hematocrit; RBC count \< 0.8\*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width \<0.9\*LLN, \>1.1\*ULN; platelets \<0.5\*LLN,\>1.75\*upper limit of normal (ULN); white blood cell count\<0.6\*LLN, \>1.5\*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes \<0.8\*LLN, \>1.2\*ULN; Basophils, Eosinophils, Monocytes \>1.2\*ULN; total bilirubin\>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase \>3.0\*ULN; total protein; albumin\<0.8\*LLN, \>1.2\*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides \>1.3\*ULN; Urate \>1.2\*ULN; sodium \<0.95\*LLN,\>1.05\*ULN; potassium, chloride, calcium, magnesium, bicarbonate \<0.9\*LLN, \>1.1\*ULN; phosphate \<0.8\*LLN, \>1.2\*ULN; glucose \<0.6\*LLN, \>1.5\*ULN; Hemoglobin A1C \>1.3\*ULN; creatine kinase \>2.0\*ULN; specific gravity\<1.003, \>1.030; Urine erythrocytes,Leukocytes\>=20; Hyaline Casts\>=1.
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Heart rate (pulse rate) was measured at sitting position.
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80 Baseline, Weeks 56 and 80 A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (\>) 30 millisecond (ms) or 60 ms; absolute value \> 450 ms, \>480 ms and \> 500 ms; 2) heart rate (HR) : absolute value \<=50 bpm and decrease from baseline \>=20 bpm; absolute value \>=120 beats per minute (bpm) and increase from baseline \>=20 bpm; 3) PR interval: absolute value \>=220 ms and increase from baseline \>=20 ms; 4) QRS interval: absolute value \>= 120 ms.
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80 Baseline, Weeks 56 and 80 Heart rate was measured at sitting position.
Number of Participants With Confirmed Orthostatic Hypotension Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP \<=150 mmHg (mean supine): Reduction in systolic BP\>=20 mmHg or reduction in diastolic BP\>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP \>150 mmHg (mean supine): Reduction in systolic BP\>=30 mmHg or reduction in diastolic BP\>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80 Baseline, Weeks 24, 56 and 80 The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80 NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Number of Participants With Anti-Tanezumab Antibodies Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80 Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Trial Locations
- Locations (485)
Chicago Clinical Research Institute Inc.
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center
🇺🇸Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
MUDr. STRANAI s.r.o.
🇸🇰Kosice, Slovakia
Reum.hapi s.r.o.
🇸🇰Nove Mesto nad Vahom, Slovakia
Changhua Christian Hospital Clinical Trial Pharmacy
🇨🇳Changhua, Taiwan
UMHAT Sveti Ivan Rilski- EAD
🇧🇬Sofia, Bulgaria
UMHAT "Sofiamed" OOD, Block 2
🇧🇬Sofia, Bulgaria
Medicinski centar Kuna&Peric
🇭🇷Zagreb, Croatia
National Hospital Organization Toyohashi Medical Center
🇯🇵Toyohashi, Aichi, Japan
Kanbara Clinic
🇯🇵Kitakyushu, Fukuoka, Japan
Himeno Hospital
🇯🇵Yamegun, Fukuoka, Japan
Ikeda Kinen Hospital
🇯🇵Sukagawa, Fukushima, Japan
Takahashi Orthopedics Clinic
🇯🇵Chitose, Hokkaido, Japan
Omuro Orthopedic Clinic
🇯🇵Himeji, Hyogo, Japan
Medical corporate corporation hoshikai Onishi medical clinic
🇯🇵Kako-gun, Hyogo, Japan
Saitama Municipal Hospital
🇯🇵Saitama, Japan
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Investigaciones en Reumatologia / Centro Medico Corpac S.A.
🇵🇪Lima, Peru
Philippine General Hospital
🇵🇭Manila, NCR, Philippines
Centro de Investigaciones Medicas-Hospital Maria Auxiliadora
🇵🇪Lima, Peru
Abigail R. Neiman, MD, PA
🇺🇸Houston, Texas, United States
Swedish Medical Center Investigational Drug Services Pharmacy
🇺🇸Seattle, Washington, United States
Seattle Rheumatology Associates
🇺🇸Seattle, Washington, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Clinical Research Consortium
🇺🇸Las Vegas, Nevada, United States
San Diego Imaging, Kearny Mesa
🇺🇸San Diego, California, United States
Sharp and Children's MRI Center, LLC
🇺🇸San Diego, California, United States
Office of Stephen H. Miller, MD
🇺🇸Las Vegas, Nevada, United States
G. Timothy Kelly, MD
🇺🇸Las Vegas, Nevada, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Pharmax Research Clinic, Inc.
🇺🇸Miami, Florida, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
M&M Medical Center, Inc.
🇺🇸Miami, Florida, United States
Quality Research & Medical Center LLC
🇺🇸Miami, Florida, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Panacea Clinical Research
🇺🇸San Antonio, Texas, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Accurate Clinical Research Inc.
🇺🇸San Antonio, Texas, United States
Victorium Clinical Research
🇺🇸San Antonio, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
South Texas Radiology Imaging Centers
🇺🇸San Antonio, Texas, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Rheumatology Associates of North Alabama, PC
🇺🇸Huntsville, Alabama, United States
Ferguson Family Medicine
🇺🇸Mesa, Arizona, United States
Noble Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Tucson Orthopaedic Institute - Research Center
🇺🇸Tucson, Arizona, United States
Med Investigations, Inc.
🇺🇸Fair Oaks, California, United States
Pleitez Medical Clinic
🇺🇸Covina, California, United States
San Diego Imaging Escondido
🇺🇸Escondido, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Allied Clinical Research
🇺🇸Gold River, California, United States
Collaborative Neuroscience Network, LLC.
🇺🇸Long Beach, California, United States
Marvel Clinical Research LLC
🇺🇸Huntington Beach, California, United States
BioSolutions Clinical Research Center
🇺🇸La Mesa, California, United States
HealthCare Partners Clinical Research, LLC.
🇺🇸Huntington Beach, California, United States
Center For United Research, Inc.
🇺🇸Lakewood, California, United States
Aeon Research, Inc.
🇺🇸Los Angeles, California, United States
InterMed Medical Group
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Probe Clinical Research Corporation
🇺🇸Riverside, California, United States
Renaissance Imaging Medical Associates, Inc
🇺🇸Van Nuys, California, United States
Advances in Medicine
🇺🇸Palm Desert, California, United States
Shariar Cohen, MD Corp.
🇺🇸Thousand Oaks, California, United States
Bayview Research Group
🇺🇸Valley Village, California, United States
Westlake Medical Research
🇺🇸Thousand Oaks, California, United States
Advanced Rx Clinical Research Group, Inc
🇺🇸Westminster, California, United States
Clinical Research Center of CT
🇺🇸Danbury, Connecticut, United States
AARDS Research, Inc.
🇺🇸Aventura, Florida, United States
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
RASF-Clinical Research, Inc
🇺🇸Boca Raton, Florida, United States
Orthopaedic Associates of West Florida
🇺🇸Clearwater, Florida, United States
S&W Clinical Research
🇺🇸Fort Lauderdale, Florida, United States
Midland Florida Clinical Research Center, LLC
🇺🇸DeLand, Florida, United States
Columbus Clinical Services LLC
🇺🇸Miami, Florida, United States
Pines Clinical Research Inc.
🇺🇸Hollywood, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Center for Arthritis and Rheumatic Diseases
🇺🇸Miami, Florida, United States
Larkin Imaging Center
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
American Family Medical
🇺🇸Ocala, Florida, United States
Journey Research, Inc.
🇺🇸Oldsmar, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Sacred Heart Orthopedics
🇺🇸Pensacola, Florida, United States
Orthopaedic Center of South Florida
🇺🇸Plantation, Florida, United States
St. Johns Center for Clinical Research
🇺🇸Ponte Vedra, Florida, United States
Gulfcoast Research Institute, LLC
🇺🇸Sarasota, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Precision Clinical Research, LLC.
🇺🇸Sunrise, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Compass Research North LLC
🇺🇸The Villages, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Arthritis Center of North Georgia
🇺🇸Gainesville, Georgia, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
Drug Studies America
🇺🇸Marietta, Georgia, United States
Medex Healthcare Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Affinity Clinical Research Institute
🇺🇸Oak Lawn, Illinois, United States
Southwest Center for Healthy Joints, S.C.
🇺🇸Oak Lawn, Illinois, United States
Methodist Research Administration Office
🇺🇸Peoria, Illinois, United States
UnityPoint Clinic Rheumatology
🇺🇸Peoria, Illinois, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
Baton Rouge General Medical Center-Clinical Trials Office
🇺🇸Baton Rouge, Louisiana, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Klein & Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
Great Lakes Research Group, Incorporated
🇺🇸Bay City, Michigan, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Beacon Clinical Research, LLC
🇺🇸Quincy, Massachusetts, United States
Orthopaedic Associates of Michigan, PC
🇺🇸Grand Rapids, Michigan, United States
Great Lakes Research Group
🇺🇸Pinconning, Michigan, United States
Michigan Orthopaedic Spine Surgeons
🇺🇸Rochester Hills, Michigan, United States
Medical Research Associates Inc.
🇺🇸Traverse City, Michigan, United States
ActivMed Practices & Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Ocean Rheumatology, PA
🇺🇸Toms River, New Jersey, United States
Lenox Hill Radiology
🇺🇸New York, New York, United States
Northstate Clinical Research, PLLC
🇺🇸Lenoir, North Carolina, United States
North Myrtle Beach Family Practice
🇺🇸North Myrtle Beach, South Carolina, United States
The Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
UMHAT Kaspela - EOOD Rheumatology Clinic
🇧🇬Plovdiv, Bulgaria
Ohimachi Orthopaedic Clinic
🇯🇵Shinagawa-ku, Tokyo, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Klaipeda University Hospital
🇱🇹Klaipeda, Lithuania
Auckland Bone Density Ltd
🇳🇿Auckland, New Zealand
The Radiology Group
🇳🇿Auckland, New Zealand
TRG Imaging Lincoln Road
🇳🇿Auckland, New Zealand
Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
🇵🇪Cayma, Arequipa, Peru
ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.
🇵🇪Lima, Peru
Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.
🇵🇪Trujillo, LA Libertad, Peru
Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.
🇵🇪Lima, Peru
Medinet LLC
🇷🇺Saint Petersburg, Russian Federation
Medical Technologies Ltd
🇷🇺Saint Petersburg, Russian Federation
Limited Liability Company "Medical Center "Reavita Med SPb"
🇷🇺Saint Petersburg, Russian Federation
Institute for treatment and rehabilitation "Niska Banja"
🇷🇸Niska Banja, Serbia
General hospital "Dr Laza K. Lazarevic" Sabac
🇷🇸Sabac, Serbia
Thermium s.r.o.
🇸🇰Piestany, Slovakia
China Medical University Hospital
🇨🇳Taichung, Taiwan
Oleksandrivska Clinical Hospital Of Kyiv
🇺🇦Kyiv, Ukraine
Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
🇺🇦Kharkiv, Ukraine
Kyiv City Clinical Hospital 3,Rheumatology Department
🇺🇦Kyiv, Ukraine
Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department
🇺🇦Lviv, Ukraine
Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,
🇺🇦Odesa, Ukraine
Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,
🇺🇦Vinnytsia, Ukraine
Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD
🇺🇦Vinnytsia, Ukraine
Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical
🇺🇦Vinnytsia, Ukraine
Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3
🇺🇦Vinnytsia, Ukraine
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Phoenix, Arizona, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
CMIP-Centro Mineiro de Pesquisa LTDA
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
RK Will Pty Ltd
🇦🇺Victoria Park, Western Australia, Australia
Mid-America Physiatrists, P.A.
🇺🇸Overland Park, Kansas, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Alabama Orthopaedic Surgeons
🇺🇸Birmingham, Alabama, United States
Mountain View Clinical Research, Inc
🇺🇸Denver, Colorado, United States
Arthritis & Osteoporosis Medical Center
🇺🇸La Palma, California, United States
The Catholic University of Korea Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Clinical Research Pharmacy, SMG SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Larry Watkins, MD
🇺🇸Little Rock, Arkansas, United States
Osteoporosis Medical Center
🇺🇸Beverly Hills, California, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
KLR Business Group, Inc., dba Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Med Center
🇺🇸Carmichael, California, United States
eStudySite
🇺🇸La Mesa, California, United States
Elite Clinical Trials
🇺🇸Wildomar, California, United States
New England Research Associates, LLC
🇺🇸Bridgeport, Connecticut, United States
Buhay & Maglunog MDS
🇺🇸West Covina, California, United States
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
River Birch Research Alliance, LLC
🇺🇸Blue Ridge, Georgia, United States
Injury Care Research, LLC
🇺🇸Boise, Idaho, United States
Institute Of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Idaho Sports Medicine Institute
🇺🇸Boise, Idaho, United States
Baton Rouge General Medical Center-Internal Medicine Clinic
🇺🇸Baton Rouge, Louisiana, United States
North Georgia Internal Medicine
🇺🇸Woodstock, Georgia, United States
Baton Rouge General Medical Center-Midcity
🇺🇸Baton Rouge, Louisiana, United States
Atlanta Orthopaedic Institute, LLC
🇺🇸Stockbridge, Georgia, United States
Phoenix Medical Research, Inc.
🇺🇸Prairie Village, Kansas, United States
Otrimed Corporation
🇺🇸Edgewood, Kentucky, United States
Arthritis Treatment Center
🇺🇸Frederick, Maryland, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
June D.O. PC
🇺🇸Lansing, Michigan, United States
Baton Rouge General Medical Center-Bluebonnet
🇺🇸Baton Rouge, Louisiana, United States
University of Missouri Health Care-Investigational Pharmacy
🇺🇸Columbia, Missouri, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Affiliated Clinical Research, Inc.
🇺🇸Las Vegas, Nevada, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
University of Missouri School of Medicine- Clinical Research Center
🇺🇸Columbia, Missouri, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
Advance Clinical Research, Inc.
🇺🇸Saint Louis, Missouri, United States
Landmark Internal Medicine
🇺🇸Southaven, Mississippi, United States
Office of Robert P. Kaplan, DO
🇺🇸Las Vegas, Nevada, United States
NYU Langone Ambulatory Care Brooklyn Heights
🇺🇸Brooklyn, New York, United States
Arthritis, Rheumatic and Back Disease Associates, PA
🇺🇸Voorhees, New Jersey, United States
Drug Trials Brooklyn
🇺🇸Brooklyn, New York, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Manhattan Medical Research Practice PLLC
🇺🇸New York, New York, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Upstate Clinical Research Associates, LLC
🇺🇸Williamsville, New York, United States
Lillestol Research, LLC
🇺🇸Fargo, North Dakota, United States
The Medical Research Network, LLC
🇺🇸New York, New York, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Main Street Physician's Care - Waterway
🇺🇸Little River, South Carolina, United States
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Plains Clinical Research Center, LLC
🇺🇸Fargo, North Dakota, United States
The Clinical Trial Center LLC
🇺🇸Jenkintown, Pennsylvania, United States
Main Street Physician's Care - Loris
🇺🇸Loris, South Carolina, United States
Optimus Clinical Research Pty Ltd
🇦🇺Kogarah, New South Wales, Australia
PMG Research, Inc. d/b/a PMG Research of Knoxville
🇺🇸Jefferson City, Tennessee, United States
Diagnostic Consultative Center "Sveti Georgi" EOOD
🇧🇬Plovdiv, Bulgaria
Capital Radiology-Malvern
🇦🇺Melbourne, Victoria, Australia
SKG Radiology Hollywood
🇦🇺Nedlands, Western Australia, Australia
Urgent Care MD's
🇺🇸Baytown, Texas, United States
"Medical Center- Dr. Hayvazov" EOOD
🇧🇬Sofia, Bulgaria
Centro Integral de Reumatologia Reumalab S.A.S.
🇨🇴Medellin, Antioquia, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS
🇨🇴Bogota, Bogota DC, Colombia
Clinical Trial Center Pharmacy
🇰🇷Seoul, Korea, Republic of
Oita University Hospital
🇯🇵Yufu, Oita, Japan
Sonodakai Joint Replacement Center Hospital
🇯🇵Adachi-ku, Tokyo, Japan
Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
Fujieda Municipal General Hospital
🇯🇵Fujieda, Shizuoka, Japan
Kuroda Orthopedic Hospital
🇯🇵Fukuoka, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima, Japan
Matsudo City General Hospital
🇯🇵Matsudo, Chiba, Japan
Obihiro Orthopaedic Hospital
🇯🇵Obihiro, Hokkaido, Japan
Mito Saiseikai General Hospital
🇯🇵Mito, Ibaraki, Japan
Rinku General Medical Center
🇯🇵Izumisano, Osaka, Japan
Shimane University Hospital
🇯🇵Izumo, Shimane, Japan
JA Shizuoka Kohseiren Enshu Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Japanese Red Cross Hamamatsu Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Jukoukai hospital
🇯🇵Koto-ku, Tokyo, Japan
State Budgetary Institution of Ryazan Region
🇷🇺Ryazan, Russian Federation
Genesis Research Services
🇦🇺Broadmeadow, New South Wales, Australia
SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"
🇷🇺Moscow, Russian Federation
Clinical Trial Pharmacy
🇰🇷Yangcheon-gu, Seoul, Korea, Republic of
Auckland Bone Density
🇳🇿Auckland, New Zealand
Lakeland Clinical Trials
🇳🇿Rotorua, BOP, New Zealand
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Department of Clinical Research Pharmacy, Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Saules seimos medicinos centras
🇱🇹Kaunas, Lithuania
PCET Research Center, LLC
🇺🇸Knoxville, Tennessee, United States
Funabashi Municipal Medical Center
🇯🇵Funabashi, Chiba, Japan
Hidaka Orthopedic Hospital
🇯🇵Kurume, Fukuoka, Japan
CMAX Clinical Research Pty Ltd
🇦🇺Adelaide, South Australia, Australia
RMC Medical Research Ltd
🇳🇿Dunedin, Otago, New Zealand
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Capital Radiology-Clayton
🇦🇺Melbourne, Victoria, Australia
CCBR - Centro de Pesquisas e Analises Clinicas LTDA
🇧🇷Rio De Janeiro, RJ, Brazil
Medical Center "Health for all" - EOOD
🇧🇬Plovdiv, Bulgaria
"Medical Center Teodora" EOOD
🇧🇬Ruse, Bulgaria
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Clinical Trials Center Pharmacy
🇰🇷Seoul, Korea, Republic of
Pharmacy of Clinical Trial Center
🇰🇷Gwangju, Korea, Republic of
Medical Corporation Okimoto Clinic
🇯🇵Kure, Hiroshima, Japan
Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital
🇯🇵Kure, Hiroshima, Japan
Otago Radiology
🇳🇿Dunedin, Otago, New Zealand
Auckland Radiology Parnell Branch
🇳🇿Auckland, New Zealand
Republican Siauliai Hospital
🇱🇹Siauliai, Lithuania
Manila Doctors Hospital
🇵🇭Manila, Philippines
Clinical Research Pharmacy
🇰🇷Seoul, Korea, Republic of
South Pacific Clinical Trials
🇳🇿Auckland, New Zealand
Emeritus Research
🇦🇺Camberwell, Victoria, Australia
Granger Medical Clinic-Riverton
🇺🇸Riverton, Utah, United States
Southern Radiology
🇦🇺Miranda, New South Wales, Australia
Hunter Imaging Group
🇦🇺Cardiff, New South Wales, Australia
Kobe Red Cross Hospital
🇯🇵Kobe, Hyogo, Japan
Southern Clinical Trials- Waitemata Ltd
🇳🇿Auckland, New Zealand
Southern Clinical Trials Ltd
🇳🇿Christchurch, New Zealand
Diagnostic Consultative Center 17 Sofia EOOD
🇧🇬Sofia, Bulgaria
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
🇧🇷Sao Paulo, SP, Brazil
Porter Rheumatology Ltd
🇳🇿Nelson, New Zealand
Okubo Hospital
🇯🇵Akashi, Hyogo, Japan
Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
ClinRX Research
🇺🇸Richardson, Texas, United States
Clinical Investigations of Texas
🇺🇸Plano, Texas, United States
Consultorio Medico del Dr. Federico Galvan Villegas
🇲🇽Guadalajara, Jalisco, Mexico
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
Chihaya Hospital
🇯🇵Fukuoka, Japan
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Reumatologia s.r.o.
🇸🇰Bratislava, Slovakia
Optimal Clinical Trials
🇳🇿Auckland, New Zealand
North Shore Hospital, Waitemata District Health Board
🇳🇿Auckland, New Zealand
Centro de Investigación Reumatología CAA-Clinica Anglo Americana
🇵🇪Lima, Peru
UMHAT Kaspela - EOOD
🇧🇬Plovdiv, Bulgaria
Obase Hospital
🇯🇵Miyako-gun, Fukuoka, Japan
Zenshukai Hospital
🇯🇵Maebashi, Gunma, Japan
Department of Radiology
🇰🇷Seoul, Korea, Republic of
Mazda Hospital
🇯🇵Aki-gun, Hiroshima, Japan
FSBI 'SRITO n.a. R.R. Vreden' MoH RF
🇷🇺Saint Petersburg, Russian Federation
Special Hospital for Rheumatic Diseases Novi Sad
🇷🇸Novi Sad, Serbia
MEDIPA s.r.o.
🇸🇰Piestany, Slovakia
Institute for Rehabilitation
🇷🇸Belgrade, Serbia
Changhua Christian Hospital
🇨🇳Changhua, Taiwan
Chang Gung Memorial Hospital-Kaohsiung Branch
🇨🇳Kaohsiung, Taiwan
Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council
🇺🇦Kharkiv, Ukraine
Institute of Rheumatology
🇷🇸Belgrade, Serbia
Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves
🇸🇰Bratislava, Slovakia
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Department of Pharmacy, China Medical University Hospital
🇨🇳Taichung, Taiwan
AusTrials Pty Ltd
🇦🇺Sherwood, Queensland, Australia
Royal Adelaide Hospital Pharmacy
🇦🇺Adelaide, South Australia, Australia
Bensons Radiology
🇦🇺North Adelaide, South Australia, Australia
CITrials
🇺🇸Santa Ana, California, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Triwest Research Associates, LLC
🇺🇸El Cajon, California, United States
T. Joseph Raoof MD, INC/Encino Research Center
🇺🇸Encino, California, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
IMD Medical Group
🇺🇸Los Angeles, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Prohealth Advanced Imaging
🇺🇸West Hills, California, United States
Medvin Clinical Research
🇺🇸Whittier, California, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Clinical Physiology Associates
🇺🇸Fort Myers, Florida, United States
South Florida Clinical Trials
🇺🇸Hialeah, Florida, United States
Tampa Bay Medical Research, Inc
🇺🇸Clearwater, Florida, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clintex Research Group
🇺🇸Miami, Florida, United States
Sensible Healthcare, LLC.
🇺🇸Ocoee, Florida, United States
Royal Hospital for Women
🇦🇺Randwick, New South Wales, Australia
Castlereagh Imaging
🇦🇺St Leonards, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Australian Clinical Research Network
🇦🇺Sydney, New South Wales, Australia
Spectrum Medical Imaging
🇦🇺Sydney, New South Wales, Australia
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States
Kennedy White Orthopaedic Center
🇺🇸Sarasota, Florida, United States
Phoenix Clinical Research, LLC.
🇺🇸Tamarac, Florida, United States
Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic
🇺🇸Atlanta, Georgia, United States
Better Health Clinical Research, Inc.
🇺🇸Newnan, Georgia, United States
Masters of Clinical Research, Inc.
🇺🇸Augusta, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
OrthoIllinois
🇺🇸Rockford, Illinois, United States
Quest Diagnostics
🇺🇸Rockford, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Onyx Clinical Research
🇺🇸Caro, Michigan, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
Wake Internal Medicine Consultants, Inc
🇺🇸Raleigh, North Carolina, United States
Valley Medical Research/Valley Medical Primary Care
🇺🇸Centerville, Ohio, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Remington-Davis, Incorporated
🇺🇸Columbus, Ohio, United States
Optimed Research LTD
🇺🇸Columbus, Ohio, United States
Dayton Clinical Research
🇺🇸Dayton, Ohio, United States
PriMed Clinical Research
🇺🇸Dayton, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Springboro Health Center
🇺🇸Springboro, Ohio, United States
Glendale Medical Center
🇺🇸Toledo, Ohio, United States
Bone Joint & Spine Surgeons, Inc.
🇺🇸Toledo, Ohio, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
University Orthopedics Center
🇺🇸Altoona, Pennsylvania, United States
Clinical Research Center of Reading, LLC
🇺🇸Wyomissing, Pennsylvania, United States
Galenos Research
🇺🇸Dallas, Texas, United States
Texas Orthopedic Specialists, PLLC
🇺🇸Bedford, Texas, United States
Advances in Health
🇺🇸Houston, Texas, United States
Mercury Clinical Research, Inc.
🇺🇸Houston, Texas, United States
Memorial Pulmonology
🇺🇸Houston, Texas, United States
BI Research Center
🇺🇸Houston, Texas, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
Lee Medical Associates PA
🇺🇸San Antonio, Texas, United States
National Clinical Research-Norfolk, Inc.
🇺🇸Norfolk, Virginia, United States
Mercury Clinical Research
🇺🇸Webester, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
ClinPoint Trials
🇺🇸Waxahachie, Texas, United States
Envision Imaging
🇺🇸Southlake, Texas, United States
Clinics of North Texas
🇺🇸Wichita Falls, Texas, United States
Oakbend Medical Center
🇺🇸Sugar Land, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Millennium Clinical Trials
🇺🇸Fairfax, Virginia, United States
Star Unit, North Shore Hospital, Waitemata District Health Board
🇳🇿Auckland, New Zealand
Collingwood Street Pharmacy
🇳🇿Nelson, New Zealand
Bay Radiology
🇳🇿Tauranga, New Zealand
P3 Research Ltd
🇳🇿Wellington, New Zealand
Pacific Radiology
🇳🇿Wellington, New Zealand
Clinical Horizons NZ Ltd
🇳🇿Tauranga, New Zealand
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center
🇺🇸Lake Success, New York, United States
NYU Langone Rheumatology Associates Long Island
🇺🇸Lake Success, New York, United States
Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
Herman Clinical Research, LLC
🇺🇸Suwanee, Georgia, United States
AC Clinical Research
🇺🇸Tiffin, Ohio, United States
Heritage Valley Medical Group, Inc.
🇺🇸Beaver, Pennsylvania, United States
Care Partners Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Optimed Research, LTD
🇺🇸Bellingham, Washington, United States
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center
🇺🇸Lake Success, New York, United States
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Aventiv Research Inc.
🇺🇸Columbus, Ohio, United States
Brandywine Clinical Research
🇺🇸Downingtown, Pennsylvania, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Millennium Clinical Trials, LLC
🇺🇸Arlington, Virginia, United States
Department of Orthopedic Surgery, Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Nelson Radiology
🇳🇿Nelson, New Zealand
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
University of California, Davis Health System
🇺🇸Sacramento, California, United States
University of California, Davis Medical Center
🇺🇸Sacramento, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Center for Clinical Trials of Sacramento, Inc.
🇺🇸Sacramento, California, United States
Rheumatology Associates of Central Florida, P.A.
🇺🇸Orlando, Florida, United States
Omega Research Consultants, LLC
🇺🇸Orlando, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
BayCare Medical Group, Inc
🇺🇸Tampa, Florida, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
IMA
🇺🇸Fort Myers, Florida, United States
Chair of Internal Medicine #2
🇺🇦Kyiv, Ukraine
Chrystal Johnson
🇺🇸Little Rock, Arkansas, United States
Valley Pain Consultants
🇺🇸Scottsdale, Arizona, United States
CHI St. Vincent Medical Group Hot Springs
🇺🇸Hot Springs, Arkansas, United States
Javed Rheumatology Associates, Inc.
🇺🇸Newark, Delaware, United States
Advanced Clinical Research
🇺🇸Meridian, Idaho, United States
Diagnostic Imaging PC
🇺🇸Memphis, Tennessee, United States
Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Physicians Quality Care
🇺🇸Jackson, Tennessee, United States
National Hospital Organization Kanazawa Medical Center
🇯🇵Kanazawa, Ishikawa, Japan
Kokan Clinic
🇯🇵Kawasaki, Kanagawa, Japan
Sato Orthopaedic Clinic
🇯🇵Edogawa-ku, Tokyo, Japan
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
🇯🇵Yonago, Tottori, Japan
National Hospital Organization Chiba Medical Center
🇯🇵Chiba, Japan
Hiroshima Prefectural Hospital
🇯🇵Hiroshima, Japan
Nagayoshi General Hospital
🇯🇵Osaka, Japan
Misugikai Medical Corporation Otokoyama Hospital
🇯🇵Yawata, Kyoto, Japan
Nakajo Orthopedic Clinic
🇯🇵Sendai, Miyagi, Japan
Marunouchi Hospital
🇯🇵Matsumoto, Nagano, Japan
Sobajima Clinic/Orthopedics
🇯🇵Higashiosaka, Osaka, Japan
Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital
🇯🇵Osaka-shi, Osaka, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Medical Plaza Edogawa
🇯🇵Edogawa-ku, Tokyo, Japan
Kumamoto Orthopaedic Hospital
🇯🇵Kumamoto, Japan
Iwasaki Orthopedic Surgery
🇯🇵Saitama, Japan
Tamagawa Hospital
🇯🇵Setagaya-ku, Tokyo, Japan
Fussa Hospital
🇯🇵Fussa, Tokyo, Japan
Centro Hospitalario Mac, S.A. de C.V.
🇲🇽Guadajara, Jalisco, Mexico
Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.
🇵🇪Lima, Peru
Federal State Budgetary Scientific Research institution of fundamental and clinical immunology
🇷🇺Novosibirsk, Russian Federation
Federal State Budgetary Scientific Institution
🇷🇺Novosibirsk, Russian Federation
Regional Communal Institution Chernivtsi Regional Clinical Hospital
🇺🇦Chernivtsi, Ukraine
Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy
🇨🇳Kaohsiung, Taiwan
Chung Shan Medical University Hospital Clinical Trial Pharmacy
🇨🇳Taichung, Taiwan
Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,
🇺🇦Kyiv, Ukraine
Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company
🇺🇦Kyiv, Ukraine
Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"
🇺🇦Kyiv, Ukraine
Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine
🇺🇦Kyiv, Ukraine
National Medical University named after O O Bogomolets,
🇺🇦Kyiv, Ukraine
Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem
🇺🇦Kyiv, Ukraine
Communal Institution "Odesa Regional Clinical Hospital"
🇺🇦Odesa, Ukraine
Communal Institution Ternopil University Hospital
🇺🇦Ternopil, Ukraine
Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"
🇺🇦Vinnytsia, Ukraine
Communal Institution Zaporizhzhya Regional Clinical Hospital
🇺🇦Zaporizhzhya, Ukraine
SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"
🇷🇺Moscow, Russian Federation
SIMEDHealth, LLC
🇺🇸Gainesville, Florida, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
ARC Clinical Research at Wilson Parke
🇺🇸Austin, Texas, United States
Tekton Research, Inc.
🇺🇸Austin, Texas, United States
Central Kentucky Research Associates, Inc.
🇺🇸Lexington, Kentucky, United States
Albuquerque Clinical Trials, Inc.
🇺🇸Albuquerque, New Mexico, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
🇺🇸Albuquerque, New Mexico, United States
Lovelace Scientific Resources Inc.
🇺🇸Albuquerque, New Mexico, United States
Quality of Life Medical & Research Centers, LLC
🇺🇸Tucson, Arizona, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Delaware Arthritis
🇺🇸Lewes, Delaware, United States
Artemis Institute for Clinical Research
🇺🇸San Marcos, California, United States
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-ku, Tokyo, Japan
Moscow Municipal Rheumatology Center
🇷🇺Moscow, Russian Federation