MedPath

Tanezumab In Osteoarthritis Of The Knee (2)

Phase 3
Completed
Conditions
Osteoarthritis
Arthritis
Interventions
Biological: tanezumab 5 mg
Biological: tanezumab 10 mg
Other: placebo
Registration Number
NCT00830063
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
832
Inclusion Criteria
  • Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria
  • Pregnancy or intent to become pregnant
  • BMI greater than 39
  • other severe pain, significant cardiac, neurologic or cardiac disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2tanezumab 5 mg-
1tanezumab 10 mg-
4placebo-
3naproxen-
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)Baseline (Day 1), Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 16

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)Week 2, 4, 8, 12, 16

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 \[minimum affected\] to 5 \[maximum affected\], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)Baseline up to Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent \[%\]; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)Weeks 2, 4, 8, 12, 16

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\>=) 50 percent and \>=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was \>=20 percent and \>=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 \[minimum affected\] to 5 \[maximum affected\], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

Number of Days Participants Used Rescue MedicationWeek 2, 4, 8, 12, 16

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 12, 16

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

Amount of Rescue Medication TakenWeek 2, 4, 8, 12, 16

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)Baseline up to Week 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent \[%\]; \>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[minimum stiffness\] to 10 \[maximum stiffness\], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

Percentage of Participants Who Used Rescue MedicationWeek 2, 4, 8, 12, 16

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 \[minimum pain\] to 10 \[maximum pain\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \[minimum difficulty\] to 10 \[maximum difficulty\], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \[minimum stiffness\] to 10 \[maximum stiffness\], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 2, 4, 8, 12, 16

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)Baseline, Week 12, 16

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

Time to Discontinuation Due to Lack of EfficacyBaseline up to Week 16

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

Trial Locations

Locations (92)

Valley Research

🇺🇸

Fresno, California, United States

Holston Medical Group

🇺🇸

Kingsport, Tennessee, United States

Jeffrey D. Lieberman, MD

🇺🇸

Decatur, Georgia, United States

Marietta Rheumatology

🇺🇸

Marietta, Georgia, United States

Rehabilitation Institute of Chicago

🇺🇸

Chicago, Illinois, United States

Michael Clifford, MD

🇺🇸

Las Vegas, Nevada, United States

Hightop Medical Research Center

🇺🇸

Cincinnati, Ohio, United States

Hilltop Physicians Inc / Hightop Medical Research Center

🇺🇸

Cincinnati, Ohio, United States

Asif Cochinwala, MD, PA

🇺🇸

Houston, Texas, United States

Stamford Therapeutics Consortium

🇺🇸

Stamford, Connecticut, United States

Avail Clinical Research, LLC

🇺🇸

DeLand, Florida, United States

Kendall South Medical Center, Inc

🇺🇸

Miami, Florida, United States

MAPS Applied Research Center, Inc

🇺🇸

Edina, Minnesota, United States

Arizona Arthritis & Rheumatology Associates, P.C.

🇺🇸

Phoenix, Arizona, United States

Arizona Research Center

🇺🇸

Phoenix, Arizona, United States

Radiant Research San Antonio Northeast

🇺🇸

San Antonio, Texas, United States

Diagnostics Research Group

🇺🇸

San Antonio, Texas, United States

South Texas Radiology Group

🇺🇸

San Antonio, Texas, United States

Health Research Institute

🇺🇸

Oklahoma City, Oklahoma, United States

Quality Clinical Research, Inc.

🇺🇸

Omaha, Nebraska, United States

McFarland Clinic, PC

🇺🇸

Ames, Iowa, United States

Lawrence P McAdam, MD / A Medical Corporation

🇺🇸

Thousand Oaks, California, United States

Talbert Medical Group

🇺🇸

Huntington Beach, California, United States

Physician Pain Care

🇺🇸

Woodstock, Georgia, United States

Osteoporosis Medical Center

🇺🇸

Beverly Hills, California, United States

Clinical Research Advantage, Inc. / Mesa Family Medical Center, PC

🇺🇸

Mesa, Arizona, United States

The Arthritis Center

🇺🇸

Springfield, Illinois, United States

Progressive Medical Research

🇺🇸

Port Orange, Florida, United States

Arthritis and Osteoporosis Center of Maryland

🇺🇸

Frederick, Maryland, United States

Medical Advanced Pain Specialists

🇺🇸

Edina, Minnesota, United States

North Georgia Clinical Research

🇺🇸

Woodstock, Georgia, United States

Illinois Bone and Joint Institute, LLC

🇺🇸

Morton Grove, Illinois, United States

Professional Research Network of Kansas, LLC

🇺🇸

Wichita, Kansas, United States

North Georgia Internal Medicine

🇺🇸

Woodstock, Georgia, United States

Albuquerque Clinical Trials, Inc.

🇺🇸

Albuquerque, New Mexico, United States

Odyssey Research

🇺🇸

Fargo, North Dakota, United States

Pharmquest

🇺🇸

Greensboro, North Carolina, United States

Plains Medical Clinic, LLC

🇺🇸

Fargo, North Dakota, United States

Andrew J. Porges, MD, PC

🇺🇸

Roslyn, New York, United States

Carolina Bone and Joint, PA

🇺🇸

Charlotte, North Carolina, United States

Pharmacotherapy Research Associates Incorporated

🇺🇸

Zanesville, Ohio, United States

Altoona Center for Clinical Research

🇺🇸

Duncansville, Pennsylvania, United States

Southwest Rheumatology and Research Group, LLC

🇺🇸

Middleburg Heights, Ohio, United States

Clinical Research Center of Reading, LLP

🇺🇸

West Reading, Pennsylvania, United States

Diagnostic Research Group

🇺🇸

San Antonio, Texas, United States

Capitol Medical Clinic

🇺🇸

Austin, Texas, United States

Pioneer Research Solutions, Inc

🇺🇸

Houston, Texas, United States

Aspen Clinical Research, LLC

🇺🇸

Orem, Utah, United States

National Clinical Research - Norfolk, Inc.

🇺🇸

Norfolk, Virginia, United States

Clinical Trials Northwest

🇺🇸

Yakima, Washington, United States

University of Arizona - Arizona Arthritis Center

🇺🇸

Tucson, Arizona, United States

UC Davis Medical Center

🇺🇸

Sacramento, California, United States

David H. Neustadt, PSC

🇺🇸

Louisville, Kentucky, United States

University of Arizona

🇺🇸

Tucson, Arizona, United States

Anniston Medical Clinic, PC

🇺🇸

Anniston, Alabama, United States

Pinnaccle Research Group, LLC

🇺🇸

Anniston, Alabama, United States

Arthritis and Rheumatology of Georgia

🇺🇸

Atlanta, Georgia, United States

Northwest Indiana Center for Clinical Research

🇺🇸

Valparaiso, Indiana, United States

Integrated Clinical Trial Services, Inc.

🇺🇸

West Des Moines, Iowa, United States

Koch Family Practice

🇺🇸

Morton, Illinois, United States

Mercy Health Research

🇺🇸

Saint Louis, Missouri, United States

The Medical Research Network, LLC

🇺🇸

New York, New York, United States

AAIR Research Center

🇺🇸

Rochester, New York, United States

Coastal Carolina Research Center

🇺🇸

Mount Pleasant, South Carolina, United States

Health Concepts

🇺🇸

Rapid City, South Dakota, United States

Appalachian Medical Research, Inc

🇺🇸

Johnson City, Tennessee, United States

North Texas Joint Care, PA

🇺🇸

Dallas, Texas, United States

Arthritis and Rheumatic Diseases

🇺🇸

Portsmouth, Virginia, United States

Innovative Research of West Florida, Inc

🇺🇸

Clearwater, Florida, United States

Tampa Bay Medical Research, Inc.

🇺🇸

Clearwater, Florida, United States

Pivotal Research Centers

🇺🇸

Peoria, Arizona, United States

St. Joseph's Mercy Clinic

🇺🇸

Hot Springs, Arkansas, United States

Javed Rheumatology Associates, Inc.

🇺🇸

Newark, Delaware, United States

Clinical Research of South Florida

🇺🇸

Coral Gables, Florida, United States

Adult Medicine Specialists

🇺🇸

Longwood, Florida, United States

Sonora Clinical Research

🇺🇸

Boise, Idaho, United States

Westside Center for Clinical Research

🇺🇸

Jacksonville, Florida, United States

Stanocola Medical Center

🇺🇸

Baton Rouge, Louisiana, United States

Comprehensive Clinical Research

🇺🇸

Berlin, New Jersey, United States

Clinical Research Consortium

🇺🇸

Las Vegas, Nevada, United States

Shores Rheumatology, P.C.

🇺🇸

Saint Clair Shores, Michigan, United States

University Clinical Research, Inc.

🇺🇸

Pembroke Pines, Florida, United States

Maine Research Associates

🇺🇸

Auburn, Maine, United States

Palm Beach Research Center

🇺🇸

West Palm Beach, Florida, United States

Mirkil Medical

🇺🇸

Las Vegas, Nevada, United States

G. Timothy Kelly, MD

🇺🇸

Las Vegas, Nevada, United States

Clinical Pharmacology Study Group

🇺🇸

Worcester, Massachusetts, United States

West Broward Rheumatology Associates, Inc.

🇺🇸

Tamarac, Florida, United States

Office of Walter F Chase, MD, PA

🇺🇸

Austin, Texas, United States

New Mexico Clinical Research & Osteoporosis Center, Incorporated

🇺🇸

Albuquerque, New Mexico, United States

The Center for Rheumatology and Bone Research

🇺🇸

Wheaton, Maryland, United States

Genesis Research International

🇺🇸

Longwood, Florida, United States

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