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A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02629159
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo for Adalimumab Drug: Adalimumab Drug: Placebo for Upadacitinib Drug: Upadacitinib Phase 3

Detailed Description:

This study consists of a 48-week double-blind treatment period (Period 1) and a long-term extension period (Period 2).

Period 1 is a 48-week randomized, double-blind, parallel-group, placebo-controlled and active comparator-controlled period designed to compare the safety and efficacy of upadacitinib versus placebo, and versus adalimumab. Participants will be randomized in a 2:2:1 ratio to one of three treatment groups:

  • Placebo (up to Week 26)
  • Upadacitinib 15 mg once daily (QD)
  • Adalimumab 40 mg every other week (eow)

Participants randomized to placebo who do not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib treatment. At Week 26, all participants still receiving placebo will be switched to blinded upadacitinib treatment regardless of clinical response.

Participants randomized to adalimumab who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib. Participants still receiving adalimumab at Week 26 who do not achieve low disease activity (LDA) according to Clinical Disease Activity Index (CDAI; LDA is defined as CDAI ≤ 10) will be switched to blinded upadacitinib treatment to Week 48.

Participants randomized to upadacitinib who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded adalimumab; participants still receiving upadacitinib at Week 26 who do not achieve LDA (CDAI ≤ 10) will be switched to blinded adalimumab treatment to Week 48.

Participants who complete the Week 48 visit (end of Period 1) will enter the long-term extension phase of the study (Period 2), for up to 5 years. Participants will continue study treatment as assigned at the end of Period 1. Starting at the Week 48 and thereafter, at least 20% improvement in both TJC and SJC compared to Baseline is required to remain on study drug. Anyone who does not fulfill this criterion at 2 consecutive visits (starting at Week 48) will be discontinued.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1629 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : October 27, 2017
Estimated Study Completion Date : May 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Placebo Comparator: Placebo followed by ABT-494

Participants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1).

Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.

Drug: Placebo for Adalimumab
Administered by subcutaneous injection once every other week

Drug: Placebo for Upadacitinib
Tablets taken orally once a day

Drug: Upadacitinib
Tablets taken orally once a day
Other Name: ABT-494

Active Comparator: Adalimumab

Participants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48.

Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.

Drug: Adalimumab
Administered by subcutaneous injection once every other week
Other Name: Humira

Drug: Placebo for Upadacitinib
Tablets taken orally once a day

Drug: Upadacitinib
Tablets taken orally once a day
Other Name: ABT-494

Experimental: Upadacitinib

Participants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48.

Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.

Drug: Placebo for Adalimumab
Administered by subcutaneous injection once every other week

Drug: Adalimumab
Administered by subcutaneous injection once every other week
Other Name: Humira

Drug: Upadacitinib
Tablets taken orally once a day
Other Name: ABT-494




Primary Outcome Measures :
  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

    The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:

      • Physician global assessment of disease activity
      • Patient global assessment of disease activity
      • Patient assessment of pain
      • Health Assessment Questionnaire - Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP).

  2. Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12 [ Time Frame: Week 12 ]

    The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 12.

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28 score less than 2.6 indicates clinical remission.



Secondary Outcome Measures :
  1. Change From Baseline in DAS28 (CRP) at Week 12 [ Time Frame: Baseline and Week 12 ]
    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

  2. Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26 [ Time Frame: Baseline and Week 26 ]

    The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.

    Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

    JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

    The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.


  3. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 [ Time Frame: Baseline and Week 12 ]

    The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

    A negative change from Baseline in the overall score indicates improvement.


  4. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:

      • Physician global assessment of disease activity
      • Patient global assessment of disease activity
      • Patient assessment of pain
      • Health Assessment Questionnaire - Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP).

  5. Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 [ Time Frame: Baseline and Week 12 ]

    The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

    The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement.


  6. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 [ Time Frame: Week 12 ]

    The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.


  7. Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12 [ Time Frame: Week 12 ]

    Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.

    CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.


  8. Change From Baseline in Duration of Morning Stiffness at Week 12 [ Time Frame: Baseline and Week 12 ]
    Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.

  9. Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: Baseline and Week 12 ]
    The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.

  10. Change From Baseline in Patient's Assessment of Pain at Week 12 [ Time Frame: Baseline and Week 12 ]
    Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.

  11. Percentage of Participants With No Radiographic Progression at Week 26 [ Time Frame: Baseline and Week 26 ]

    No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).

    Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).

    Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).


  12. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:

      • Physician global assessment of disease activity
      • Patient global assessment of disease activity
      • Patient assessment of pain
      • Health Assessment Questionnaire - Disability Index (HAQ-DI)
      • High-sensitivity C-reactive protein (hsCRP).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male or female, at least 18 years old.
  • Diagnosis of RA for greater than or equal to 3 months.
  • Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
  • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
  • Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
  • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629159


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Locations
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United States, Alabama
Achieve Clinical Research, LLC /ID# 143136
Birmingham, Alabama, United States, 35216
United States, Arizona
AZ Arthritis and Rheum Assoc /ID# 143130
Mesa, Arizona, United States, 85202
SunValley Arthritis Center, Lt /ID# 143123
Peoria, Arizona, United States, 85381
Elite Clinical Studies, LLC /ID# 144881
Phoenix, Arizona, United States, 85018
AZ Arthritis and Rheum Researc /ID# 143080
Phoenix, Arizona, United States, 85032-9306
AZ Arthritis and Rheum Researc /ID# 143121
Phoenix, Arizona, United States, 85032-9306
AZ Arthritis & Rheuma Research /ID# 143131
Phoenix, Arizona, United States, 85032
Arizona Research Center, Inc. /ID# 144877
Phoenix, Arizona, United States, 85053-4061
AZ Arthritis & Rheum Research /ID# 156093
Sun City, Arizona, United States, 85351
University of Arizona Cancer Center - North Campus /ID# 143114
Tucson, Arizona, United States, 85719-1478
United States, California
Osteoporosis Medical Center /ID# 153935
Beverly Hills, California, United States, 90211
T. Joseph Raoof, MD, Inc. /ID# 144884
Encino, California, United States, 91436
Rheumatology Ctr of San Diego /ID# 153747
Escondido, California, United States, 92025
C.V. Mehta MD, Med Corporation /ID# 143116
Hemet, California, United States, 92543
Allergy and Rheum Med Clin /ID# 146083
La Jolla, California, United States, 92037
Kotha and Kotha /ID# 161046
La Mesa, California, United States, 91942
TriWest Research Associates- La Mesa /ID# 143115
La Mesa, California, United States, 91942
Valerius Med Grp & Res Ctr /ID# 143120
Los Alamitos, California, United States, 90720-5402
Discovery MM Services, Inc /ID# 163504
Los Angeles, California, United States, 11373
Desert Medical Advances /ID# 143097
Palm Desert, California, United States, 92260
Sierra Rheumatology /ID# 155672
Roseville, California, United States, 95661
Robin K. Dore MD, Inc /ID# 143090
Tustin, California, United States, 92780
Medvin Clinical Research /ID# 148362
Whittier, California, United States, 90606
United States, Colorado
Arthritis Assoc & Osteo Ctr /ID# 143122
Colorado Springs, Colorado, United States, 80920
Arthritis and Rheum Clin N. CO /ID# 156094
Fort Collins, Colorado, United States, 80528
United States, Florida
AARDS Research, Inc. /ID# 154190
Aventura, Florida, United States, 33180
ZASA Clinical Research /ID# 143134
Boynton Beach, Florida, United States, 33472
Clinical Res of West FL, Inc. /ID# 143112
Clearwater, Florida, United States, 33765
International Medical Research /ID# 143132
Daytona Beach, Florida, United States, 32117
Precision Research Org, LLC /ID# 143092
Miami Lakes, Florida, United States, 33016-1501
Lakes Research, LLC /ID# 145630
Miami, Florida, United States, 33014
FL Med Ctr and Research, Inc. /ID# 143081
Miami, Florida, United States, 33142
Ctr Arthritis & Rheumatic Dise /ID# 143135
Miami, Florida, United States, 33173
Advanced Clin Res of Orlando /ID# 154617
Ocoee, Florida, United States, 34761-4547
Rheum Assoc of Central FL /ID# 145632
Orlando, Florida, United States, 32806
Omega Research Consultants /ID# 145635
Orlando, Florida, United States, 32810
HMD Research LLC /ID# 163292
Orlando, Florida, United States, 32819
Arthritis Research of Florida /ID# 143125
Palm Harbor, Florida, United States, 34684-2672
Arthritis Center, Inc. /ID# 145647
Palm Harbor, Florida, United States, 34684
St. Anthony Comprehsve Res Ins /ID# 143095
Saint Petersburg, Florida, United States, 33705
Clinical Research West FL /ID# 148358
Tampa, Florida, United States, 33603
SW FL Clin Res Ctr, Tampa, FL /ID# 143117
Tampa, Florida, United States, 33609
BayCare Medical Group, Inc. /ID# 143085
Tampa, Florida, United States, 33614-7101
Lovelace Scientific Resources /ID# 143106
Venice, Florida, United States, 34292
United States, Georgia
Arthritis and Rheumatology /ID# 155668
Atlanta, Georgia, United States, 30342
Arthritis Center of North GA /ID# 155258
Gainesville, Georgia, United States, 30501
North Georgia Rheumatology Grp /ID# 147170
Lawrenceville, Georgia, United States, 30045
United States, Idaho
Advanced Clinical Research /ID# 153090
Meridian, Idaho, United States, 83642
United States, Illinois
Great Lakes Clinical Trials /ID# 148357
Chicago, Illinois, United States, 60640
United States, Maryland
Arthritis Treatment Center /ID# 155260
Frederick, Maryland, United States, 21204
The Center for Rheumatology & /ID# 151356
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Clinical Pharmacology Study Gr /ID# 143082
Worcester, Massachusetts, United States, 01605
United States, Michigan
Advanced Rheumatology, PC /ID# 143118
Lansing, Michigan, United States, 48910
Shores Rheumatology, PC /ID# 162977
Saint Clair Shores, Michigan, United States, 48081
United States, Minnesota
St. Luke's Hospital /ID# 156750
Duluth, Minnesota, United States, 55805
United States, Mississippi
North Mississippi Med Clinics /ID# 145636
Tupelo, Mississippi, United States, 38801
United States, Nebraska
Physician Res. Collaboration /ID# 143087
Lincoln, Nebraska, United States, 68516
Quality Clinical Research Inc. /ID# 156394
Omaha, Nebraska, United States, 68114
United States, New Jersey
Atlantic Coast Research /ID# 148355
Toms River, New Jersey, United States, 08755
Ocean Rheumatology, PA /ID# 143111
Toms River, New Jersey, United States, 08755
Arthritis Rheumatic Back Disorder /ID# 143102
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque Clinical Trials, Inc /ID# 143083
Albuquerque, New Mexico, United States, 87102
Arthritis and Osteo Assoc /ID# 143127
Las Cruces, New Mexico, United States, 88011
United States, New York
St. Lawrence Health System /ID# 161619
Potsdam, New York, United States, 13676
United States, North Carolina
Joint & Muscle Research Instit /ID# 143119
Charlotte, North Carolina, United States, 28204
DJL Clinical Research, PLLC /ID# 143101
Charlotte, North Carolina, United States, 28210-8508
EmergeOrtho, P.A. /ID# 143100
Durham, North Carolina, United States, 27704
Cape Fear Arthritis Care /ID# 148361
Leland, North Carolina, United States, 28451
Coastal Carolina Health Care /ID# 148359
New Bern, North Carolina, United States, 28562
Shanahan Rheuma & Immuno /ID# 145643
Raleigh, North Carolina, United States, 27617
United States, Ohio
Clinical Research Solutions, LLC /ID# 154619
Dayton, Ohio, United States, 45409
Arthritis Assoc of NW Ohio /ID# 143094
Toledo, Ohio, United States, 43606
United States, Oklahoma
Healthcare Research Consultant /ID# 143129
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Altoona Ctr Clinical Res /ID# 143110
Duncansville, Pennsylvania, United States, 16635
Clinical Research Ctr Reading /ID# 143133
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Columbia Arthritis Center /ID# 153730
Columbia, South Carolina, United States, 29204
Innovative Clinical Research /ID# 145637
Greenville, South Carolina, United States, 29601
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091
Summerville, South Carolina, United States, 29486-7887
United States, Tennessee
Arthritis Associates, PLLC /ID# 155490
Kingsport, Tennessee, United States, 37660
Rheumatology Consultants, PLLC /ID# 153731
Knoxville, Tennessee, United States, 37909
Dr. Ramesh Gupta /ID# 143099
Memphis, Tennessee, United States, 38119
United States, Texas
Austin Regional Clinic /ID# 143084
Austin, Texas, United States, 78731
Diagnostic Group Integrated He /ID# 148356
Beaumont, Texas, United States, 77701
Arthritis Care and Diagnostic /ID# 150677
Dallas, Texas, United States, 75231
Metroplex Clinical Research /ID# 145631
Dallas, Texas, United States, 75231
Doctor's Hosp at Renaissance /ID# 154616
Edinburg, Texas, United States, 78539
MedResearch Inc. /ID# 154618
El Paso, Texas, United States, 79935
Accurate Clinical Management /ID# 145644
Houston, Texas, United States, 77004
Accurate Clinical Research /ID# 145645
Houston, Texas, United States, 77034
Rheumatology Clinic of Houston /ID# 150921
Houston, Texas, United States, 77065
Houston Institute for Clin Res /ID# 144879
Houston, Texas, United States, 77074
Pioneer Research Solutions, Inc. /ID# 145640
Houston, Texas, United States, 77098-5294
Arthritis Consultants, P.A. /ID# 144880
Killeen, Texas, United States, 76549
Arthritis & Osteoporosis Assoc /ID# 147364
Lubbock, Texas, United States, 79424
P&I Clinical Research /ID# 161625
Lufkin, Texas, United States, 75904-3132
SW Rheumatology Res. LLC /ID# 143126
Mesquite, Texas, United States, 75150
Discovery MM Services, Inc. /ID# 162578
Missouri City, Texas, United States, 77459-4750
Discovery MM Services, Inc. /ID# 163183
Missouri City, Texas, United States, 77459-4750
Discovery MM Services, Inc. /ID# 163184
Missouri City, Texas, United States, 77459-4750
Sun Research Institute /ID# 159539
San Antonio, Texas, United States, 78215
Accurate Clinical Management /ID# 143089
San Antonio, Texas, United States, 78229
Arthritis & Osteo Ctr of S. TX /ID# 143103
San Antonio, Texas, United States, 78232
DM Clinical Research /ID# 151357
Tomball, Texas, United States, 77375
United States, Virginia
Arthritis Clinic of N. VA, P.C /ID# 143109
Arlington, Virginia, United States, 22205
Ctr for Arth and Rheum Disease /ID# 143113
Chesapeake, Virginia, United States, 23320
United States, Washington
Arthritis Northwest, PLLC /ID# 143088
Spokane, Washington, United States, 99204
The Vancouver Clinic, INC. PS /ID# 143107
Vancouver, Washington, United States, 98664
United States, West Virginia
West Virginia Research Inst /ID# 153088
South Charleston, West Virginia, United States, 25309
United States, Wisconsin
Rheumatology and Immunotherapy Center /ID# 145646
Franklin, Wisconsin, United States, 53132
Argentina
Aprillus Asistencia e Investig /ID# 148406
Capital Federal, Buenos Aires, Argentina, 1046
Mautalen Salud e Investigacion /ID# 142843
Buenos Aires, Argentina, 1128
Fundacion Sanatorio Guemes /ID# 148405
Buenos Aires, Argentina, 1180
Consultorio Reumatologic Pampa /ID# 144853
Buenos Aires, Argentina, 1428
Cemic /Id# 148404
Buenos Aires, Argentina, 1431
Org Medica de Investigacion /ID# 144855
Buenos Aires, Argentina, C1015ABO
Inst. Rheumatologic Strusberg /ID# 145601
Cordoba, Argentina, 5000
Consultora Integral de Salud S /ID# 144856
Cordoba, Argentina, 5900
Instituto CAICI /ID# 144854
Rosario, Santa FE, Argentina, 2000
Cordis S.A. /Id# 152622
Salta, Argentina, 4400
Iari /Id# 151293
San Fernando, Argentina, 1646
Centro Integral de Reumatologi /ID# 142845
San Miguel de Tucuman, Argentina, 4000
Centro Medico Privado/Reuma /ID# 142842
San Miguel de Tucuman, Argentina, 4000
Centro de Enfermedades /ID# 153542
Santa Fe, Argentina, 2000
Australia, New South Wales
Royal Prince Alfred Hospital /ID# 144857
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Emeritus Research /ID# 142848
Camberwell, Victoria, Australia, 3124
Austria
LKH-Univ. Klinikum Graz /ID# 142851
Graz, Austria, 8036
Belarus
First City Clinical Hospital /ID# 158011
Minsk, Belarus, 220013
Belgium
Cliniques Universitaires Saint Luc /ID# 142858
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Rhumaconsult SPRL /ID# 142860
Charleroi, Hainaut, Belgium, 6000
CHU de Liege /ID# 148401
Liège, Liege, Belgium, 4000
UZ Gent /ID# 142859
Gent, Oost-Vlaanderen, Belgium, 9000
CHU Ambroise Pare /ID# 152953
Mons, Belgium, 7000
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 142862
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 142863
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
Clinical Center University of Sarajevo /ID# 142865
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
CIP - Centro Internacional de Pesquisa /ID# 142872
Goiânia, Goias, Brazil, 74110-120
Hc Ufmg /Id# 142868
Belo Horizonte, Minas Gerais, Brazil, 30130-100
Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871
Curitiba, Parana, Brazil, 80030-110
Hospital de Clinicas de Porto Alegre /ID# 142870
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
LMK Sevicos Medicos S/S /ID# 142869
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867
São Paulo, Sao Paulo, Brazil, 04266-010
CCBR Brasil /ID# 150918
Rio de Janeiro, Brazil, 22271-100
Bulgaria
MHAT Trimontsium /ID# 142874
Plovdiv, Bulgaria, 4000
UMHAT Pulmed OOD /ID# 142877
Plovdiv, Bulgaria, 4000
MHAT Kaspela /ID# 142873
Plovdiv, Bulgaria, 4001
Diagnostic Consultative Center /ID# 142875
Sofia, Bulgaria, 1612
UMHAT Sv. Ivan Rilski /ID# 142876
Sofia, Bulgaria, 1612
Canada, Manitoba
Manitoba Clinic /ID# 161434
Winnipeg, Manitoba, Canada, R3A IM3
Ciads /Id# 142880
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Newfoundland and Labrador
St. Clare's Mercy Hospital /ID# 142879
St. John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Ontario
Adachi Medicine Prof. Corp /ID# 154205
Hamilton, Ontario, Canada, L8N 1Y2
CA Ctr for Clin Trials CCCT /ID# 157379
Thornhill, Ontario, Canada, L4J 1W3
Canada, Quebec
Groupe de Recherche en Maladies Osseuses /ID# 142878
Sainte-foy, Quebec, Canada, G1V 3M7
Chile
Ctr de Inv Clinica del Sur /ID# 142888
Temuco, Araucania, Chile, 4781156
Reg. Clinical Hosptial Concepcion /ID# 151271
Concepcion, Chile, 4070038
Corp de Beneficencia Osorno /ID# 147941
Osorno, Chile, 1710216
Someal /Id# 144704
Providencia-santiago, Chile, 7510186
Quantum Research LTDA. /ID# 142893
Puerto Varas, Chile, 5550170
Quantum Research Stgo. /ID# 157933
Santiago, Chile, 7500588
Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890
Santiago, Chile, 7510047
Clinica DermaCross /ID# 142892
Santiago, Chile, 7640881
Investigaciones Medicas SSMSO /ID# 151686
Santiago, Chile, 8207257
Centro Inter Estud Clin CIEC /ID# 144777
Santiago, Chile, 8420383
Centro Medico de Reumatologia /ID# 148402
Temuco, Chile, 4790928
Cinvec /Id# 144705
Vina Del Mar, Chile, 2520997
Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898
Bogota, Cundinamarca, Colombia, 110221
Ctr Int de Reum del Caribe SAS /ID# 142894
Barranquilla, Colombia, 80002
Fund Inst de Reum F. Chalem /ID# 149847
Bogota DC, Colombia
Riesgo de Fractura S.A - CAYRE /ID# 142896
Bogota, Colombia, 110221
Medicity S.A.S. /ID# 144860
Bucaramanga, Colombia, 680003
Centro Integral de Reumatologi /ID# 142897
Medellín, Colombia, 50021
Croatia
Klinicki bolnicki centar Rijeka /ID# 160232
Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
Klinicki bolnicki centar Split /ID# 152530
Split, Croatia, 21000
Clinical Hospital Dubrava /ID# 142900
Zagreb, Croatia, 10000
Medical Center Kuna-Peric /ID# 142901
Zagreb, Croatia, 10000
Poliklinika Bonifarm /ID# 142899
Zagreb, Croatia, 10000
Czechia
L.K.N. Arthrocentrum, s.r.o /ID# 145961
Hlučín, Moravskoslezsky Kraj, Czechia, 748 01
CTCenter MaVe, s.r.o. /ID# 142905
Olomouc, Olomoucky Kraj, Czechia, 779 00
Revmatologicky ustav Praha /ID# 142904
Prague 2, Praha 2, Czechia, 128 00
Nuselská poliklinika, Revmatologie /ID# 144862
Prague 4, Praha 4, Czechia, 140 00
Revmatologická ambulance /ID# 145963
Prague 4, Praha 4, Czechia, 140 00
Thomayerova nemocnice /ID# 145962
Prague 4, Praha 4, Czechia, 140 00
REVMACLINIC s.r.o. /ID# 142906
Brno, Czechia, 611 41
Revmatologie Bruntal, s.r.o /ID# 142903
Bruntál, Czechia, 79201
Revmatologicka a interni ambul /ID# 142907
Kladno, Czechia, 272 01
Revmatologie MUDr. Klara Sirov /ID# 142908
Ostrava, Czechia, 702 00
Arthromed, s.r.o. /ID# 144706
Pardubice, Czechia, 530 02
Denmark
Aarhus University Hospital /ID# 158838
Aarhus N, Midtjylland, Denmark, 8200
Regionhospital Silkeborg /ID# 142914
Silkeborg, Denmark, 8600
Estonia
Center of Clinical and Basic Research /ID# 142922
Tallinn, Harjumaa, Estonia, 10128
MediTrials /ID# 151870
Tartu, Tartumaa, Estonia, 50406
Paernu Hospital /ID# 142921
Pärnu, Estonia, 80010
East Tallinn Central Hospital /ID# 142923
Tallinn, Estonia, 10138
North Estonian Medical Centre /ID# 145454
Tallinn, Estonia, 13419
France
Hopital Universitaire Purpan /ID# 144707
Toulouse, Haute-Garonne, France, 31059
CHRU Lille - Hôpital Claude Huriez /ID# 151312
Lille CEDEX, Hauts-de-France, France, 59045
Hopital Saint Eloi /ID# 142925
Montpellier CEDEX 5, Herault, France, 34295
CHU Bordeaux-Hopital Pellegrin /ID# 145618
Bordeaux, France, 33076
Hopital de la Cote de Nacre /ID# 145616
Caen, France, 14033
CHU Gabriel Montpied /ID# 145619
Clermont Ferrand, France, 63000
Hopital de la Conception /ID# 142926
Marseille, France, 13005
Hopital Pitie Salpetriere /ID# 145605
Paris, France, 75651
CHU de Rennes - Hospital Sud /ID# 151957
Rennes, France, 35203
CHU Strasbourg Hautepierre Hos /ID# 144708
Strasbourg, France, 67200
Germany
Rheumazentrum Ruhrgebiet /ID# 145620
Herne, Nordrhein-Westfalen, Germany, 44649
Uniklinik Koln /ID# 145964
Köln, Nordrhein-Westfalen, Germany, 50937
Praxis Walter, Rendsburg /ID# 142932
Rendsburg, Schleswig-Holstein, Germany, 24768
Med Versorgungszentrum AGILOME /ID# 154975
Chemnitz, Germany, 9126
Rheumaforschungszentrum II /ID# 142930
Hamburg, Germany, 20095
LMU Klinikum der Universität München /ID# 142931
Munich, Germany, 80337
Greece
General Hospital of Athens Laiko /ID# 142934
Athens, Attiki, Greece, 115 27
University General Hospital Attikon /ID# 142933
Athens, Attiki, Greece, 12462
General Hospital of Athens Ippokratio /ID# 142935
Athens, Greece, 11527
Hong Kong
Queen Mary Hospital /ID# 142938
Hong Kong, Hong Kong, 999077
Tuen Mun Hospital /ID# 142939
Tuen Mun, Hong Kong, 999077
Hungary
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951
Miskolc, Borsod-Abauj-Zemplen, Hungary, 3529
Qualiclinic Kft. /ID# 142953
Budapest III, Pest, Hungary, 1036
Markusovszky Egyetemi Oktatókórház /ID# 145621
Szombathely, Vas, Hungary, 9700
Vital Medical Center Orvosi es /ID# 145950
Veszprém, Veszprem, Hungary, 8200
Budai Irgalmasrendi Korhaz /ID# 142952
Budapest, Hungary, 1023
Revita Reumatologiai Rendelo /ID# 142950
Budapest, Hungary, 1027
Synexus Magyarorszag Kft. /ID# 153061
Budapest, Hungary, 1036
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948
Debrecen, Hungary, 4031
Hevizgyogyfurdo es Szent Andra /ID# 142949
Heviz, Hungary, 8380
Kiskunhalasi Semmelweis Korhaz /ID# 151944
Kiskunhalas, Hungary, 6400
Pest Megyei Flor Ferenc Korhaz /ID# 142954
Kistarcsa, Hungary, 2143
Ireland
St Vincent's University Hosp /ID# 142957
Dublin, Ireland, D04 T6F4
Israel
Tel Aviv Sourasky Medical Ctr /ID# 144709
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Rambam Health Care Campus /ID# 152050
Haifa, Israel, 3109601
Bnai Zion Medical Center /ID# 151958
Haifa, Israel, 3339419
The Lady Davis Carmel MC /ID# 142960
Haifa, Israel, 3436212
Sheba Medical Center /ID# 145965
Ramat Gan, Israel, 5262100
Italy
Istituto Clinico Humanitas /ID# 147528
Rozzano, Milano, Italy, 20089
AOU Citta della Salute Scienza /ID# 150070
Turin, Piemonte, Italy, 10126
Azienda Ospedaliera Luigi Sacc /ID# 142966
Milan, Italy, 20157
A.O.U.I. di Verona Policlinico /ID# 142963
Verona, Italy, 37134
Kazakhstan
JSC Nat Scientific Med Res Ctr /ID# 142971
Astana, Kazakhstan, 010009
Karaganda State Medical Univ /ID# 153433
Karaganda, Kazakhstan, 100008
Semey State Medical University /ID# 152659
Semey, Kazakhstan, 071403
Regional Clinical Hospital /ID# 147168
Shymkent, Kazakhstan, 160000
Korea, Republic of
Kyungpook National Univ Hosp /ID# 162073
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 41944
Chungnam National University Hospital /ID# 142977
Jung-gu, Daejeon Gwang Yeogsi, Korea, Republic of, 35015
Inha University Hospital /ID# 150886
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Chonnam National University Hospital /ID# 142975
Gwangju, Jeonranamdo, Korea, Republic of, 61469
Hanyang University Seoul Hospi /ID# 142979
Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of, 04763
Cath Univ Seoul St Mary's Hosp /ID# 142976
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
Daegu Catholic University Med /ID# 142973
Daegu, Korea, Republic of, 705-718
Seoul National University Hospital /ID# 142978
Seoul, Korea, Republic of, 03080
Asan Medical Center /ID# 142974
Seoul, Korea, Republic of, 05505
Latvia
LTD M+M Centers /ID# 142984
Adazi, Latvia, 2164
Daugavpils Regional Hospital /ID# 142982
Daugavpils, Latvia, 5417
D.Saulites-Kandevicas PP /ID# 142985
Liepaja, Latvia, 3401
Clinic ORTO /ID# 142983
Riga, Latvia, 1005
Riga East Clinical Univ Hosp /ID# 142981
Riga, Latvia, 1038
Lithuania
Hosp Lithuanian Univ Health Sc /ID# 142986
Kovno, Kaunas, Lithuania, 50009
Vilnius University Hospital /ID# 142987
Vilnius, Lithuania, LT-08661
Malaysia
Hospital Raja Perempuan Zainab II /ID# 157862
Kota Bharu, Kelantan, Malaysia, 15586
Hospital Selayang /ID# 156756
Batu Caves, Malaysia, 68100
Hospital Umum Sarawak /ID# 142990
Kuching, Malaysia, 93586
Hospital Putrajaya /ID# 142989
Putrajaya, Malaysia, 62250
Hospital Tuanku Ja afar /ID# 142988
Seremban, Malaysia, 70300
Mexico
Clinstile, S.A. de C.V. /ID# 144866
Cuauhtemoc, Ciudad De Mexico, Mexico, 06700
Hosp. Univ. Dr. Jose E. Gonz /ID# 142992
Monterrey, Nuevo Leon, Mexico, 64320
Invest y Biomed de Chihuahua /ID# 142996
Chihuahua, Mexico, 31000
RM Pharma Specialists, S.A de C.V /ID# 142994
Mexico City, Mexico, 03100
Hospital de Jesús Nazareno /ID# 142993
Mexico City, Mexico, 06090
Centro Peninsular de Investiga /ID# 148159
Mérida, Mexico, 97000
New Zealand
Waikato Hospital /ID# 143002
Hamilton, Waikato, New Zealand, 3204
Porter Rheumatology Ltd /ID# 143001
Nelson, New Zealand, 7010
Timaru Medical Specialists Ltd /ID# 143000
Timaru, New Zealand, 7910
Poland
WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622
Wrocław, Dolnoslaskie, Poland, 51-685
NZOZ Nasz Lekarz /ID# 143004
Toruń, Kujawsko-pomorskie, Poland, 87-100
REUMED Sp.z o.o. Filia nr 1 /ID# 148189
Lublin, Lubelskie, Poland, 20-607
Malopolskie Centrum Kliniczne /ID# 152782
Cracow, Malopolskie, Poland, 30-149
Pratia MCM Krakow /ID# 143005
Krakow, Malopolskie, Poland, 30-510
McBk Sc /Id# 143003
Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960
Warszawa, Mazowieckie, Poland, 02-507
Centrum Medyczne AMED Warszawa Targowek /ID# 157621
Warszawa, Mazowieckie, Poland, 03-291
Osteo-Medic spolka cywilna /ID# 143006
Białystok, Podlaskie, Poland, 15-351
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293
Gdynia, Pomorskie, Poland, 81-384
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294
Gdynia, Pomorskie, Poland, 81-384
Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295
Gdynia, Pomorskie, Poland, 81-384
Silmedic Sp z o.o /ID# 152914
Katowice, Slaskie, Poland, 40-282
ClinicMed Badurski i wspolnicy SJ /ID# 163300
Bialystok, Poland, 15-879
Solumed Sp. zoo Cent Medyczne /ID# 152783
Poznan, Poland, 60-425
Rheuma Medicus /ID# 143007
Warsaw, Poland, 02-118
Portugal
Instituto Portugues De Reumatologia /ID# 148316
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar De Vila Nova /ID# 143010
Vila Nova De Gaia, Porto, Portugal, 4434-502
CCA Braga - Hospital de Braga /ID# 148317
Braga, Portugal, 4710-243
Hospital CUF Descobertas /ID# 160539
Lisbon, Portugal, 1998-018
Centro Hospitalar de Sao Joao, EPE /ID# 152871
Porto, Portugal, 4200-319
Unidade Local De Saude Do Alto Minho /ID# 143009
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Ponce School of Medicine /ID# 151961
Ponce, Puerto Rico, 00716
GCM Medical Group /ID# 143011
San Juan, Puerto Rico, 00909
Romania
Spitalul Clinic Dr. I. Cantacuzino /ID# 143012
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Dr. I. Cantacuzino /ID# 143017
Bucharest, Bucuresti, Romania, 020475
Spitalul Clinic Sf. Maria /ID# 144868
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 144869
Bucuresti, Romania, 011172
Spitalul Clinic Sf. Maria /ID# 145966
Bucuresti, Romania, 011172
Spitalul Clinic de Recuperare /ID# 144867
Iasi, Romania, 700656
Ecomed SRL /ID# 144870
Oradea, Romania, 410028
Russian Federation
Family Outpatient clinic#4,LLC /ID# 148319
Korolev, Moskva, Russian Federation, 141060
Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138
Moscow, Moskva, Russian Federation, 119049
Perm Clinical Center of FMBA /ID# 145627
Perm, Permskiy Kray, Russian Federation, 614109
LLC Novaya Klinika /ID# 143019
Pyatigorsk, Stavropol Skiy Kray, Russian Federation, 357500
Kazan State Medical University /ID# 144871
Kazan, Tatarstan, Respublika, Russian Federation, 420012
Tver Regional Clinical Hosp. /ID# 143026
Tver, Tverskaya Oblast, Russian Federation, 170036
Сity Clinical Hospital #4 /ID# 143023
Ivanovo, Russian Federation, 153005
Russian National Research Medi /ID# 143028
Moscow, Russian Federation, 117997
City Clinical Hospital Botkina /ID# 145628
Moscow, Russian Federation, 125284
Moscow State Univ Med and Dent /ID# 145623
Moscow, Russian Federation, 127473
City Clinical Hospital #5 /ID# 148318
Nizhnij Novgorod, Russian Federation, 603005
Orenburg State Medical Academy /ID# 143018
Orenburg, Russian Federation, 460000
Ryazan State Medical Universit /ID# 143031
Ryazan, Russian Federation, 390026
II Dzhan Research Center /ID# 143027
St. Petersburg, Russian Federation, 192242
NW State Med Univ NA Mechnikov /ID# 143022
St. Petersburg, Russian Federation, 193015
Republican clinical hospital n /ID# 145626
UFA, Russian Federation, 450005
Ulyanovsk Regional Clin Hosp /ID# 143030
Ulyanovsk, Russian Federation, 432018
Serbia
Institute for Rheumatology /ID# 143032
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143035
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143036
Belgrade, Beograd, Serbia, 11000
Institute for Rheumatology /ID# 143037
Belgrade, Beograd, Serbia, 11000
Special Hospital for Rheuma /ID# 143034
Novi Sad, Vojvodina, Serbia, 21101
Clinical Center of Vojvodina /ID# 143033
Novi Sad, Vojvodina, Serbia, 21137
Slovakia
MEDMAN s.r.o. /ID# 143045
Martin, Slovakia, 036 01
Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169
Nové Mesto Nad Váhom, Slovakia, 915 01
REUMACENTRUM s.r.o. /ID# 143041
Partizanske, Slovakia, 958 01
Slovak research center Team Member, Thermium s.r.o. /ID# 147614
Pieštany, Slovakia, 921 01
Reumex, s.r.o. /ID# 143043
Rimavska Sobota, Slovakia, 97 101
Reumatologicka ambulancia /ID# 144873
Sabinov, Slovakia, 083 01
TIMMED spol. s r.o. /ID# 144872
Stará Lubovna, Slovakia, 06401
Reumatologicka ambulancia, LER /ID# 143044
Topolcany, Slovakia, 955 01
ALBAMED s.r.o. /ID# 143042
Zvolen, Slovakia, 960 01
South Africa
Greenacres Hospital /ID# 144710
Port Elizabeth, Eastern Cape, South Africa, 6045
Wits Clinical Research Site /ID# 148320
Johannesburg, Gauteng, South Africa, 2193
University of Pretoria /ID# 148353
Pretoria, Gauteng, South Africa, 0001
Jakaranda Hosp, Emmed Research /ID# 143046
Pretoria, Gauteng, South Africa, 0132
Jakaranda Hosp, Emmed Research /ID# 145968
Pretoria, Gauteng, South Africa, 0132
St. Augustine's Hospital /ID# 143047
Durban, Kwazulu-Natal, South Africa, 4001
Synexus Helderberg Clinical Tr /ID# 148322
Cape Town, Western Cape, South Africa, 7130
Arthritis Clinical Research Tr /ID# 144874
Cape Town, Western Cape, South Africa, 7405
Tiervlei Trial Centre /ID# 153085
Cape Town, Western Cape, South Africa, 7530
Winelands Medical Research Ctr /ID# 143048
Stellenbosch, Western Cape, South Africa, 7600
Spain
H. Un. Marques de Valdecilla /ID# 143050
Santander, Cantabria, Spain, 39008
Comple Hosp Univ de A Coruna /ID# 143051
A Coruna, Spain, 15006
Hospital Universitario Reina S /ID# 153566
Cordoba, Spain, 14004
Clinica Gaias /ID# 143052
Santiago de Compostela, Spain, 15702
Complejo Hosp Santiago /ID# 153727
Santiago de Compostela, Spain, 15706
Taiwan
China Medical University Hosp /ID# 143058
Taichung City, Taichung, Taiwan, 40447
National Taiwan Univ Hosp /ID# 143056
Taipei City, Taipei, Taiwan, 10002
Kaohsiung Medical University /ID# 143059
Kaohsiung, Taiwan, 80708
Kaohsiung Chang Gung Memorial Hospital /ID# 143055
Kaohsiung, Taiwan, 833
Far Eastern Memorial Hospital /ID# 143061
New Taipei City, Taiwan, 22060
Chung Shan Medical University /ID# 143060
Taichung City, Taiwan, 40201
Taipei Veterans General Hosp /ID# 157940
Taipei City, Taiwan, 11217
Linkou Chang Gung Memorial Ho /ID# 143057
Taoyuan City, Taiwan, 33305
Turkey
Istanbul Universitesi Cerrahpa /ID# 156088
Cerrahpasa, Turkey, 34098
Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063
Istanbul, Turkey, 34147
Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062
Izmir, Turkey, 35360
Ukraine
LLC Revmocentr /ID# 143067
Kiev, Kyiv, Ukraine, 04070
Lviv Regional Clinical Hospita /ID# 154450
Lviv, Lvivska Oblast, Ukraine, 79013
Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071
Vinnytsia, Vinnytska Oblast, Ukraine, 21018
Regional Clinical Hospital /ID# 152025
Ivano-frankivsk, Ukraine, 76018
NSC-Strazhesko Ist Cardiology /ID# 152030
Kiev, Ukraine, 03680
Lviv Municipal City Clinical /ID# 143068
Lviv, Ukraine, 79007
Odessa National Medical Univ /ID# 143072
Odesa, Ukraine, 65026
Zaporizhzhia Regional Clinical /ID# 143069
Zaporizhia, Ukraine, 69600
United Kingdom
The Royal Free Hospital /ID# 143074
London, London, City Of, United Kingdom, NW3 2QG
Queen Alexandra Hospital /ID# 143077
Portsmouth, United Kingdom, PO6 3LY
Warrington + Halton Hosp NHS /ID# 143075
Warrington, United Kingdom, WA5 1LZ
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] December 1, 2017
Statistical Analysis Plan  [PDF] December 7, 2017


Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02629159     History of Changes
Other Study ID Numbers: M14-465
2015-003333-95 ( EudraCT Number )
First Posted: December 14, 2015    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Musculoskeletal disease
Arthritis
Joint disease
Anti-inflammatory agents
Antirheumatic agents
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Methotrexate
Upadacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors