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A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 2)

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. Identifier: NCT03104374
Recruitment Status : Active, not recruiting
First Posted : April 7, 2017
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Placebo Drug: ABT-494 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 642 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 in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : July 17, 2019
Estimated Study Completion Date : April 22, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ABT-494 Dose A
It is administered once daily.
Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Placebo Comparator: Placebo followed by ABT-494 Dose B
It is administered once daily.
Drug: Placebo
Oral tablet

Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Experimental: ABT-494 Dose B
It is administered once daily.
Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Placebo Comparator: Placebo followed by ABT-494 Dose A
It is administered once daily.
Drug: Placebo
Oral tablet

Drug: ABT-494
Oral tablet
Other Name: Upadacitinib

Primary Outcome Measures :
  1. Proportion of participants achieving American College of Rheumatology (ACR) 20 response [ Time Frame: Week 12 ]
    Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high sensitivity C-reactive protein (hsCRP).

Secondary Outcome Measures :
  1. ACR 50 response [ Time Frame: Week 12 ]
    Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high sensitivity C-reactive protein (hsCRP).

  2. Proportion of participants achieving a static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline [ Time Frame: Week 16 ]
    The sIGA is a 5 point score ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit.

  3. Psoriasis Area Severity Index (PASI) 75 response (for participants with >= 3% BSA psoriasis at baseline) [ Time Frame: Week 16 ]
    The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 16. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.

  4. Proportion of participants achieving Minimal Disease Activity (MDA) [ Time Frame: Week 24 ]
    The proportion of subjects achieving MDA will be determined based on subjects fulfilling 5 of 7 outcome measures: TJC <= 1; SJC <= 1; PASI <=1 or BSA-Ps <= 3%; Patient's Assessment of Pain NRS <= 1.5; PtGA-Disease Activity NRS <= 2.0; HAQ-DI score <= 0.5; and tender entheseal points <= 1.

  5. Change from baseline in HAQ-DI [ Time Frame: Week 12 ]
    The HAQ DI is a patient-reported questionnaire. It includes the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. It asks patients about the amount of difficulty they experience in these activities as well as the use of aids and/or devices.

  6. ACR 70 response [ Time Frame: Week 12 ]
    Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high sensitivity C-reactive protein (hsCRP).

  7. ACR 20 response [ Time Frame: Week 2 ]
    Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PhGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high sensitivity C-reactive protein (hsCRP).

  8. Change from baseline in Short-Form (SF)-36 Physical Component Summary (PCS) [ Time Frame: Week 12 ]
    The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores are aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).

  9. Change from baseline in FACIT-Fatigue Questionnaire [ Time Frame: Week 12 ]
    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue.

  10. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire [ Time Frame: Week 16 ]
    The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain.

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.

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

Inclusion Criteria:

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
  • Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
  • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

  • Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
  • Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

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 identifier (NCT number): NCT03104374

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United States, Alabama
Alabama Medical Group, PC /ID# 159836
Mobile, Alabama, United States, 36608-1787
United States, Arizona
AZ Arthritis & Rheum Research /ID# 160047
Mesa, Arizona, United States, 85202
SunValley Arthritis Center, Lt /ID# 161203
Peoria, Arizona, United States, 85381
AZ Arthritis and Rheum Researc /ID# 160006
Phoenix, Arizona, United States, 85032-9306
United States, California
Osteoporosis Medical Center /ID# 161411
Beverly Hills, California, United States, 90211
Covina Arthritis Clinic /ID# 159919
Covina, California, United States, 91722
TriWest Research Associates /ID# 159915
El Cajon, California, United States, 92020
Saint Jude Heritage /ID# 160005
Fullerton, California, United States, 92835
C.V. Mehta MD, Med Corporation /ID# 161192
Hemet, California, United States, 92543
Care Access Research, Huntingt /ID# 160049
Huntington Beach, California, United States, 92648
Kotha and Kotha /ID# 159834
La Mesa, California, United States, 91942
Stanford Univ School of Med /ID# 161402
Stanford, California, United States, 94305-2200
Inland Rheum Clin Trials Inc. /ID# 159839
Upland, California, United States, 91786
Medvin Clinical Research /ID# 160045
Whittier, California, United States, 90606
United States, Colorado
Denver Arthritis Clinic /ID# 159899
Denver, Colorado, United States, 80230
Colorado Arthritis Associates /ID# 159856
Lakewood, Colorado, United States, 80228
United States, Florida
AARDS Research, Inc. /ID# 161409
Aventura, Florida, United States, 33180
Clinical Res of West FL, Inc. /ID# 159840
Clearwater, Florida, United States, 33765
International Medical Research - Daytona /ID# 160051
Daytona Beach, Florida, United States, 32117
Precision Research Org, LLC /ID# 161293
Miami Lakes, Florida, United States, 33016-1501
Suncoast Clinical Research /ID# 161417
New Port Richey, Florida, United States, 34652
Millennium Research /ID# 159833
Ormond Beach, Florida, United States, 32174
Arthritis Center, Inc. /ID# 163463
Palm Harbor, Florida, United States, 34684
Gulf Region Clinical Res Inst /ID# 159860
Pensacola, Florida, United States, 32514
St. Anthony Comprehsve Res Ins /ID# 161405
Saint Petersburg, Florida, United States, 33705
Sarasota Arthritis Center /ID# 159854
Sarasota, Florida, United States, 34239
W. Broward Rheum Assoc Inc. /ID# 161412
Tamarac, Florida, United States, 33321
Clinical Research West FL /ID# 160069
Tampa, Florida, United States, 33603
USF Health Morsani Center for /ID# 161291
Tampa, Florida, United States, 33612
BayCare Medical Group, Inc. /ID# 159912
Tampa, Florida, United States, 33614-7101
FL Med Clinic, PA /ID# 160013
Zephyrhills, Florida, United States, 33542
United States, Georgia
Jefrey D. Lieberman, MD, P.C. /ID# 159842
Decatur, Georgia, United States, 30033
Marietta Rheumatology Assoc /ID# 161201
Marietta, Georgia, United States, 30060
United States, Idaho
Advanced Clinical Research /ID# 159922
Meridian, Idaho, United States, 83642
United States, Illinois
Great Lakes Clinical Trials /ID# 163438
Chicago, Illinois, United States, 60640
Clinical Investigation Special /ID# 160068
Skokie, Illinois, United States, 60076
Deerbrook Medical Associates /ID# 159815
Vernon Hills, Illinois, United States, 60061
United States, Louisiana
The Arthritis & Diabetes Clinic, Inc. /ID# 161294
Monroe, Louisiana, United States, 71203
United States, Maryland
Arthritis Treatment Center /ID# 160053
Frederick, Maryland, United States, 21204
The Center for Rheumatology & /ID# 159900
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Clinical Pharma Study Group /ID# 158712
Worcester, Massachusetts, United States, 01610
United States, Missouri
Clinvest Research LLC /ID# 161208
Springfield, Missouri, United States, 65810-2607
United States, Nebraska
Westroads Clinical Research /ID# 160004
Omaha, Nebraska, United States, 68114
United States, New Jersey
Atlantic Coast Research /ID# 159810
Toms River, New Jersey, United States, 08755
United States, New Mexico
Arthritis and Osteo Assoc /ID# 160015
Las Cruces, New Mexico, United States, 88011
United States, New York
The Center for Rheumatology /ID# 167046
Albany, New York, United States, 12206
St. Lawrence Health System /ID# 159857
Potsdam, New York, United States, 13676
United States, North Carolina
DJL Clinical Research, PLLC /ID# 161414
Charlotte, North Carolina, United States, 28210-8508
Physicians East, PA /ID# 159898
Greenville, North Carolina, United States, 27834
Shanahan Rheuma & Immuno /ID# 160012
Raleigh, North Carolina, United States, 27617
PMG Research of Wilmington LLC /ID# 161403
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Trinity Health Med Arts Clinic /ID# 159811
Minot, North Dakota, United States, 58701
United States, Ohio
STAT Research, Inc. /ID# 161416
Dayton, Ohio, United States, 45417-3445
United States, Oklahoma
Health Research Oklahoma /ID# 159913
Oklahoma City, Oklahoma, United States, 73103-2400
United States, Pennsylvania
Altoona Ctr Clinical Res /ID# 159861
Duncansville, Pennsylvania, United States, 16635
University of Pittsburgh MC /ID# 161193
Pittsburgh, Pennsylvania, United States, 15260
United States, South Carolina
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
Summerville, South Carolina, United States, 29486-7887
United States, Tennessee
Rheumatology Consultants, PLLC /ID# 161408
Knoxville, Tennessee, United States, 37909
Dr. Ramesh Gupta /ID# 160067
Memphis, Tennessee, United States, 38119
United States, Texas
Tekton Research, Inc. /ID# 160008
Austin, Texas, United States, 78745
Diagnostic Group Integrated He /ID# 161406
Beaumont, Texas, United States, 77701
Arth and Osteo Clin Brazo Valley /ID# 163439
College Station, Texas, United States, 77845
Adriana Pop-Moody MD Clinic PA /ID# 160009
Corpus Christi, Texas, United States, 78404
Metroplex Clinical Research /ID# 159818
Dallas, Texas, United States, 75231
Rheumatic Disease Clin Res Ctr /ID# 161252
Houston, Texas, United States, 77004
Accurate Clinical Research /ID# 160052
Houston, Texas, United States, 77034
P&I Clinical Research /ID# 159837
Lufkin, Texas, United States, 75904-3132
SW Rheumatology Res. LLC /ID# 160014
Mesquite, Texas, United States, 75150
DM Clinical Research /ID# 161753
Tomball, Texas, United States, 77375
Arthritis & Osteoporosis Clinic /ID# 161400
Waco, Texas, United States, 76710
United States, Virginia
Arthritis Clinic of N. VA, P.C /ID# 159858
Arlington, Virginia, United States, 22205
United States, Washington
Swedish Medical Center /ID# 159918
Seattle, Washington, United States, 98104
Australia, New South Wales
Optimus Clinical Research Pty. /ID# 166751
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
The Queen Elizabeth Hospital /ID# 200840
Woodville, South Australia, Australia, 5011
Australia, Victoria
Heidelberg Repatriation Hospital /ID# 167441
Heidelberg West, Victoria, Australia, 3081
Box Hill Hospital /ID# 166752
Melbourne, Victoria, Australia, 3128
UZ Gent /ID# 164210
Gent, Oost-Vlaanderen, Belgium, 9000
Reuma clinic /ID# 164214
Genk, Belgium, 3600
CIP - Centro Internacional de Pesquisa /ID# 161808
Goiânia, Goias, Brazil, 74110-120
Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
Uberlândia, Minas Gerais, Brazil, 38400-902
Hospital de Clinicas de Porto Alegre /ID# 161795
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
LMK Sevicos Medicos S/S /ID# 161806
Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Faculdade de Medicina do ABC /ID# 163489
Santo André, Sao Paulo, Brazil, 09060-870
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793
São Paulo, Sao Paulo, Brazil, 05403-000
Canada, British Columbia
Percuro Clinical Research, Ltd /ID# 157835
Victoria, British Columbia, Canada, V8V 3M9
Canada, Manitoba
Ciads /Id# 157843
Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Ontario
The Waterside Clinic /ID# 157838
Barrie, Ontario, Canada, L4M 6L2
Canada, Quebec
Groupe de Recherche en Maladies Osseuses /ID# 157836
Sainte-foy, Quebec, Canada, G1V 3M7
Ctr. de Recherche Musculo-Sque /ID# 163557
Trois-rivières, Quebec, Canada, G8Z 1Y2
CTR Estudios SpA /ID# 206038
Providencia, Chile, 7500571
Centro Inter Estud Clin CIEC /ID# 169543
Santiago, Chile, 8420383
Prosalud Ltda. /ID# 169542
Santiago, Chile, ZC:7510047
Clínica Dermacross S.A /ID# 169537
Vitacura, Santiago, Chile, 7640881
Revmatologie Bruntal, s.r.o /ID# 159632
Bruntál, Czechia, 79201
Medical Plus, s.r.o. /ID# 159631
Uherské Hradište, Czechia, 686 01
Hopital Saint Joseph /ID# 163755
Marseille CEDEX 08, Bouches-du-Rhone, France, 13285
Hopital Universitaire Purpan /ID# 163743
Toulouse, Haute-Garonne, France, 31059
Centre Hospitalier Le Mans /ID# 163746
Le Mans CEDEX 9, Sarthe, France, 72037
CHU-Hospital Henri Mondor /ID# 163895
Creteil, France, 94010
Hopital Lariboisiere /ID# 163773
Paris, France, 75010
Hopital Trousseau /ID# 163772
Tours, France, 37044
General Hospital of Athens Laiko /ID# 163474
Athens, Attiki, Greece, 115 27
Naval Hospital of Athens /ID# 163495
Athens, Greece, 11521
Reg Gen Univ Hosp Larissa /ID# 163493
Larisa, Greece, 41110
Vital Medical Center Orvosi es /ID# 162571
Veszprém, Veszprem, Hungary, 8200
Betegapolo Irgalmas Rend - Bud /ID# 170911
Budapest, Hungary, 1023
Revita Reumatologiai Rendelo /ID# 162575
Budapest, Hungary, 1027
Obudai Egeszsegugyi Centrum Kft. /ID# 162576
Budapest, Hungary, 1036
Debreceni Egyetem Kenezy Gyula /ID# 162572
Debrecen, Hungary, 4031
Petz Aladar Megyei Oktato Kor /ID# 162573
Gyor, Hungary, 9023
MAV Korhaz ess Rendelointezet /ID# 162574
Szolnok, Hungary, 5000
AOU Federico II /ID# 202410
Naples, Campania, Italy, 80131
Azienda Unità Sanitaria Locale/IRCCS c/o "Arcispedale Santa Maria Nuova" /ID# 162751
Reggio Emilia, Emilia-Romagna, Italy, 42123
Policlinico Universitario Campus Bio-Medico /ID# 164123
Rome, Lazio, Italy, 00128
A.O. Univ. Ospedali Riuniti /ID# 162748
Ancona, Marche, Italy, 60126
Fondazione PTV Policlinico Tor Vergata /ID# 162749
Rome, Roma, Italy, 00133
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 164126
Catania, Italy, 95123
AOU Arcispedale Sant Anna di /ID# 164127
Cona, Italy, 44124
ASST G. Pini /ID# 164125
Milan, Italy, 20122
Nagoya City University Hospital /ID# 162563
Nagoya-shi, Aichi, Japan, 467-8602
Fukuoka University Hospital /ID# 161774
Fukuoka-shi, Fukuoka, Japan, 814-0180
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center /ID# 163516
Kitakyushu-shi, Fukuoka, Japan, 802-0077
Asahikawa Medical University Hospital /ID# 200684
Asahikawa-shi, Hokkaido, Japan, 078-8510
Mie University Hospital /ID# 162085
Tsu-shi, Mie, Japan, 514-8507
Tohoku University Hospital /ID# 164035
Sendai-shi, Miyagi, Japan, 980-8574
Oribe Clinic of Rheumatism and Medicine /ID# 163704
Oita-shi, Oita, Japan, 870-0823
Kansai Medical University Hospital /ID# 162081
Hirakata-shi, Osaka, Japan, 573-1191
NHO Osaka Minami Med Ctr /ID# 162589
Kawachinagano-shi, Osaka, Japan, 586-8521
Osaka City University Hospital /ID# 162082
Osaka-shi, Osaka, Japan, 545-0051
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
Osaka-shi, Osaka, Japan, 550-0006
Juntendo University Hospital /ID# 162089
Bunkyo-ku, Tokyo, Japan, 113-8431
St.Luke's International Hospital /ID# 162013
Chuo-ku, Tokyo, Japan, 104-8560
Keio University Hospital /ID# 162130
Shinjuku-ku, Tokyo, Japan, 160-8582
Hopsital of the University of Occupational and Enviromental Health /ID# 161472
Fukuoka, Japan, 8078556
Daido Hospital /ID# 163639
Nagoya, Japan, 457-8511
Korea, Republic of
Ajou University Hospital /ID# 163893
Suwon-si, Gyeonggido, Korea, Republic of, 16499
Inha University Hospital /ID# 163892
Jung-gu, Incheon Gwang Yeogsi, Korea, Republic of, 22332
Medisch Centrum Leeuwarden /ID# 163049
Leeuwarden, Netherlands, 8934 AD
Sint Maartenskliniek /ID# 163703
Nijmegen, Netherlands, 6522 JV
Erasmus Medisch Centrum /ID# 163052
Rotterdam, Netherlands, 3015 CE
Maasstad Ziekenhuis /ID# 163050
Rotterdam, Netherlands, 3079 DZ
New Zealand
Waikato Hospital /ID# 166412
Hamilton, Waikato, New Zealand, 3204
Middlemore Hospital /ID# 166411
Auckland, New Zealand, 2025
Porter Rheumatology Ltd /ID# 200422
Nelson, New Zealand, 7010
Timaru Rheumatology Studies /ID# 166410
Timaru, New Zealand, 7910
Instituto Portugues De Reumatologia /ID# 165894
Lisbon, Lisboa, Portugal, 1050-034
Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896
Lisbon, Lisboa, Portugal, 1349-019
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897
Vila Nova De Gaia, Porto, Portugal, 4434-502
Centro Hospitalar Lisboa Norte, EPE /ID# 165895
Lisboa, Portugal, 1649-035
Unidade Local De Saude Do Alto Minho /ID# 165898
Viana Do Castelo, Portugal, 4901-858
Puerto Rico
Cruz-Santana, Carolina, PR /ID# 163308
Carolina, Puerto Rico, 00985
Ponce School of Medicine /ID# 163918
Ponce, Puerto Rico, 00716
GCM Medical Group /ID# 163716
San Juan, Puerto Rico, 00909
Comple Hosp Univ de A Coruna /ID# 161019
A Coruna, Spain, 15006
Hospital Universitario Reina S /ID# 170764
Cordoba, Spain, 14004
Hospital Virgen de La Arrixaca /ID# 163138
El Palmar, Spain, 30120
Hospital Universitario Campus /ID# 170768
Granada, Spain, 18014
Hospital Univ Ramon y Cajal /ID# 161020
Madrid, Spain, 28034
United Kingdom
Royal United Hospitals Bath /ID# 161054
Bath, Bath And North East Somerset, United Kingdom, BA1 1RL
Whipps Cross Univ Hospital /ID# 161053
London, London, City Of, United Kingdom, E11 1NR
Guy's and St Thomas' NHS Found /ID# 161063
London, London, City Of, United Kingdom, SE1 9RT
Christchurch Hospital /ID# 162711
Christchurch, United Kingdom, BH23 2JX
Glasgow Royal Infirmary /ID# 162712
Glasgow, United Kingdom, G4 0SF
Luton & Dunstable University Hospital /ID# 162713
Luton, United Kingdom, LU4 0DZ
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie Identifier: NCT03104374     History of Changes
Other Study ID Numbers: M15-554
2016-004152-30 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 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.

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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:
Joint disease
Musculoskeletal disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Connective Tissue Diseases
Arthritis, Psoriatic
Antirheumatic Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action