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
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
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).
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03104374 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AbbVie |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
AbbVie Inc. |
Principal Investigator Affiliation | AbbVie |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Belgium, Brazil, Canada, Chile, Czechia, France, Greece, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Portugal, Puerto Rico, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Psoriatic Arthritis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Alabama Medical Group, PC /ID# 159836
Mobile, Alabama, 36608
Status
Recruiting
Address
AZ Arthritis & Rheum Research /ID# 160047
Mesa, Arizona, 85202
Status
Recruiting
Address
SunValley Arthritis Center, Lt /ID# 161203
Peoria, Arizona, 85381
Status
Recruiting
Address
AZ Arthritis and Rheum Researc /ID# 160006
Phoenix, Arizona, 85032-9306
Status
Completed
Address
Osteoporosis Medical Center /ID# 161411
Beverly Hills, California, 90211
Status
Recruiting
Address
Covina Arthritis Clinic /ID# 159919
Covina, California, 91722
Status
Recruiting
Address
TriWest Research Associates /ID# 159915
El Cajon, California, 92020
Status
Recruiting
Address
Saint Jude Heritage /ID# 160005
Fullerton, California, 92835
Status
Recruiting
Address
C.V. Mehta MD, Med Corporation /ID# 161192
Hemet, California, 92543
Status
Recruiting
Address
Care Access Research, Huntingt /ID# 160049
Huntington Beach, California, 92648
Status
Recruiting
Address
Kotha and Kotha /ID# 159834
La Mesa, California, 91942
Status
Recruiting
Address
Stanford Univ School of Med /ID# 161402
Stanford, California, 94305-2200
Status
Recruiting
Address
Inland Rheum Clin Trials Inc. /ID# 159839
Upland, California, 91786
Status
Recruiting
Address
Medvin Clinical Research /ID# 160045
Whittier, California, 90606
Status
Recruiting
Address
Denver Arthritis Clinic /ID# 159899
Denver, Colorado, 80230
Status
Recruiting
Address
Colorado Arthritis Associates /ID# 159856
Lakewood, Colorado, 80228
Status
Recruiting
Address
AARDS Research, Inc. /ID# 161409
Aventura, Florida, 33180
Status
Recruiting
Address
Clinical Res of West FL, Inc. /ID# 159840
Clearwater, Florida, 33765
Status
Recruiting
Address
International Medical Research /ID# 160051
Daytona Beach, Florida, 32117
Status
Recruiting
Address
Precision Research Org, LLC /ID# 161293
Miami Lakes, Florida, 33016-1501
Status
Recruiting
Address
Suncoast Clinical Research /ID# 161417
New Port Richey, Florida, 34652
Status
Recruiting
Address
Millennium Research /ID# 159833
Ormond Beach, Florida, 32174
Status
Recruiting
Address
Arthritis Center, Inc. /ID# 163463
Palm Harbor, Florida, 34684
Status
Recruiting
Address
Gulf Region Clinical Res Inst /ID# 159860
Pensacola, Florida, 32514
Status
Recruiting
Address
St. Anthony Comprehsve Res Ins /ID# 161405
Saint Petersburg, Florida, 33705
Status
Completed
Address
Sarasota Arthritis Center /ID# 159854
Sarasota, Florida, 34239
Status
Recruiting
Address
W. Broward Rheum Assoc Inc. /ID# 161412
Tamarac, Florida, 33321
Status
Recruiting
Address
Clinical Research West FL /ID# 160069
Tampa, Florida, 33603
Status
Recruiting
Address
USF Health Morsani Center for /ID# 161291
Tampa, Florida, 33612
Status
Recruiting
Address
BayCare Medical Group, Inc. /ID# 159912
Tampa, Florida, 33614-7101
Status
Recruiting
Address
FL Med Clinic, PA /ID# 160013
Zephyrhills, Florida, 33542
Status
Recruiting
Address
Jefrey D. Lieberman, MD, P.C. /ID# 159842
Decatur, Georgia, 30033
Status
Recruiting
Address
Marietta Rheumatology Assoc /ID# 161201
Marietta, Georgia, 30060
Status
Completed
Address
Advanced Clinical Research /ID# 159922
Meridian, Idaho, 83642
Status
Recruiting
Address
Great Lakes Clinical Trials /ID# 163438
Chicago, Illinois, 60640
Status
Recruiting
Address
Clinical Investigation Special /ID# 160068
Skokie, Illinois, 60076
Status
Recruiting
Address
Deerbrook Medical Associates /ID# 159815
Vernon Hills, Illinois, 60061
Status
Recruiting
Address
The Arthritis & Diabetes Clinic, Inc. /ID# 161294
Monroe, Louisiana, 71203
Status
Completed
Address
Arthritis Treatment Center /ID# 160053
Frederick, Maryland, 21204
Status
Recruiting
Address
The Center for Rheumatology & /ID# 159900
Wheaton, Maryland, 20902
Status
Recruiting
Address
Clinical Pharma Study Group /ID# 158712
Worcester, Massachusetts, 01610
Status
Recruiting
Address
Clinvest Research LLC /ID# 161208
Springfield, Missouri, 65810-2607
Status
Recruiting
Address
Westroads Clinical Research /ID# 160004
Omaha, Nebraska, 68114
Status
Completed
Address
Atlantic Coast Research /ID# 159810
Toms River, New Jersey, 08755
Status
Recruiting
Address
Arthritis and Osteo Assoc /ID# 160015
Las Cruces, New Mexico, 88011
Status
Recruiting
Address
The Center for Rheumatology /ID# 167046
Albany, New York, 12206
Status
Recruiting
Address
St. Lawrence Health System /ID# 159857
Potsdam, New York, 13676
Status
Recruiting
Address
DJL Clinical Research, PLLC /ID# 161414
Charlotte, North Carolina, 28210-8508
Status
Completed
Address
Physicians East, PA /ID# 159898
Greenville, North Carolina, 27834
Status
Completed
Address
Shanahan Rheuma & Immuno /ID# 160012
Raleigh, North Carolina, 27617
Status
Recruiting
Address
PMG Research of Wilmington LLC /ID# 161403
Wilmington, North Carolina, 28401
Status
Recruiting
Address
Trinity Health Med Arts Clinic /ID# 159811
Minot, North Dakota, 58701
Status
Recruiting
Address
STAT Research, Inc. /ID# 161416
Dayton, Ohio, 45417-3445
Status
Recruiting
Address
Health Research Oklahoma /ID# 159913
Oklahoma City, Oklahoma, 73103-2400
Status
Recruiting
Address
Altoona Ctr Clinical Res /ID# 159861
Duncansville, Pennsylvania, 16635
Status
Completed
Address
University of Pittsburgh MC /ID# 161193
Pittsburgh, Pennsylvania, 15260
Status
Recruiting
Address
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
Summerville, South Carolina, 29486-7887
Status
Recruiting
Address
Rheumatology Consultants, PLLC /ID# 161408
Knoxville, Tennessee, 37909
Status
Recruiting
Address
Dr. Ramesh Gupta /ID# 160067
Memphis, Tennessee, 38119
Status
Recruiting
Address
Tekton Research, Inc. /ID# 160008
Austin, Texas, 78745
Status
Recruiting
Address
Diagnostic Group Integrated He /ID# 161406
Beaumont, Texas, 77701
Status
Completed
Address
Arth and Osteo Clin Brazo Valley /ID# 163439
College Station, Texas, 77845
Status
Recruiting
Address
Adriana Pop-Moody MD Clinic PA /ID# 160009
Corpus Christi, Texas, 78404
Status
Recruiting
Address
Metroplex Clinical Research /ID# 159818
Dallas, Texas, 75231
Status
Completed
Address
Rheumatic Disease Clin Res Ctr /ID# 161252
Houston, Texas, 77004
Status
Recruiting
Address
Accurate Clinical Research /ID# 160052
Houston, Texas, 77034
Status
Recruiting
Address
P&I Clinical Research /ID# 159837
Lufkin, Texas, 75904-3132
Status
Recruiting
Address
SW Rheumatology Res. LLC /ID# 160014
Mesquite, Texas, 75150
Status
Recruiting
Address
DM Clinical Research /ID# 161753
Tomball, Texas, 77375
Status
Recruiting
Address
Arthritis & Osteoporosis Clinic /ID# 161400
Waco, Texas, 76710
Status
Completed
Address
Arthritis Clinic of N. VA, P.C /ID# 159858
Arlington, Virginia, 22205
Status
Recruiting
Address
Swedish Medical Center /ID# 159918
Seattle, Washington, 98104
International Sites
Status
Recruiting
Address
Comple Hosp Univ de A Coruna /ID# 161019
A Coruna, , 15006
Status
Recruiting
Address
Hospital Universitario Reina S /ID# 170764
Cordoba, , 14004
Status
Completed
Address
Optimus Clinical Research Pty. /ID# 166751
Kogarah, New South Wales, 2217
Status
Completed
Address
The Queen Elizabeth Hospital /ID# 200840
Woodville, South Australia, 5011
Status
Completed
Address
Heidelberg Repatriation Hospital /ID# 167441
Heidelberg West, Victoria, 3081
Status
Completed
Address
Box Hill Hospital /ID# 166752
Melbourne, Victoria, 3128
Status
Recruiting
Address
UZ Gent /ID# 164210
Gent, Oost-Vlaanderen, 9000
Status
Recruiting
Address
Reuma clinic /ID# 164214
Genk, , 3600
Status
Recruiting
Address
CIP - Centro Internacional de Pesquisa /ID# 161808
Goiânia, Goias, 74110-120
Status
Recruiting
Address
Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
Uberlândia, Minas Gerais, 38400-902
Status
Recruiting
Address
Hospital de Clinicas de Porto Alegre /ID# 161795
Porto Alegre, Rio Grande Do Sul, 90035-903
Status
Recruiting
Address
LMK Sevicos Medicos S/S /ID# 161806
Porto Alegre, Rio Grande Do Sul, 90480-000
Status
Recruiting
Address
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163317
Ribeirao Preto, Sao Paulo, 14049-900
Status
Recruiting
Address
Faculdade de Medicina do ABC /ID# 163489
Santo André, Sao Paulo, 09060-870
Status
Recruiting
Address
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 161793
São Paulo, Sao Paulo, 05403-000
Status
Recruiting
Address
Percuro Clinical Research, Ltd /ID# 157835
Victoria, British Columbia, V8V 3M9
Status
Recruiting
Address
Ciads /Id# 157843
Winnipeg, Manitoba, R3N 0K6
Status
Recruiting
Address
The Waterside Clinic /ID# 157838
Barrie, Ontario, L4M 6L2
Status
Recruiting
Address
Groupe de Recherche en Maladies Osseuses /ID# 157836
Sainte-foy, Quebec, G1V 3M7
Status
Recruiting
Address
Ctr. de Recherche Musculo-Sque /ID# 163557
Trois-rivières, Quebec, G8Z 1Y2
Status
Not yet recruiting
Address
M y F Estudios Clínicos Ltda. /ID# 169539
Ñuñoa, Region Metropolitana De Santiago, 7750495
Status
Recruiting
Address
CTR Estudios SpA /ID# 206038
Providencia, , 7500571
Status
Recruiting
Address
Centro Inter Estud Clin CIEC /ID# 169543
Santiago, , 8420383
Status
Recruiting
Address
Prosalud Ltda. /ID# 169542
Santiago, , ZC:7510047
Status
Recruiting
Address
Clínica Dermacross S.A /ID# 169537
Vitacura, Santiago, , 7640881
Status
Recruiting
Address
Revmatologie Bruntal, s.r.o /ID# 159632
Bruntál, , 79201
Status
Recruiting
Address
Medical Plus, s.r.o. /ID# 159631
Uherské Hradište, , 686 01
Status
Recruiting
Address
Hopital Saint Joseph /ID# 163755
Marseille CEDEX 08, Bouches-du-Rhone, 13285
Status
Recruiting
Address
Hopital Universitaire Purpan /ID# 163743
Toulouse, Haute-Garonne, 31059
Status
Recruiting
Address
Centre Hospitalier Le Mans /ID# 163746
Le Mans CEDEX 9, Sarthe, 72037
Status
Recruiting
Address
CHU-Hospital Henri Mondor /ID# 163895
Creteil, , 94010
Status
Recruiting
Address
Hopital Lariboisiere /ID# 163773
Paris, , 75010
Status
Recruiting
Address
Hopital Trousseau /ID# 163772
Tours, , 37044
Status
Recruiting
Address
General Hospital of Athens Laiko /ID# 163474
Athens, Attiki, 115 27
Status
Recruiting
Address
Naval Hospital of Athens /ID# 163495
Athens, , 11521
Status
Recruiting
Address
Reg Gen Univ Hosp Larissa /ID# 163493
Larisa, , 41110
Status
Recruiting
Address
Vital Medical Center Orvosi es /ID# 162571
Veszprém, Veszprem, 8200
Status
Recruiting
Address
Betegapolo Irgalmas Rend - Bud /ID# 170911
Budapest, , 1023
Status
Recruiting
Address
Revita Reumatologiai Rendelo /ID# 162575
Budapest, , 1027
Status
Completed
Address
Obudai Egeszsegugyi Centrum Kft. /ID# 162576
Budapest, , 1036
Status
Recruiting
Address
Debreceni Egyetem Kenezy Gyula /ID# 162572
Debrecen, , 4031
Status
Completed
Address
Petz Aladar Megyei Oktato Kor /ID# 162573
Gyor, , 9023
Status
Recruiting
Address
MAV Korhaz ess Rendelointezet /ID# 162574
Szolnok, , 5000
Status
Recruiting
Address
AOU Federico II /ID# 202410
Naples, Campania, 80131
Status
Recruiting
Address
Azienda Unità Sanitaria Locale/IRCCS c/o "Arcispedale Santa Maria Nuova" /ID# 162751
Reggio Emilia, Emilia-Romagna, 42123
Status
Recruiting
Address
Policlinico Universitario Campus Bio-Medico /ID# 164123
Rome, Lazio, 00128
Status
Recruiting
Address
A.O. Univ. Ospedali Riuniti /ID# 162748
Ancona, Marche, 60126
Status
Recruiting
Address
Fondazione PTV Policlinico Tor Vergata /ID# 162749
Rome, Roma, 00133
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 164126
Catania, , 95123
Status
Recruiting
Address
AOU Arcispedale Sant Anna di /ID# 164127
Cona, , 44124
Status
Recruiting
Address
ASST G. Pini /ID# 164125
Milan, , 20122
Status
Recruiting
Address
Nagoya City University Hospital /ID# 162563
Nagoya-shi, Aichi, 467-8602
Status
Recruiting
Address
Fukuoka University Hospital /ID# 161774
Fukuoka-shi, Fukuoka, 814-0180
Status
Recruiting
Address
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center /ID# 163516
Kitakyushu-shi, Fukuoka, 802-0077
Status
Recruiting
Address
Asahikawa Medical University Hospital /ID# 200684
Asahikawa-shi, Hokkaido, 078-8510
Status
Recruiting
Address
Mie University Hospital /ID# 162085
Tsu-shi, Mie, 514-8507
Status
Recruiting
Address
Tohoku University Hospital /ID# 164035
Sendai-shi, Miyagi, 980-8574
Status
Recruiting
Address
Oribe Clinic of Rheumatism and Medicine /ID# 163704
Oita-shi, Oita, 870-0823
Status
Recruiting
Address
Kansai Medical University Hospital /ID# 162081
Hirakata-shi, Osaka, 573-1191
Status
Recruiting
Address
NHO Osaka Minami Med Ctr /ID# 162589
Kawachinagano-shi, Osaka, 586-8521
Status
Recruiting
Address
Osaka City University Hospital /ID# 162082
Osaka-shi, Osaka, 545-0051
Status
Recruiting
Address
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
Osaka-shi, Osaka, 550-0006
Status
Recruiting
Address
St.Luke's International Hospital /ID# 162013
Chuo-ku, Tokyo, 104-8560
Status
Recruiting
Address
Keio University Hospital /ID# 162130
Shinjuku-ku, Tokyo, 160-8582
Status
Completed
Address
Hopsital of the University of Occupational and Enviromental Health /ID# 161472
Fukuoka, , 8078556
Status
Recruiting
Address
Daido Hospital /ID# 163639
Nagoya, , 457-8511
Status
Recruiting
Address
Juntendo University Hospital /ID# 162089
Tokyo, , 113-8431
Status
Completed
Address
Ajou University Hospital /ID# 163893
Suwon-si, Gyeonggido, 16499
Status
Completed
Address
Inha University Hospital /ID# 163892
Jung-gu, Incheon Gwang Yeogsi, 22332
Status
Completed
Address
Medisch Centrum Leeuwarden /ID# 163049
Leeuwarden, , 8934 AD
Status
Completed
Address
Sint Maartenskliniek /ID# 163703
Nijmegen, , 6522 JV
Status
Recruiting
Address
Erasmus Medisch Centrum /ID# 163052
Rotterdam, , 3015 CE
Status
Completed
Address
Maasstad Ziekenhuis /ID# 163050
Rotterdam, , 3079 DZ
Status
Recruiting
Address
Waikato Hospital /ID# 166412
Hamilton, Waikato, 3204
Status
Recruiting
Address
Middlemore Hospital /ID# 166411
Auckland, , 2025
Status
Recruiting
Address
Porter Rheumatology Ltd /ID# 200422
Nelson, , 7010
Status
Recruiting
Address
Timaru Rheumatology Studies /ID# 166410
Timaru, , 7910
Status
Recruiting
Address
Instituto Portugues De Reumatologia /ID# 165894
Lisbon, Lisboa, 1050-034
Status
Recruiting
Address
Centro Hospitalar Lisboa Ocidental, EPE /ID# 165896
Lisbon, Lisboa, 1349-019
Status
Recruiting
Address
Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165897
Vila Nova De Gaia, Porto, 4434-502
Status
Recruiting
Address
Centro Hospitalar Lisboa Norte, EPE /ID# 165895
Lisboa, , 1649-035
Status
Recruiting
Address
Unidade Local De Saude Do Alto Minho /ID# 165898
Viana Do Castelo, , 4901-858
Status
Completed
Address
Cruz-Santana, Carolina, PR /ID# 163308
Carolina, , 00985
Status
Recruiting
Address
Ponce School of Medicine /ID# 163918
Ponce, , 00716
Status
Recruiting
Address
GCM Medical Group /ID# 163716
San Juan, , 00909
Status
Recruiting
Address
Hospital Virgen de La Arrixaca /ID# 163138
El Palmar, , 30120
Status
Completed
Address
Hospital Universitario Campus /ID# 170768
Granada, , 18014
Status
Completed
Address
Hospital Univ Ramon y Cajal /ID# 161020
Madrid, , 28034
Status
Completed
Address
Royal United Hospitals Bath /ID# 161054
Bath, Bath And North East Somerset, BA1 1RL
Status
Recruiting
Address
Whipps Cross Univ Hospital /ID# 161053
London, London, City Of, E11 1NR
Status
Recruiting
Address
Guy's and St Thomas' NHS Found /ID# 161063
London, London, City Of, SE1 9RT
Status
Recruiting
Address
Christchurch Hospital /ID# 162711
Christchurch, , BH23 2JX
Status
Recruiting
Address
Glasgow Royal Infirmary /ID# 162712
Glasgow, , G4 0SF
Status
Recruiting
Address
Luton & Dunstable University Hospital /ID# 162713
Luton, , LU4 0DZ