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)

August 22, 2025 updated by: AbbVie

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)

This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study included a 35-day screening period; a 56-week blinded period which included 24 weeks of randomized, double-blind, parallel-group, placebo-controlled treatment followed by an additional 32 weeks of treatment blinded to the dose of upadacitinib (Period 1); a long-term extension period of up to a total treatment duration of up to approximately 3 years (Period 2); and a 30-day follow-up call or visit.

All participants in Period 1 who were randomized to receive Placebo up to 24 weeks were pooled for the assessment of all outcome measures. All participants receiving upadacitinib 30 mg QD during Period 2 were switched to upadacitinib 15 mg QD following a protocol amendment and were pooled for AE reporting.

Study Type

Interventional

Enrollment (Actual)

642

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research Sydney /ID# 166751
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital /ID# 200840
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital /ID# 166752
      • Heidelberg West, Victoria, Australia, 3081
        • Heidelberg Repatriation Hospital /ID# 167441
  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • ReumaClinic /ID# 164214
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent /ID# 164210
  • Brazil
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 161793
    • Goiás
      • Goiânia, Goiás, Brazil, 74110-120
        • CIP - Centro Internacional de Pesquisa /ID# 161808
    • La Spezia
      • Santo André, La Spezia, Brazil, 09060-870
        • Faculdade de Medicina do ABC /ID# 163489
    • Minas Gerais
      • Uberlândia, Minas Gerais, Brazil, 38400-902
        • Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre /ID# 161795
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 161806
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Duplicate_Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 163317
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 157835
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • CIADS Research Co Ltd /ID# 157843
    • Ontario
      • Orillia, Ontario, Canada, L3V 1T5
        • The Waterside Clinic /ID# 157838
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses Inc /ID# 157836
      • Trois-Rivières, Quebec, Canada, G8Z 1Y2
        • Centre de Recherche Musculo-Squelettique /ID# 163557
  • Chile
      • Santiago, Chile, ZC:7510047
        • Prosalud Ltda. /ID# 169542
      • Santiago, Chile, 7640881
        • Duplicate_Clinica Dermacross /ID# 169537
      • Santiago, Chile, 8420383
        • Duplicate_Centro Internacional de Estudios Clinicos /ID# 169543
    • Aysén
      • Providencia, Aysén, Chile, 7500571
        • CTR Estudios Clinicos /ID# 206038
  • Czechia
      • Prostějov, Czechia, 796 01
        • Revmatologie Bruntal, s.r.o /ID# 159632
      • Uherské Hradiště, Czechia, 686 01
        • Medical Plus, s.r.o. /ID# 159631
  • France
      • Chambray-lès-Tours, France, 37170
        • CHRU Tours - Hopital Trousseau /ID# 163772
      • Créteil, France, 94010
        • Duplicate_CHU-Hospital Henri Mondor /ID# 163895
      • Paris, France, 75010
        • Duplicate_AP-HP - Hopital Lariboisiere /ID# 163773
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13008
        • Hopital Saint Joseph /ID# 163755
    • Occitanie
      • Toulouse, Occitanie, France, 31300
        • CHU Toulouse /ID# 163743
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier du Mans /ID# 163746
  • Greece
      • Athens, Greece, 11521
        • Naval Hospital of Athens /ID# 163495
      • Larissa, Greece, 41110
        • Reg Gen Univ Hosp Larissa /ID# 163493
    • Attica
      • Athens, Attica, Greece, 11527
        • General Hospital of Athens Laiko /ID# 163474
  • Hungary
      • Budapest, Hungary, 1027
        • Revita Reumatologiai Rendelo /ID# 162575
      • Budapest, Hungary, 1023
        • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 170911
      • Budapest, Hungary, 1036
        • Obudai Egeszsegugyi Centrum Kft. /ID# 162576
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 162572
      • Szolnok, Hungary, 5000
        • MÁV Kórház /ID# 162574
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 162573
    • Veszprém megye
      • Veszprém, Veszprém megye, Hungary, 8200
        • Vital Medicina Kft /ID# 162571
  • Italy
      • Ancona, Italy, 60126
        • Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 162748
      • Catania, Italy, 95123
        • Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 164126
      • Cona, Italy, 44124
        • Duplicate_AOU Arcispedale Sant Anna di /ID# 164127
      • Milan, Italy, 20122
        • ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 164125
      • Reggio Emilia, Italy, 42123
        • Duplicate_Azienda Unita Sanitaria Locale/IRCCS /ID# 162751
    • L Aquila
      • Napoli, L Aquila, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II /ID# 202410
    • Roma
      • Rome, Roma, Italy, 00128
        • Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 164123
      • Rome, Roma, Italy, 00133
        • Duplicate_Fondazione PTV Policlinico Tor Vergata /ID# 162749
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Daido Hospital /ID# 163639
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Nagoya City University Hospital /ID# 162563
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 161774
      • Kitakyushu-shi, Fukuoka, Japan, 802-8561
        • Duplicate_Kitakyushu Municipal Medical Center /ID# 163516
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital /ID# 200684
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital /ID# 162085
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 164035
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-0823
        • Oribe Clinic of Rheumatism and Medicine /ID# 163704
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital /ID# 162081
      • Kawachinagano Shi, Osaka, Japan, 586-8521
        • National Hospital Organization Osaka Minami Medical Center /ID# 162589
      • Osaka, Osaka, Japan, 545-8586
        • Osaka Metropolitan University Hospital /ID# 162082
      • Osaka, Osaka, Japan, 550-0006
        • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 162089
      • Chuo-ku, Tokyo, Japan, 104-8560
        • St.Luke's International Hospital /ID# 162013
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital /ID# 162130
  • Netherlands
      • Ubbergen, Netherlands, 6574 NA
        • Sint Maartenskliniek /ID# 163703
    • South Holland
      • Leeuwarden, South Holland, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 163049
      • Rotterdam, South Holland, Netherlands, 3015 GD
        • Duplicate_Erasmus Medisch Centrum /ID# 163052
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Maasstad Ziekenhuis /ID# 163050
  • New Zealand
      • Nelson, New Zealand, 7010
        • Porter Rheumatology Ltd /ID# 200422
    • Auckland
      • Otahuhu, Auckland, New Zealand, 2025
        • Duplicate_Middlemore Hospital /ID# 166411
    • Canterbury
      • Timaru, Canterbury, New Zealand, 7910
        • Timaru Medical Specialists Ltd /ID# 166410
    • Waikato Region
      • Hamilton, Waikato Region, New Zealand, 3240
        • Waikato Hospital /ID# 166412
  • Portugal
      • Lisbon, Portugal, 1050-034
        • Instituto Portugues De Reumatologia /ID# 165894
      • Lisbon, Portugal, 1349-019
        • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896
      • Lisbon, Portugal, 1649-035
        • Unidade Local de Saude de Santa Maria, EPE /ID# 165895
    • Porto District
      • Vila Nova de Gaia, Porto District, Portugal, 4434-502
        • Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897
    • Viana do Castelo District
      • Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
        • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898
  • Puerto Rico
      • Carolina, Puerto Rico, 00985
        • Alma M. Cruz Santana, MD-Private practice /ID# 163308
      • Ponce, Puerto Rico, 00716-0377
        • Ponce Medical School Foundation /ID# 163918
      • San Juan, Puerto Rico, 00917-3104
        • GCM Medical Group PSC /ID# 163716
  • South Korea
    • Gyeonggido
      • Suwon, Gyeonggido, South Korea, 16499
        • Duplicate_Ajou University Hospital /ID# 163893
    • Incheon Gwang Yeogsi
      • Junggu, Incheon Gwang Yeogsi, South Korea, 22332
        • Duplicate_Inha University Hospital /ID# 163892
  • Spain
      • A Coruña, Spain, 15006
        • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019
      • Córdoba, Spain, 14004
        • Duplicate_Hospital Universitario Reina Sofia /ID# 170764
      • Granada, Spain, 18016
        • Hospital Campus de la Salud /ID# 170768
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal /ID# 161020
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
  • United Kingdom
      • Glasgow, United Kingdom, G12 0XH
        • Duplicate_NHS Greater Glasgow and Clyde /ID# 162712
      • Luton, United Kingdom, LU4 0DZ
        • Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713
      • Poole, United Kingdom, BH15 2JB
        • Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711
    • Bath And North East Somerset
      • Bath, Bath And North East Somerset, United Kingdom, BA1 3NG
        • Royal United Hospitals Bath /ID# 161054
    • London, City of
      • London, London, City of, United Kingdom, E1 2ES
        • Barts Health NHS Trust /ID# 161053
      • London, London, City of, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust /ID# 161063
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608-1787
        • Alabama Medical Group, PC /ID# 159836
    • Arizona
      • Mesa, Arizona, United States, 85210-6871
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center Ltd. /ID# 161203
      • Phoenix, Arizona, United States, 85032-9306
        • Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
    • California
      • Beverly Hills, California, United States, 90211
        • Osteoporosis Medical Center /ID# 161411
      • Covina, California, United States, 91722
        • Covina Arthritis Clinic /ID# 159919
      • El Cajon, California, United States, 92020
        • Triwest Research Associates /ID# 159915
      • Fullerton, California, United States, 92835
        • Duplicate_Providence Medical Foundation /ID# 160005
      • Hemet, California, United States, 92543
        • C.V. Mehta MD, Med Corporation /ID# 161192
      • Huntington Beach, California, United States, 92648
        • Care Access Research, Huntington Beach /ID# 160049
      • La Mesa, California, United States, 91942
        • Purushotham & Akther Kotha MD, Inc /ID# 159834
      • Stanford, California, United States, 94305-2200
        • Stanford University School of Med /ID# 161402
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 159839
      • Whittier, California, United States, 90606
        • Medvin Clinical Research /ID# 160045
    • Colorado
      • Denver, Colorado, United States, 80230
        • Denver Arthritis Clinic /ID# 159899
      • Lakewood, Colorado, United States, 80228
        • Colorado Arthritis Associates /ID# 159856
    • Florida
      • Aventura, Florida, United States, 33180
        • Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409
      • Daytona Beach, Florida, United States, 32117
        • International Medical Research /ID# 160051
      • Miami Lakes, Florida, United States, 33016-1501
        • Precision Research Organization /ID# 161293
      • New Port Richey, Florida, United States, 34652
        • Duplicate_Suncoast Clinical Research /ID# 161417
      • Ormond Beach, Florida, United States, 32174
        • Millennium Research /ID# 159833
      • Palm Harbor, Florida, United States, 34684
        • Arthritis Center, Inc. /ID# 163463
      • Pensacola, Florida, United States, 32514
        • Gulf Region Clinical Res Inst /ID# 159860
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center /ID# 159854
      • St. Petersburg, Florida, United States, 33705
        • BayCare Medical Group /ID# 161405
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates /ID# 161412
      • Tampa, Florida, United States, 33612
        • USF Health Morsani Center for /ID# 161291
      • Tampa, Florida, United States, 33614-7101
        • BayCare Medical Group, Inc. /ID# 159912
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida - Tampa /ID# 160069
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida, Inc /ID# 159840
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic /ID# 160013
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Jefrey D. Lieberman, MD, P.C. /ID# 159842
      • Marietta, Georgia, United States, 20060
        • Atlanta Research Center for Rheumatology /ID# 161201
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research - Boise /ID# 159922
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials /ID# 163438
      • Libertyville, Illinois, United States, 60048
        • Deerbrook Medical Associates /ID# 159815
      • Skokie, Illinois, United States, 60076
        • Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • The Arthritis & Diabetes Clinic, Inc. /ID# 161294
    • Maryland
      • Frederick, Maryland, United States, 21204
        • Arthritis Treatment Center /ID# 160053
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research /ID# 159900
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Group /ID# 158712
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC /ID# 161208
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Westroads Clinical Research /ID# 160004
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Atlantic Coast Research /ID# 159810
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Duplicate_Arthritis and Osteo Assoc /ID# 160015
    • New York
      • Albany, New York, United States, 12203-3710
        • Center for Rheumatology LLP /ID# 167046
      • Potsdam, New York, United States, 13676
        • St. Lawrence Health System /ID# 159857
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • DJL Clinical Research, PLLC /ID# 161414
      • Greenville, North Carolina, United States, 27834
        • Physicians East, PA /ID# 159898
      • Raleigh, North Carolina, United States, 27617
        • Shanahan Rheuma & Immuno /ID# 160012
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC /ID# 161403
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Med Arts Clinic /ID# 159811
    • Ohio
      • Vandalia, Ohio, United States, 45377-9464
        • STAT Research, Inc. /ID# 161416
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research of Oklahoma /ID# 159913
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 159861
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh MC /ID# 161193
    • South Carolina
      • Summerville, South Carolina, United States, 29486-7887
        • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Rheumatology Consultants, PLLC /ID# 161408
      • Memphis, Tennessee, United States, 38119
        • Dr. Ramesh Gupta /ID# 160067
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, Inc. /ID# 160008
      • Beaumont, Texas, United States, 77701
        • Diagnostic Group /ID# 161406
      • College Station, Texas, United States, 77845
        • Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439
      • Corpus Christi, Texas, United States, 78404
        • Adriana Pop-Moody MD Clinic PA /ID# 160009
      • Dallas, Texas, United States, 75231
        • Metroplex Clinical Research /ID# 159818
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research /ID# 160052
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clin Res Ctr /ID# 161252
      • Lufkin, Texas, United States, 75904-3132
        • P&I Clinical Research /ID# 159837
      • Mesquite, Texas, United States, 75150
        • SW Rheumatology Res. LLC /ID# 160014
      • Tomball, Texas, United States, 77375
        • DM Clinical Research - Tomball /ID# 161753
      • Waco, Texas, United States, 76710
        • Arthritis & Osteoporosis Clinic /ID# 161400
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic of N. VA, P.C /ID# 159858
    • Washington
      • Seattle, Washington, United States, 98104
        • Duplicate_Swedish Medical Center /ID# 159918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upadacitinib 15 mg
Administered once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • ABT-494
Placebo Comparator: Placebo / Upadacitinib 30 mg
Administered once daily.
Drug: Placebo
Oral tablet
Drug: Upadacitinib
Oral tablet
Other Names:
  • ABT-494
Experimental: Upadacitinib 30 mg
Administered once daily.
Drug: Upadacitinib
Oral tablet
Other Names:
  • ABT-494
Placebo Comparator: Placebo / Upadacitinib 15 mg
Administered once daily.
Drug: Placebo
Oral tablet
Drug: Upadacitinib
Oral tablet
Other Names:
  • ABT-494

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) 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 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).
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and Week 12
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.
Baseline and Week 12
Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
Time Frame: Baseline and Week 16
The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
Baseline and Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
Time Frame: Baseline and Week 16

PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score.
Baseline and Week 16
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.
Baseline and Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
Time Frame: Baseline and 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, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue 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. A positive change from Baseline indicates improvement.
Baseline and Week 12
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Time Frame: Week 24

A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

  • Tender joint count (out of 68 joints) ≤ 1
  • Swollen joint count (out of 66 joints) ≤ 1
  • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
  • Patient's assessment of pain ≤ 1.5 (NRS from 0 to 10)
  • Patient's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
  • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
  • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
Week 24
Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
Time Frame: Baseline and 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. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
Baseline and Week 16
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).
Baseline and Week 12
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
Time Frame: Baseline and Week 2

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).
Baseline and Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

July 23, 2019

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M15-554
  • 2016-004152-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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