AzTrials
AzTrials

Psoriatic ArthritisPhase 3SELECT - PsA 2NCT03104374

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

A Phase 3 study testing Upadacitinib in people with Psoriatic Arthritis, run by AbbVie at 165 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Upadacitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
642 participants
Where
165 sitesin 19 countries
Study dates
1 May 2017to 30 Sep 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

165 sites in 19 countries.

165 sites in 19 countries

United States72 sites

  • Center for Rheumatology LLP /ID# 167046

    Albany, New York, 12203-3710

  • Arthritis Clinic of N. VA, P.C /ID# 159858

    Arlington, Virginia, 22205

  • Tekton Research, Inc. /ID# 160008

    Austin, Texas, 78745

  • Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409

    Aventura, Florida, 33180

  • Diagnostic Group /ID# 161406

    Beaumont, Texas, 77701

  • Osteoporosis Medical Center /ID# 161411

    Beverly Hills, California, 90211

  • DJL Clinical Research, PLLC /ID# 161414

    Charlotte, North Carolina, 28211

  • Great Lakes Clinical Trials /ID# 163438

    Chicago, Illinois, 60640

  • Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439

    College Station, Texas, 77845

  • Adriana Pop-Moody MD Clinic PA /ID# 160009

    Corpus Christi, Texas, 78404

  • Covina Arthritis Clinic /ID# 159919

    Covina, California, 91722

  • Metroplex Clinical Research /ID# 159818

    Dallas, Texas, 75231

  • International Medical Research /ID# 160051

    Daytona Beach, Florida, 32117

  • Jefrey D. Lieberman, MD, P.C. /ID# 159842

    Decatur, Georgia, 30033

  • Denver Arthritis Clinic /ID# 159899

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 159861

    Duncansville, Pennsylvania, 16635

  • Triwest Research Associates /ID# 159915

    El Cajon, California, 92020

  • Arthritis Treatment Center /ID# 160053

    Frederick, Maryland, 21204

  • Duplicate_Providence Medical Foundation /ID# 160005

    Fullerton, California, 92835

  • Physicians East, PA /ID# 159898

    Greenville, North Carolina, 27834

  • C.V. Mehta MD, Med Corporation /ID# 161192

    Hemet, California, 92543

  • Rheumatic Disease Clin Res Ctr /ID# 161252

    Houston, Texas, 77004

  • Accurate Clinical Research /ID# 160052

    Houston, Texas, 77089

  • Care Access Research, Huntington Beach /ID# 160049

    Huntington Beach, California, 92648

  • Rheumatology Consultants, PLLC /ID# 161408

    Knoxville, Tennessee, 37909

  • Purushotham & Akther Kotha MD, Inc /ID# 159834

    La Mesa, California, 91942

  • Colorado Arthritis Associates /ID# 159856

    Lakewood, Colorado, 80228

  • Duplicate_Arthritis and Osteo Assoc /ID# 160015

    Las Cruces, New Mexico, 88011

  • Deerbrook Medical Associates /ID# 159815

    Libertyville, Illinois, 60048

  • P&I Clinical Research /ID# 159837

    Lufkin, Texas, 75904-3132

  • Atlanta Research Center for Rheumatology /ID# 161201

    Marietta, Georgia, 20060

  • Dr. Ramesh Gupta /ID# 160067

    Memphis, Tennessee, 38119

  • Velocity Clinical Research - Boise /ID# 159922

    Meridian, Idaho, 83642

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047

    Mesa, Arizona, 85210-6871

  • SW Rheumatology Res. LLC /ID# 160014

    Mesquite, Texas, 75150

  • Precision Research Organization /ID# 161293

    Miami Lakes, Florida, 33016-1501

  • Trinity Health Med Arts Clinic /ID# 159811

    Minot, North Dakota, 58701

  • Alabama Medical Group, PC /ID# 159836

    Mobile, Alabama, 36608-1787

  • The Arthritis & Diabetes Clinic, Inc. /ID# 161294

    Monroe, Louisiana, 71203

  • Duplicate_Suncoast Clinical Research /ID# 161417

    New Port Richey, Florida, 34652

  • Health Research of Oklahoma /ID# 159913

    Oklahoma City, Oklahoma, 73103-2400

  • Westroads Clinical Research /ID# 160004

    Omaha, Nebraska, 68114

  • Millennium Research /ID# 159833

    Ormond Beach, Florida, 32174

  • Arthritis Center, Inc. /ID# 163463

    Palm Harbor, Florida, 34684

  • Gulf Region Clinical Res Inst /ID# 159860

    Pensacola, Florida, 32514

  • Sun Valley Arthritis Center Ltd. /ID# 161203

    Peoria, Arizona, 85381

  • Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006

    Phoenix, Arizona, 85032-9306

  • University of Pittsburgh MC /ID# 161193

    Pittsburgh, Pennsylvania, 15260

  • St. Lawrence Health System /ID# 159857

    Potsdam, New York, 13676

  • Shanahan Rheuma & Immuno /ID# 160012

    Raleigh, North Carolina, 27617

  • Sarasota Arthritis Center /ID# 159854

    Sarasota, Florida, 34239

  • Duplicate_Swedish Medical Center /ID# 159918

    Seattle, Washington, 98104

  • Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068

    Skokie, Illinois, 60076

  • Clinvest Research LLC /ID# 161208

    Springfield, Missouri, 65807

  • BayCare Medical Group /ID# 161405

    St. Petersburg, Florida, 33705

  • Stanford University School of Med /ID# 161402

    Stanford, California, 94305-2200

  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462

    Summerville, South Carolina, 29486-7887

  • West Broward Rheumatology Associates /ID# 161412

    Tamarac, Florida, 33321

  • Clinical Research of West Florida - Tampa /ID# 160069

    Tampa, Florida, 33606-1246

  • Clinical Research of West Florida, Inc /ID# 159840

    Tampa, Florida, 33606-1246

  • USF Health Morsani Center for /ID# 161291

    Tampa, Florida, 33612

  • BayCare Medical Group, Inc. /ID# 159912

    Tampa, Florida, 33614-7101

  • DM Clinical Research - Tomball /ID# 161753

    Tomball, Texas, 77375

  • Atlantic Coast Research /ID# 159810

    Toms River, New Jersey, 08755

  • Inland Rheum Clin Trials Inc. /ID# 159839

    Upland, California, 91786

  • STAT Research, Inc. /ID# 161416

    Vandalia, Ohio, 45377-9464

  • Arthritis & Osteoporosis Clinic /ID# 161400

    Waco, Texas, 76710

  • The Center for Rheumatology and Bone Research /ID# 159900

    Wheaton, Maryland, 20902

  • Medvin Clinical Research /ID# 160045

    Whittier, California, 90606

  • PMG Research of Wilmington LLC /ID# 161403

    Wilmington, North Carolina, 28401

  • Clinical Pharmacology Study Group /ID# 158712

    Worcester, Massachusetts, 01605

  • Florida Medical Clinic /ID# 160013

    Zephyrhills, Florida, 33542

Other trials in United States

Japan16 sites

  • Asahikawa Medical University Hospital /ID# 200684

    Asahikawa-shi, Hokkaido, 078-8510

  • Juntendo University Hospital /ID# 162089

    Bunkyo-ku, Tokyo, 113-8431

  • St.Luke's International Hospital /ID# 162013

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital /ID# 161774

    Fukuoka, Fukuoka, 814-0180

  • Kansai Medical University Hospital /ID# 162081

    Hirakata-shi, Osaka, 573-1191

  • National Hospital Organization Osaka Minami Medical Center /ID# 162589

    Kawachinagano Shi, Osaka, 586-8521

  • Duplicate_Kitakyushu Municipal Medical Center /ID# 163516

    Kitakyushu-shi, Fukuoka, 802-8561

  • Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472

    Kitakyushu-shi, Fukuoka, 807-8556

  • Daido Hospital /ID# 163639

    Nagoya, Aichi-ken, 457-8511

  • Nagoya City University Hospital /ID# 162563

    Nagoya, Aichi-ken, 467-8602

  • Oribe Clinic of Rheumatism and Medicine /ID# 163704

    Ōita, Oita Prefecture, 870-0823

  • Osaka Metropolitan University Hospital /ID# 162082

    Osaka, Osaka, 545-8586

  • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773

    Osaka, Osaka, 550-0006

  • Tohoku University Hospital /ID# 164035

    Sendai, Miyagi, 9808574

  • Keio University Hospital /ID# 162130

    Shinjuku-ku, Tokyo, 160-8582

  • Mie University Hospital /ID# 162085

    Tsu, Mie-ken, 514-8507

Other trials in Japan

Italy8 sites

  • Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 162748

    Ancona, 60126

  • Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 164126

    Catania, 95123

  • Duplicate_AOU Arcispedale Sant Anna di /ID# 164127

    Cona, 44124

  • ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 164125

    Milan, 20122

  • Azienda Ospedaliera Universitaria Federico II /ID# 202410

    Naples, L Aquila, 80131

  • Duplicate_Azienda Unita Sanitaria Locale/IRCCS /ID# 162751

    Reggio Emilia, 42123

  • Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 164123

    Rome, Roma, 00128

  • Duplicate_Fondazione PTV Policlinico Tor Vergata /ID# 162749

    Rome, Roma, 00133

Other trials in Italy

Brazil7 sites

  • CIP - Centro Internacional de Pesquisa /ID# 161808

    Goiânia, Goiás, 74110-120

  • Hospital de Clinicas de Porto Alegre /ID# 161795

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 161806

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Duplicate_Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 163317

    Ribeirão Preto, São Paulo, 14051-140

  • Faculdade de Medicina do ABC /ID# 163489

    Santo André, La Spezia, 09060-870

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 161793

    São Paulo, 05403-000

  • Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794

    Uberlândia, Minas Gerais, 38400-902

Other trials in Brazil

Hungary7 sites

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 170911

    Budapest, 1023

  • Revita Reumatologiai Rendelo /ID# 162575

    Budapest, 1027

  • Obudai Egeszsegugyi Centrum Kft. /ID# 162576

    Budapest, 1036

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 162572

    Debrecen, 4031

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 162573

    Győr, Győr-Moson-Sopron, 9024

  • MÁV Kórház /ID# 162574

    Szolnok, 5000

  • Vital Medicina Kft /ID# 162571

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

France6 sites

  • CHRU Tours - Hopital Trousseau /ID# 163772

    Chambray-lès-Tours, 37170

  • Duplicate_CHU-Hospital Henri Mondor /ID# 163895

    Créteil, 94010

  • Centre Hospitalier du Mans /ID# 163746

    Le Mans, Sarthe, 72037

  • Hopital Saint Joseph /ID# 163755

    Marseille, Bouches-du-Rhone, 13008

  • Duplicate_AP-HP - Hopital Lariboisiere /ID# 163773

    Paris, 75010

  • CHU Toulouse /ID# 163743

    Toulouse, Occitanie, 31300

Other trials in France

United Kingdom6 sites

  • Royal United Hospitals Bath /ID# 161054

    Bath, Bath And North East Somerset, BA1 3NG

  • Duplicate_NHS Greater Glasgow and Clyde /ID# 162712

    Glasgow, G12 0XH

  • Barts Health NHS Trust /ID# 161053

    London, London, City of, E1 2ES

  • Guys and St Thomas NHS Foundation Trust /ID# 161063

    London, London, City of, SE1 9RT

  • Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713

    Luton, LU4 0DZ

  • Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711

    Poole, BH15 2JB

Other trials in United Kingdom

Canada5 sites

  • The Waterside Clinic /ID# 157838

    Orillia, Ontario, L3V 1T5

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 157836

    Sainte-Foy, Quebec, G1V 3M7

  • Centre de Recherche Musculo-Squelettique /ID# 163557

    Trois-Rivières, Quebec, G8Z 1Y2

  • Percuro Clinical Research, Ltd /ID# 157835

    Victoria, British Columbia, V8V 3M9

  • CIADS Research Co Ltd /ID# 157843

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Portugal5 sites

  • Instituto Portugues De Reumatologia /ID# 165894

    Lisbon, 1050-034

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896

    Lisbon, 1349-019

  • Unidade Local de Saude de Santa Maria, EPE /ID# 165895

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898

    Ponte de Lima, Viana do Castelo District, 4990-041

  • Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Spain5 sites

  • Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019

    A Coruña, 15006

  • Duplicate_Hospital Universitario Reina Sofia /ID# 170764

    Córdoba, 14004

  • Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138

    El Palmar, Murcia, 30120

  • Hospital Campus de la Salud /ID# 170768

    Granada, 18016

  • Hospital Universitario Ramon y Cajal /ID# 161020

    Madrid, 28034

Other trials in Spain

Australia4 sites

  • Emeritus Research Sydney /ID# 166751

    Botany, New South Wales, 2019

  • Box Hill Hospital /ID# 166752

    Box Hill, Victoria, 3128

  • Heidelberg Repatriation Hospital /ID# 167441

    Heidelberg West, Victoria, 3081

  • The Queen Elizabeth Hospital /ID# 200840

    Woodville South, South Australia, 5011

Other trials in Australia

Chile4 sites

  • CTR Estudios Clinicos /ID# 206038

    Providencia, Aysén, 7500571

  • Duplicate_Clinica Dermacross /ID# 169537

    Santiago, 7640881

  • Duplicate_Centro Internacional de Estudios Clinicos /ID# 169543

    Santiago, 8420383

  • Prosalud Ltda. /ID# 169542

    Santiago, ZC:7510047

Other trials in Chile

Netherlands4 sites

  • Medisch Centrum Leeuwarden /ID# 163049

    Leeuwarden, South Holland, 8934 AD

  • Duplicate_Erasmus Medisch Centrum /ID# 163052

    Rotterdam, South Holland, 3015 GD

  • Maasstad Ziekenhuis /ID# 163050

    Rotterdam, South Holland, 3079 DZ

  • Sint Maartenskliniek /ID# 163703

    Ubbergen, 6574 NA

Other trials in Netherlands

New Zealand4 sites

  • Waikato Hospital /ID# 166412

    Hamilton, Waikato Region, 3240

  • Porter Rheumatology Ltd /ID# 200422

    Nelson, 7010

  • Duplicate_Middlemore Hospital /ID# 166411

    Otahuhu, Auckland, 2025

  • Timaru Medical Specialists Ltd /ID# 166410

    Timaru, Canterbury, 7910

Other trials in New Zealand

Greece3 sites

  • General Hospital of Athens Laiko /ID# 163474

    Athens, Attica, 11527

  • Naval Hospital of Athens /ID# 163495

    Athens, 11521

  • Reg Gen Univ Hosp Larissa /ID# 163493

    Larissa, 41110

Other trials in Greece

Puerto Rico3 sites

  • Alma M. Cruz Santana, MD-Private practice /ID# 163308

    Carolina, 00985

  • Ponce Medical School Foundation /ID# 163918

    Ponce, 00716-0377

  • GCM Medical Group PSC /ID# 163716

    San Juan, 00917-3104

Other trials in Puerto Rico

Belgium2 sites

  • ReumaClinic /ID# 164214

    Genk, Limburg, 3600

  • UZ Gent /ID# 164210

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

Czechia2 sites

  • Revmatologie Bruntal, s.r.o /ID# 159632

    Prostějov, 796 01

  • Medical Plus, s.r.o. /ID# 159631

    Uherské Hradiště, 686 01

Other trials in Czechia

South Korea2 sites

  • Duplicate_Inha University Hospital /ID# 163892

    Junggu, Incheon Gwang Yeogsi, 22332

  • Duplicate_Ajou University Hospital /ID# 163893

    Suwon, Gyeonggido, 16499

Other trials in South Korea

About this study

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)

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.

Read the 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.

Being tested
Placebo, Upadacitinib
Keywords
Arthritis, Psoriasis, Anti-Rheumatic, Anti-inflammatory, Joint disease, Musculoskeletal disease
Medical subject headings
Arthritis, Psoriatic, Arthritis, Psoriasis, Joint Diseases, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Oral tablet

  • UpadacitinibDrug

    Also called ABT-494

    Oral tablet

Study groups in NCT03104374
Study groupRoleWhat they receive
Upadacitinib 15 mgExperimentalAdministered once daily.
Receives: Drug: Upadacitinib
Placebo / Upadacitinib 30 mgPlacebo comparatorAdministered once daily.
Receives: Drug: Placebo; Drug: Upadacitinib
Upadacitinib 30 mgExperimentalAdministered once daily.
Receives: Drug: Upadacitinib
Placebo / Upadacitinib 15 mgPlacebo comparatorAdministered once daily.
Receives: Drug: Placebo; Drug: Upadacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response 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).

    Measured: Baseline and Week 12

Secondary outcomes (10)

  1. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at 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.

    Measured: Baseline and Week 12

  2. 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

    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).

    Measured: Baseline and Week 16

  3. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at 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.

    Measured: Baseline and Week 16

  4. Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at 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.

    Measured: Baseline and Week 12

  5. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.

    Measured: Baseline and Week 12

  6. Percentage of Participants Achieving Minimal Disease Activity (MDA) at 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)

    Measured: Week 24

  7. Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at 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.

    Measured: Baseline and Week 16

  8. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at 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).

    Measured: Baseline and Week 12

  9. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at 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).

    Measured: Baseline and Week 12

  10. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at 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).

    Measured: Baseline and Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2017
  2. Study start1 May 2017
  3. Primary completion23 Jul 2019
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
642 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104374
Sponsor's protocol ID
M15-554
Other IDs
2016-004152-30, 2016
Acronym
SELECT - PsA 2
Status last verified
Aug 2025
First submitted
4 Apr 2017
Last updated
11 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.

    PubMed 40875187

  • Poddubnyy D, Parikh B, Elewaut D, Navarro-Compan V, Siebert S, Paley M, Coombs D, Lagunes I, Biljan A, Nakasato P, Wung P, Lubrano E. Development of Extramusculoskeletal Manifestations in Upadacitinib-Treated Patients With Psoriatic Arthritis or Axial Spondyloarthritis. Arthritis Rheumatol. 2025 May;77(5):536-546. doi: 10.1002/art.43069. Epub 2025 Jan 24.

    PubMed 39624020

  • Burmester GR, Stigler J, Rubbert-Roth A, Tanaka Y, Azevedo VF, Coombs D, Lagunes I, Lippe R, Wung P, Gensler LS. Safety Profile of Upadacitinib up to 5 Years in Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis: An Integrated Analysis of Clinical Trials. Rheumatol Ther. 2024 Jun;11(3):737-753. doi: 10.1007/s40744-024-00671-4. Epub 2024 Apr 29.

    PubMed 38683479

  • Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon-Blondell EL, Gao T, McGonagle D, Salvarani C. Effects of upadacitinib on enthesitis in patients with psoriatic arthritis: a post hoc analysis of SELECT-PsA 1 and 2 trials. Rheumatology (Oxford). 2024 Nov 1;63(11):3146-3154. doi: 10.1093/rheumatology/keae057.

    PubMed 38331400

  • Rubbert-Roth A, Kakehasi AM, Takeuchi T, Schmalzing M, Palac H, Coombs D, Liu J, Anyanwu SI, Lippe R, Curtis JR. Malignancy in the Upadacitinib Clinical Trials for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis. Rheumatol Ther. 2024 Feb;11(1):97-112. doi: 10.1007/s40744-023-00621-6. Epub 2023 Nov 20.

    PubMed 37982966

  • Charles-Schoeman C, Choy E, McInnes IB, Mysler E, Nash P, Yamaoka K, Lippe R, Khan N, Shmagel AK, Palac H, Suboticki J, Curtis JR. MACE and VTE across upadacitinib clinical trial programmes in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. RMD Open. 2023 Nov;9(4):e003392. doi: 10.1136/rmdopen-2023-003392.

    PubMed 37945286

  • Mease P, Setty A, Papp K, Van den Bosch F, Tsuji S, Keiserman M, Carter K, Li Y, McCaskill R, McDearmon-Blondell E, Wung P, Tillett W. Upadacitinib in patients with psoriatic arthritis and inadequate response to biologics: 3-year results from the open-label extension of the randomised controlled phase 3 SELECT-PsA 2 study. Clin Exp Rheumatol. 2023 Nov;41(11):2286-2297. doi: 10.55563/clinexprheumatol/8l7bbk. Epub 2023 Jul 5.

    PubMed 37404160

  • Burmester GR, Cohen SB, Winthrop KL, Nash P, Irvine AD, Deodhar A, Mysler E, Tanaka Y, Liu J, Lacerda AP, Palac H, Shaw T, Mease PJ, Guttman-Yassky E. Safety profile of upadacitinib over 15 000 patient-years across rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and atopic dermatitis. RMD Open. 2023 Feb;9(1):e002735. doi: 10.1136/rmdopen-2022-002735.

    PubMed 36754548

  • Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.

    PubMed 35606663

  • Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.

    PubMed 34970731

  • Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.

    PubMed 34864911

  • Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.

    PubMed 34661885

  • Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27.

    PubMed 34464029

  • Mease PJ, Lertratanakul A, Papp KA, van den Bosch FE, Tsuji S, Dokoupilova E, Keiserman MW, Bu X, Chen L, McCaskill RM, Zueger P, McDearmon-Blondell EL, Pangan AL, Tillett W. Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study. Rheumatol Ther. 2021 Jun;8(2):903-919. doi: 10.1007/s40744-021-00305-z. Epub 2021 Apr 28.

    PubMed 33913086

  • Mease PJ, Lertratanakul A, Anderson JK, Papp K, Van den Bosch F, Tsuji S, Dokoupilova E, Keiserman M, Wang X, Zhong S, McCaskill RM, Zueger P, Pangan AL, Tillett W. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2021 Mar;80(3):312-320. doi: 10.1136/annrheumdis-2020-218870. Epub 2020 Dec 3.

    PubMed 33272960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib in people with Psoriatic Arthritis, run by AbbVie at 165 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 165 sites in United States, Japan, Italy, Brazil, Hungary and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104374, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.

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