AzTrials
AzTrials

Psoriatic ArthritisPhase 3SELECT - PsA 1NCT03104400

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

A Phase 3 study testing Adalimumab and Upadacitinib in people with Psoriatic Arthritis, run by AbbVie at 345 sites in 46 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 study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic… 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?
Adalimumab and Upadacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,705 participants
Where
345 sitesin 46 countries
Study dates
27 Apr 2017to 9 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.
  • Presence of either at Screening:
  • >= 1 erosion on x-ray as determined by central imaging review or;
  • high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).
  • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Show all 11Show fewer
  • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
  • Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
  • Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:
  • >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
  • >= 4 weeks for all others.

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, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
  • 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 nonradiographic 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

345 sites in 46 countries.

345 sites in 46 countries

United States114 sites

  • Univ of Michigan Hospitals /ID# 164014

    Ann Arbor, Michigan, 48109

  • Arthritis Clinic of N. VA, P.C /ID# 159849

    Arlington, Virginia, 22205

  • Johns Hopkins University /ID# 167665

    Baltimore, Maryland, 21224

  • Accurate Clinical Management /ID# 159905

    Baytown, Texas, 77521

  • Diagnostic Group Integrated He /ID# 159794

    Beaumont, Texas, 77701

  • Tufts Medical Center /ID# 165144

    Boston, Massachusetts, 02111

  • Graves Gilbert Clinic /ID# 161285

    Bowling Green, Kentucky, 42101

  • American Health Research /ID# 164354

    Charlotte, North Carolina, 28207

  • DJL Clinical Research, PLLC /ID# 161390

    Charlotte, North Carolina, 28210-8508

  • Ctr for Arth and Rheum Disease /ID# 159830

    Chesapeake, Virginia, 23320

  • Great Lakes Clinical Trials /ID# 163435

    Chicago, Illinois, 60640

  • Clinical Res of West FL, Inc. /ID# 159829

    Clearwater, Florida, 33765

  • MetroHealth Medical Center /ID# 159888

    Cleveland, Ohio, 44109

  • Arth and Osteo Clin Brazo Valley /ID# 163436

    College Station, Texas, 77845

  • PCCR Solution /ID# 205723

    Colleyville, Texas, 76034

  • The Ohio State University /ID# 159892

    Columbus, Ohio, 43210

  • Adriana Pop-Moody MD Clinic PA /ID# 159984

    Corpus Christi, Texas, 78404

  • Covina Arthritis Clinic /ID# 159891

    Covina, California, 91722

  • Klein & Associates, M.D., P.A. /ID# 164013

    Cumberland, Maryland, 21502

  • Metroplex Clinical Research /ID# 159785

    Dallas, Texas, 75231

  • International Medical Research - Daytona /ID# 160040

    Daytona Beach, Florida, 32117

  • Omega Research Maitland, LLC /ID# 164193

    DeBary, Florida, 32713-2260

  • Denver Arthritis Clinic /ID# 159873

    Denver, Colorado, 80230

  • St. Luke's Hospital of Duluth /ID# 165671

    Duluth, Minnesota, 55805

  • Altoona Ctr Clinical Res /ID# 159852

    Duncansville, Pennsylvania, 16635

  • M3-Emerging Medical Research, LLC /ID# 161391

    Durham, North Carolina, 27704

  • Arthritis and Rheum Clin N. CO /ID# 160039

    Fort Collins, Colorado, 80528

  • Aurora Rheumatology and Immunotherapy Center /ID# 160043

    Franklin, Wisconsin, 53132

  • Arthritis and Osteoporosis Associates /ID# 159802

    Freehold, New Jersey, 07728

  • St. Joseph Heritage Healthcare /ID# 159980

    Fullerton, California, 92835

  • Aa Mrc Llc /Id# 159846

    Grand Blanc, Michigan, 48439

  • Physicians East, PA /ID# 159872

    Greenville, North Carolina, 27834

  • C.V. Mehta MD, Med Corporation /ID# 161216

    Hemet, California, 92543

  • Rheumatic Disease Clin Res Ctr /ID# 161240

    Houston, Texas, 77004

  • Rheumatology Clinic of Houston /ID# 161234

    Houston, Texas, 77065

  • "DMCR-Texas Cent for Drug Dev /ID# 164191

    Houston, Texas, 77081

  • Care Access Research, Huntingt /ID# 160038

    Huntington Beach, California, 92648

  • Rheum Assoc of North Alabama /ID# 163231

    Huntsville, Alabama, 35801

  • Institute of Arthritis Researc /ID# 165873

    Idaho Falls, Idaho, 83404

  • West Tennessee Research Inst /ID# 159871

    Jackson, Tennessee, 38305

  • Glacier View Research Institut /ID# 167023

    Kalispell, Montana, 59901

  • Rheumatology Consultants, PLLC /ID# 159796

    Knoxville, Tennessee, 37909

  • Kotha and Kotha /ID# 159823

    La Mesa, California, 91942

  • TriWest Research Associates- La Mesa /ID# 159887

    La Mesa, California, 91942

  • Arthritis & Osteo Medical Ctr /ID# 166760

    La Palma, California, 90623-1728

  • NYU Langone Rheum Assoc /ID# 159985

    Lake Success, New York, 11554

  • Colorado Arthritis Associates /ID# 159847

    Lakewood, Colorado, 80228

  • Advanced Rheumatology, PC /ID# 159893

    Lansing, Michigan, 48910

  • Beals Institute PC /ID# 163128

    Lansing, Michigan, 48917

  • Arthritis and Osteo Assoc /ID# 159994

    Las Cruces, New Mexico, 88011

  • Dartmouth-Hitchcock Medical Center /ID# 161235

    Lebanon, New Hampshire, 03756

  • Cape Fear Arthritis Care /ID# 161224

    Leland, North Carolina, 28451

  • Little Rock Diagnostics Clinic /ID# 165161

    Little Rock, Arkansas, 72205

  • University of California, Los Angeles /ID# 164542

    Los Angeles, California, 90095

  • West Texas Clinical Research /ID# 205722

    Lubbock, Texas, 79410-1198

  • P&I Clinical Research /ID# 159826

    Lufkin, Texas, 75904-3132

  • Mansfield Health Center /ID# 159805

    Mansfield, Massachusetts, 02048

  • VA Sacramento Medical Center /ID# 164196

    Mather, California, 95655

  • Dr. Ramesh Gupta /ID# 160061

    Memphis, Tennessee, 38119

  • Advanced Clinical Research /ID# 159894

    Meridian, Idaho, 83642

  • SW Rheumatology Res. LLC /ID# 159993

    Mesquite, Texas, 75150

  • LeJenue Research Associates /ID# 170965

    Miami, Florida, 33126

  • Precision Research Org, LLC /ID# 161287

    Miami Lakes, Florida, 33016-1501

  • Trinity Health Med Arts Clinic /ID# 159800

    Minot, North Dakota, 58701

  • Medallion Clinical Research Institute, LLC /ID# 161228

    Naples, Florida, 34102

  • Ochsner Clinic Foundation-New Orleans /ID# 165672

    New Orleans, Louisiana, 70121

  • NYU Langone Medical Center /ID# 163230

    New York, New York, 10016-6402

  • Health Research of Oklahoma /ID# 159880

    Oklahoma City, Oklahoma, 73103-2400

  • Westroads Clinical Research /ID# 159979

    Omaha, Nebraska, 68114

  • Millennium Research /ID# 159822

    Ormond Beach, Florida, 32174

  • Four Rivers Clinical Research /ID# 159982

    Paducah, Kentucky, 42001

  • Arthritis Center, Inc. /ID# 163465

    Palm Harbor, Florida, 34684

  • Gulf Region Clinical Res Inst /ID# 159851

    Pensacola, Florida, 32514

  • SunValley Arthritis Center, Lt /ID# 161221

    Peoria, Arizona, 85381

  • Clinical Research Source, Inc. /ID# 164545

    Perrysburg, Ohio, 43551

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 159981

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 160033

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 160036

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis & Rheuma Research /ID# 160037

    Phoenix, Arizona, 85032

  • Trinity Universal Research Association /ID# 205721

    Plano, Texas, 75024-5283

  • St. Lawrence Health System /ID# 159848

    Potsdam, New York, 13676

  • Shanahan Rheuma & Immuno /ID# 159987

    Raleigh, North Carolina, 27617

  • OrthoIllinois /ID# 164546

    Rockford, Illinois, 61114-4937

  • Shores Rheumatology, PC /ID# 159889

    Saint Clair Shores, Michigan, 48081

  • Arthritis & Osteo Ctr of S. TX /ID# 163784

    San Antonio, Texas, 78232

  • East Bay Rheumatology Medical /ID# 166382

    San Leandro, California, 94578

  • Arthritis Clinic of Central TX /ID# 164049

    San Marcos, Texas, 78666

  • Santa Fe Rheumatology /ID# 163783

    Santa Fe, New Mexico, 87505

  • Swedish Medical Center /ID# 159890

    Seattle, Washington, 98104

  • Clinical Investigation Specialists - Skokie /ID# 160062

    Skokie, Illinois, 60076

  • West Virginia Research Inst /ID# 159791

    South Charleston, West Virginia, 25309

  • Arthritis Northwest, PLLC /ID# 166380

    Spokane, Washington, 99204

  • Clinvest Research LLC /ID# 161227

    Springfield, Missouri, 65810-2607

  • Clayton Medical Associates dba Saint Louis Rheumatology /ID# 159878

    St Louis, Missouri, 63119-3845

  • BayCare Medical Group /ID# 159792

    St. Petersburg, Florida, 33705

  • Stamford Therapeutics Consorti /ID# 165131

    Stamford, Connecticut, 06905

  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163464

    Summerville, South Carolina, 29486-7887

  • W. Broward Rheum Assoc Inc. /ID# 161388

    Tamarac, Florida, 33321

  • Clinical Research of West Florida, Inc /ID# 160063

    Tampa, Florida, 33606-1246

  • University of South Florida /ID# 161286

    Tampa, Florida, 33612

  • BayCare Medical Group, Inc. /ID# 159879

    Tampa, Florida, 33614-7101

  • DM Clinical Research /ID# 161735

    Tomball, Texas, 77375

  • Atlantic Coast Research /ID# 159799

    Toms River, New Jersey, 08755

  • Ocean Rheumatology, PA /ID# 163898

    Toms River, New Jersey, 08755

  • AZ Arth & Rheum Res /ID# 166381

    Tucson, Arizona, 85704

  • Inland Rheum Clin Trials Inc. /ID# 159828

    Upland, California, 91786

  • STAT Research, Inc. /ID# 161392

    Vandalia, Ohio, 45377-9464

  • Deerbrook Medical Associates /ID# 159804

    Vernon Hills, Illinois, 60061

  • Arthritis & Osteoporosis Clinic /ID# 159786

    Waco, Texas, 76710

  • The Center for Rheumatology & Bone Research /ID# 159874

    Wheaton, Maryland, 20902

  • Medvin Clinical Research /ID# 160034

    Whittier, California, 90606

  • Clinical Pharmacology Study Gr /ID# 158700

    Worcester, Massachusetts, 01605

  • PA Regional Center /ID# 165670

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic /ID# 159992

    Zephyrhills, Florida, 33542

Other trials in United States

China15 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Monggolia Univers /ID# 171204

    Baotou, Inner Mongolia, 014016

  • Peking University Third Hospital /ID# 201973

    Beijing, Beijing Municipality, 100191

  • 1st Aff Hosp of Bengbu Medical College /ID# 201021

    Bengbu, Anhui, 233004

  • West China Hospital /ID# 200199

    Chengdu, Sichuan, 610041

  • The Aff Hosp Inner Mongolia /ID# 207787

    Hohhot, 010050

  • First Affiliated Hospital of Kunming Medical University /ID# 201264

    Kunming, 650032

  • The First People's Hospital of Linyi /ID# 201970

    Linyi, Shandong, 276034

  • Affiliated hospital of nantong university /ID# 208234

    Nantong, 226001

  • Ningbo First Hospital /ID# 201874

    Ningbo, Zhejiang, 315010

  • Huashan Hospital of Fudan University /ID# 202191

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Changhai Hospital /ID# 200202

    Shanghai, Shanghai Municipality, 200433

  • The First Affiliated Hospital of Shantou University Medical College /ID# 203371

    Shantou, Guangdong, 515041

  • The First Affiliated Hospital of Soochow University /ID# 201875

    Suzhou, 215006

  • People's Hospital of Xinjiang /ID# 201592

    Ürümqi, 830001

  • Zhuzhou Central Hospital /ID# 200201

    Zhuzhou, Hunan, 412007

Other trials in China

Poland14 sites

  • Malopolskie Centrum Kliniczne /ID# 163777

    Cracow, Lesser Poland Voivodeship, 30-149

  • Centrum Kliniczno-Badawcze /ID# 161830

    Elblag, 82-300

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku /ID# 206299

    Gdansk, Pomeranian Voivodeship, 80-382

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 207157

    Gdynia, Pomeranian Voivodeship, 81-537

  • Synexus Polska Sp. z o.o. Oddzial Katowice /ID# 204510

    Katowice, Silesian Voivodeship, 40-040

  • Krakowskie Centrum Medyczne /ID# 206302

    Krakow, 31-501

  • Salve Medica Sp. z o.o. S.K. /ID# 206300

    Lodz, Łódź Voivodeship, 91-211

  • ETYKA-Osrodek Badan Klinicznyc /ID# 163776

    Olsztyn, Warmian-Masurian Voivodeship, 10-117

  • Synexus Polska Sp. z o.o. Oddzial w Poznaniu /ID# 207158

    Poznan, 60-702

  • NZOZ Nasz Lekarz /ID# 163774

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Medycyna Kliniczna /ID# 166288

    Warsaw, 00-874

  • Synexus Polska Sp. z.o.o. /ID# 203987

    Warsaw, 01-192

  • Reumatika - Centrum Reumatologii NZOZ /ID# 161831

    Warsaw, 02-691

  • Synexus Polska Sp. z o.o. /ID# 204506

    Wroclaw, Lower Silesian Voivodeship, 50-381

Other trials in Poland

Brazil11 sites

  • Instituto de Ciencias Farmacêuticas /ID# 163274

    Aparecida de Goiânia, Goiás, 74935-530

  • EDUMED Educacao em Saude S/S L /ID# 161816

    Curitiba, Paraná, 80440-080

  • CIP - Centro Internacional de Pesquisa /ID# 161821

    Goiânia, Goiás, 74110-120

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 161819

    Juiz de Fora, Minas Gerais, 36010-570

  • Instituto de Educação e Pesquisa do Hospital Moinhos de Vento /ID# 161813

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital de Clinicas de Porto Alegre /ID# 161820

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 161812

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163273

    Ribeirão Preto, São Paulo, 14049-900

  • Faculdade de Medicina do ABC /ID# 163491

    Santo André, São Paulo, 09060-870

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos do ABC /ID# 161810

    Santo André, São Paulo, 09190-510

  • CPCLIN - Centro de Pesquisas Clínicas /ID# 161818

    São Paulo, 01244-030

Other trials in Brazil

Ukraine11 sites

  • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 164170

    Kharkiv, Kharkiv Oblast, 61039

  • Kharkiv Regional Council Regional Clinical Hospital /ID# 210189

    Kharkiv, 61058

  • NSC Strazhesko Ist Cardiology /ID# 164043

    Kiev, 03680

  • Med Ctr of Private High Ed Ins /ID# 208527

    Kyiv, 02002

  • Medical Center of LLC Medbud-Clinic /ID# 208528

    Kyiv, 03037

  • Kyiv Railway Clinical Hosp No.2 /ID# 208951

    Kyiv, 03049

  • LLC Revmocentr /ID# 164177

    Kyiv, 04070

  • MNI KRC Kyiv Regional Clinical Hospital /ID# 210188

    Kyiv, 04107

  • Lviv Regional Clinical Hospita /ID# 164178

    Lviv, Lviv Oblast, 79013

  • Odessa National Medical Univ /ID# 164244

    Odesa, 65026

  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 164245

    Vinnytsia, 21018

Other trials in Ukraine

Hungary10 sites

  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz /ID# 170719

    Budapest, 1023

  • Revita Reumatologiai Rendelo /ID# 163277

    Budapest, 1027

  • Obudai Egeszsegugyi Centrum Kft. /ID# 163279

    Budapest, 1036

  • Synexus Magyarorszag Kft. /ID# 203012

    Budapest, 1036

  • Qualiclinic Kft. /ID# 163278

    Budapest III, Pest County, 1036

  • Debreceni Egyetem Kenezy Gyula /ID# 163276

    Debrecen, 4031

  • Synexus Magyarorszag Kft. - Gyula DRS /ID# 202209

    Gyula, Bekes County, 5700

  • Szabolcs-Szatmar-Bereg Megyei Korhazak & Egyetemi Oktatok.- Klinikai Kutatasi O. /ID# 202584

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Vital Medical Center Orvosi-es Fogaszati Kozpont /ID# 163275

    Veszprém, 8200

  • Synexus Magyarorszag Kft. - Zalaegerszeg AS /ID# 201884

    Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Argentina9 sites

  • Organizacion Medica de Investigacion (OMI) /ID# 160118

    Buenos Aires, 1015

  • Hospital General de Agudos Ram /ID# 164378

    Buenos Aires, 1221

  • Psoriahue Med Interdisciplinar /ID# 160506

    Buenos Aires, 1425

  • Inst. de Rehab. Psicofisica /ID# 165154

    CABA, 1428

  • Instituto CAICI /ID# 160119

    Rosario, Santa FE, 2000

  • Centro Medico Privado/Reuma /ID# 159775

    San Miguel de Tucumán, Ciuadad Autonoma de Buenos Aires, 4000

  • Centro Integral de Medicina Respiratoria (CIMER) /ID# 211237

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro Integral de Medicina Re /ID# 160258

    SAN Miguel de Tucuman, Latam, 4000

  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 165795

    Santa Fe, 2000

Other trials in Argentina

Germany8 sites

  • Immanuel-Krankenhaus /ID# 163931

    Buch, 13125

  • University Clinic Carl Gustav /ID# 163926

    Dresden, 01307

  • Polikilinik fuer Rheumatologie /ID# 163933

    Düsseldorf, 40225

  • Cent fur Innovative Diagnostik /ID# 163927

    Frankfurt, 60590

  • Hamburger Rheuma Forschungszentrum II im MVZ Rheumatologie und Autoimmunmedizin /ID# 204421

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 163930

    Herne, North Rhine-Westphalia, 44649

  • Dr. med. Jochen Walter FA fuer /ID# 168638

    Rendsburg, 24768

  • Med. Universitaetsklinik Inner /ID# 163929

    Tübingen, 72076

Other trials in Germany

Bulgaria7 sites

  • Department of Rheumatology, Mu /ID# 169606

    Plovdiv, 4003

  • Excelsior Medical Center /ID# 169609

    Sofia, 1407

  • Multiprofile Hospital for Active Treatment - Sofia at Military Medical Academy /ID# 169608

    Sofia, 1606

  • UMHAT Sv. Ivan Rilski /ID# 202393

    Sofia, 1612

  • Medical Centre Synexus Sofia /ID# 202394

    Sofia, 1784

  • Medical Centre Synexus Sofia, branch Stara Zagora /ID# 202524

    Stara Zagora, 6000

  • Diagnostic Consultative Center /ID# 169607

    Varna, 9000

Other trials in Bulgaria

Portugal7 sites

  • Instituto Portugues De Reumatologia /ID# 165858

    Lisbon, Lisbon District, 1050-034

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 165861

    Lisbon, Lisbon District, 1349-019

  • Centro Hospitalar Lisboa Norte, EPE /ID# 165860

    Lisbon, 1649-035

  • Hospital CUF Descobertas /ID# 165866

    Lisbon, 1998-018

  • Hospital Beatriz Angelo /ID# 165865

    Loures, 2674-514

  • Unidade Local De Saude Do Alto Minho /ID# 165863

    Viana do Castelo, 4901-858

  • Centro Hospitalar de Vila Nova Gaia/Espinho, EPE /ID# 165862

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Canada6 sites

  • The Waterside Clinic /ID# 157826

    Barrie, Ontario, L4M 6L2

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 157824

    Sainte-Foy, Quebec, G1V 3M7

  • Ctr. de Recherche Musculo-Sque /ID# 207069

    Trois-Rivières, Quebec, G8Z 1Y2

  • Percuro Clinical Research, Ltd /ID# 157823

    Victoria, British Columbia, V8V 3M9

  • Manitoba Clinic /ID# 157829

    Winnipeg, Manitoba, R3A 1M3

  • Ciads /Id# 157831

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Greece6 sites

  • General Hospital of Athens Laiko /ID# 163476

    Athens, Attica, 115 27

  • General Hospital of Athens Laiko /ID# 163478

    Athens, Attica, 115 27

  • University General Hospital Attikon /ID# 163477

    Athens, Attica, 12462

  • Naval Hospital of Athens /ID# 163486

    Athens, 11521

  • University General Hospital of Heraklion PA.G.N.I /ID# 163472

    Heraklion, 71110

  • Reg Gen Univ Hosp Larissa /ID# 163496

    Larissa, 41110

Other trials in Greece

Japan6 sites

  • St.Luke's International Hospital /ID# 162016

    Chuo-ku, Tokyo, 104-8560

  • Fukuoka University Hospital /ID# 162086

    Fukuoka, Fukuoka, 814-0180

  • National Hospital Organization Osaka Minami Medical Center /ID# 162590

    Kawachinagano-shi, Osaka, 586-8521

  • Hospital of the University of Occupational and Environmental Health /ID# 161473

    Kitakyushu-shi, Fukuoka, 807-8556

  • Nagoya City University Hospital /ID# 162564

    Nagoya, Aichi-ken, 467-8602

  • Mie University Hospital /ID# 162080

    Tsu, Mie-ken, 514-8507

Other trials in Japan

South Africa6 sites

  • Arthritis Clinical Research Tr /ID# 163855

    Cape Town, Western Cape, 7405

  • Wits Clinical Research Site /ID# 163919

    Johannesburg, Gauteng, 2193

  • Greenacres Hospital /ID# 164190

    Port Elizabeth, Eastern Cape, 6045

  • University of Pretoria /ID# 163852

    Pretoria, Gauteng, 0001

  • Jakaranda Hospital /ID# 164242

    Pretoria, Gauteng, 0002

  • Winelands Medical Research Ctr /ID# 163853

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Turkey (Türkiye)6 sites

  • Bakirkoy Dr. Sadi Konuk Training & Research Hospital /ID# 162517

    Istanbul, 34147

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 163383

    Istanbul, 34899

  • Necmettin Erbakan Universitesi /ID# 163382

    Meram Konya, 42080

  • Sakarya Universitesi Egitim /ID# 163397

    Sakarya, 54100

  • Cukurova Universitesi Tip Fakultesi /ID# 162516

    Saricam Adana, Adana, 01330

  • Hacettepe Universitesi Tip Fak /ID# 162518

    Sihhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

United Kingdom6 sites

  • Christchurch Hospital /ID# 162702

    Christchurch, BH23 2JX

  • UH Coventry & Warwickshire /ID# 162701

    Coventry, CV2 2DX

  • Glasgow Royal Infirmary /ID# 162703

    Glasgow, G4 0SF

  • Whipps Cross Univ Hospital /ID# 161055

    London, London, City of, E11 1NR

  • Guy's and St Thomas' NHS Found /ID# 161065

    London, London, City of, SE1 9RT

  • Luton & Dunstable University Hospital /ID# 162704

    Luton, LU4 0DZ

Other trials in United Kingdom

Chile5 sites

  • M y F Estudios Clínicos Ltda. /ID# 168722

    Ñuñoa, Santiago Metropolitan, 7750495

  • CTR Estudios SpA /ID# 206217

    Providencia, 7500571

  • Centro Inter Estud Clin CIEC /ID# 168725

    Santiago, 8420383

  • Prosalud Ltda. /ID# 169546

    Santiago, ZC:7510047

  • Clinica Dermacross S.A /ID# 168726

    Vitacura Santiago, 7640881

Other trials in Chile

Colombia5 sites

  • Fundacion Centro de Investigac /Id# 168201

    Antioquia, 050022

  • Ctr Int de Reum del Caribe SAS /ID# 164051

    Barranquilla, 80002

  • Centro de Investigacion en Reumatologia CIREEM /ID# 166030

    Bogota, Cundinamarca, 110231

  • Preventive Care Sas /Id# 163781

    Chía, 250001

  • Hospital Pablo Tobon Uribe /ID# 164233

    Medellín

Other trials in Colombia

Czechia5 sites

  • Revmatologie Bruntal, s.r.o /ID# 159636

    Bruntál, 79201

  • Artroscan s.r.o. /ID# 159634

    Ostrava, 722 00

  • Revmatologicka ambulance /ID# 159637

    Prague, Praha 4, 140 00

  • Revmatologicka ambulance /ID# 159671

    Prague, Praha 4, 140 00

  • Medical Plus, s.r.o. /ID# 159635

    Uherské Hradište, 686 01

Other trials in Czechia

Italy5 sites

  • Ospedali Riuniti Universita /ID# 161085

    Ancona, 60023

  • Azienda Ospedaliera Universitaria Policlinico "G. Rodolico - San Marco" /Id# 161084

    Catania, 95123

  • AOU Federico II /ID# 202411

    Naples, Campania, 80131

  • Azienda Unita Sanitaria Locale/IRCCS c/o Arcispedale Santa Maria Nuova /ID# 161090

    Reggio Emilia, Emilia-Romagna, 42123

  • Policlinico Universitario Campus Bio-Medico /ID# 162306

    Rome, Lazio, 00128

Other trials in Italy

New Zealand5 sites

  • North Shore Hospital /ID# 169409

    Auckland, 0622

  • Middlemore Hospital /ID# 166414

    Auckland, 2025

  • Waikato Hospital /ID# 166415

    Hamilton, Waikato Region, 3204

  • Porter Rheumatology Ltd /ID# 200421

    Nelson, 7010

  • Timaru Rheumatology Studies /ID# 166413

    Timaru, 7910

Other trials in New Zealand

Russia5 sites

  • Kazan State Medical University /ID# 164531

    Kazan', Tatarstan, Respublika, 420012

  • Family Outpatient clinic#4 LLC /ID# 164530

    Korolev, Moscow, 141060

  • Moscow S.P.Botkin City Clinica /ID# 164533

    Moscow, 125284

  • LLC Medical Center /ID# 164529

    Novosibirsk, Novosibirsk Oblast, 630099

  • State budgetary institution /ID# 164532

    Saint Petersburg, 192242

Other trials in Russia

Serbia5 sites

  • Institute for Rheumatology /ID# 166217

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 166223

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 166229

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 166231

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 166293

    Belgrade, Beograd, 11000

Other trials in Serbia

Taiwan5 sites

  • China Medical University Hosp /ID# 159402

    Taichung, Taichung, 40447

  • Chung Shan Medical University /ID# 159403

    Taichung, 404

  • National Taiwan University Hospital /ID# 160878

    Taipei, 10002

  • Taipei Veterans General Hosp /ID# 166222

    Taipei, 11217

  • Linkou Chang Gung Memorial Ho /ID# 166221

    Taoyuan City, 33305

Other trials in Taiwan

Australia4 sites

  • Emeritus Research Sydney /ID# 166780

    Botany, New South Wales, 2019

  • Barwon Rheumatology /ID# 166782

    Geelong, Victoria, 3220

  • Heidelberg Repatriation Hospital /ID# 167450

    Heidelberg West, Victoria, 3081

  • The Queen Elizabeth Hospital /ID# 169333

    Woodville, South Australia, 5011

Other trials in Australia

Croatia4 sites

  • Klinicki bolnicki centar Rijeka /ID# 161159

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Poliklinika Repromed /ID# 203555

    Zagreb, City of Zagreb, 10000

  • Medical Center Kuna-Peric /ID# 161160

    Zagreb, 10000

  • Poliklinika Bonifarm /ID# 206662

    Zagreb, 10000

Other trials in Croatia

Latvia4 sites

  • M &M Centrs /Id# 161483

    Adazi, LV2167

  • D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 161488

    Liepāja, 3401

  • Clinic ORTO /ID# 161486

    Riga, 1005

  • P. Stradins Clinical Univ Hosp /ID# 164442

    Riga, LV-1002

Other trials in Latvia

Lithuania4 sites

  • VAKK dr. Kildos Clinic /ID# 167257

    Kaunas, 50128

  • Klaipeda University Hospital /ID# 167258

    Klaipėda, 92288

  • Public Institution Republican /ID# 165155

    Šiauliai, 76231

  • Vilnius University Hospital /ID# 165123

    Vilnius, LT-08661

Other trials in Lithuania

Spain4 sites

  • Hospital Universitario A Coruña - CHUAC /ID# 161129

    A Coruña, A Coruna, 15006

  • Hospital Campus de la Salud /ID# 170760

    Granada, 18016

  • Hospital Universitario Ramon y Cajal /ID# 161130

    Madrid, 28034

  • Hospital Universitario 12 de Octubre /ID# 163198

    Madrid, 28041

Other trials in Spain

Belarus3 sites

  • Brest Regional Hospital /ID# 164535

    Brest, 224027

  • Healthcare Institution /ID# 164536

    Grodno, 230017

  • First City Clinical Hospital /ID# 164534

    Minsk, 220013

Other trials in Belarus

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska /ID# 164503

    Banja Luka, Republika Srpska, 78000

  • University Clinical Hospital Mostar /ID# 165799

    Mostar, 88000

  • Clinical Center University of Sarajevo /ID# 164502

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Estonia3 sites

  • Center of Clinical and Basic Research /ID# 163870

    Tallinn, Harju, 10128

  • East Tallinn Central Hospital /ID# 163790

    Tallinn, 10138

  • MediTrials /ID# 163706

    Tartu, Tartu, 50406

Other trials in Estonia

Hong Kong3 sites

  • Prince of Wales Hospital /ID# 163506

    Hong Kong, 999077

  • Queen Mary Hospital /ID# 162492

    Hong Kong, 999077

  • Tuen Mun Hospital /ID# 162493

    Tuenmen, 999077

Other trials in Hong Kong

Israel3 sites

  • The Lady Davis Carmel MC /ID# 170262

    Haifa, 3436212

  • Sheba Medical Center /ID# 202532

    Ramat Gan, 5239424

  • Tel Aviv Sourasky Medical Center /ID# 169845

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Mexico3 sites

  • Invest y Biomed de Chihuahua /ID# 164007

    Chihuahua City, 31000

  • Instituto Jalisciense de Metabolismo SC /ID# 164005

    Guadalajara, Jalisco, 44670

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 164006

    Mexico City, Mexico City, 11850

Other trials in Mexico

Netherlands3 sites

  • Medisch Centrum Leeuwarden /ID# 161575

    Leeuwarden, 8934 AD

  • Erasmus Medisch Centrum /ID# 161092

    Rotterdam, 3015 CE

  • Maasstad Ziekenhuis /ID# 160168

    Rotterdam, 3079 DZ

Other trials in Netherlands

Puerto Rico3 sites

  • Cruz-Santana, Carolina, PR /ID# 163307

    Carolina, 00985

  • Ponce Medical School Foundation /ID# 163920

    Ponce, 00716-0377

  • GCM Medical Group, PSC /ID# 162160

    San Juan, 00917

Other trials in Puerto Rico

Slovakia3 sites

  • MEDMAN s.r.o. /ID# 165892

    Martin, 036 01

  • Reumatologická ambulancia Reum.hapi s.r.o. /ID# 166486

    Nové Mesto nad Váhom, 915 01

  • Slovak research center Team Member, Thermium s.r.o. /ID# 166489

    Pieštany, 921 01

Other trials in Slovakia

Slovenia3 sites

  • Univ Medical Ctr Ljubljana /ID# 164212

    Ljubljana, 1000

  • University Medical Ctr Maribor /ID# 169260

    Maribor, 2000

  • General Hospital Murska Sobota /ID# 164211

    Murska Sobota, 9000

Other trials in Slovenia

Ireland2 sites

  • St Vincent's University Hosp /ID# 161073

    Dublin, D04 T6F4

  • Croom Orthopaedic Hospital /ID# 164998

    Limerick, V35 F434

Other trials in Ireland

Malaysia2 sites

  • Hospital Raja Permaisuri Bainun /ID# 161099

    Ipoh, Perak, 30450

  • Hospital Tuanku Ja afar /ID# 161096

    Seremban, 70300

Other trials in Malaysia

Norway2 sites

  • Helse Forde /ID# 167853

    Førde, Sogn Og Fjordane, 6812

  • St. Olavs Hospital HF /ID# 163321

    Trondheim, Sor-Trondelag, 7006

Other trials in Norway

Singapore2 sites

  • Singapore General Hospital /ID# 161094

    Singapore, Central Singapore, 169068

  • Tan Tock Seng Hospital /ID# 161095

    Singapore, 308433

Other trials in Singapore

South Korea2 sites

  • Inha University Hospital /ID# 163890

    Junggu, Incheon Gwang Yeogsi, 22332

  • Ajou University Hospital /ID# 163891

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Switzerland2 sites

  • HFR Fribourg - Hopital Canton /ID# 162090

    Fribourg, 1708

  • Kantonsspital St. Gallen /ID# 158131

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Belgium1 site

  • Reuma clinic /ID# 164243

    Genk, 3600

Other trials in Belgium

About this study

Official title: A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression.

The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

Read the detailed description

The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 5 years (Period 2), a 30-day follow-up call or visit, and a 70-day follow-up call.

Period 1 includes 24 weeks of randomized, double-blind, placebo-controlled and active comparator-controlled treatment followed by 32 weeks of active comparator-controlled upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.

Participants who meet eligibility criteria will be randomized in a 2:2:2:1:1 ratio to one of five treatment groups:

  • Group 1: Upadacitinib 15 mg QD
  • Group 2: Upadacitinib 30 mg QD
  • Group 3: Adalimumab 40 mg every other week (EOW)
  • Group 4: Placebo followed by upadacitinib 15 mg QD
  • Group 5: Placebo followed by upadacitinib 30 mg QD

Randomization will be stratified by extent of psoriasis (≥ 3% body surface area [BSA] or < 3% BSA), current use of at least 1 non-biologic DMARD, presence of dactylitis, and presence of enthesitis, except for participants from China and Japan, where randomization for each country will be stratified by extent of psoriasis (≥ 3% BSA or < 3% BSA) only.

Participants who complete the Week 56 visit (end of Period 1) will enter the long-term extension portion of the study, Period 2 (total treatment up to approximately 5 years), and continue study treatment as assigned in Period 1 in a blinded manner until the last subject completes the last visit of Period 1 (Week 56), when study drug assignment in both periods will be unblinded and participants will be dispensed study drug in an open-label fashion until the completion of Period 2.

At Week 16, rescue therapy will be offered to participants classified as non-responders (defined as not achieving at least 20% improvement in tender joint count (TJC) and / or swollen joint count (SJC) at both Week 12 and Week 16). Starting at Week 36, participants who fail to demonstrate at least 20% improvement in either or both TJC and SJC compared to Baseline at 2 consecutive visits will be discontinued from study drug treatment. Additionally, in participants continuing on study drug, starting at the Week 36 visit, initiation of or change in background PsA medication(s) is allowed as per local label.

Being tested
Adalimumab, Upadacitinib, Placebo to Upadacitinib, Placebo to Adalimumab
Keywords
Arthritis, Psoriasis, Anti-inflammatory, Joint disease, Musculoskeletal disease, Anti-Rheumatic
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.

  • AdalimumabDrug

    Also called Humira®

    Administered by subcutaneous injection

  • UpadacitinibDrug

    Also called ABT 494, RINVOQ®

    Oral tablet

  • Placebo to UpadacitinibDrug

    Oral tablet

  • Placebo to AdalimumabDrug

    Administered by subcutaneous injection

Study groups in NCT03104400
Study groupRoleWhat they receive
Upadacitinib 15 mgExperimentalPeriod 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Receives: Drug: Upadacitinib; Drug: Placebo to Adalimumab
Upadacitinib 30 mgExperimentalPeriod 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Receives: Drug: Upadacitinib; Drug: Placebo to Adalimumab
AdalimumabActive comparatorPeriod 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks. Period 2: Participants continue to receive adalimumab 40 mg every other week.
Receives: Drug: Adalimumab; Drug: Placebo to Upadacitinib
Placebo / Upadacitinib 15 mgPlacebo comparatorPeriod 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Receives: Drug: Upadacitinib; Drug: Placebo to Upadacitinib; Drug: Placebo to Adalimumab
Placebo / Upadacitinib 30 mgPlacebo comparatorPeriod 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks. Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Receives: Drug: Upadacitinib; Drug: Placebo to Upadacitinib; Drug: Placebo to Adalimumab

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 (17)

  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, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%.

    Measured: Baseline and Week 16

  4. Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24

    The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.

    Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).

    Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).

    Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.

    The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage.

    Measured: Baseline and Week 24

  5. 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

  6. Percentage of Participants With Resolution of Enthesitis at Week 24

    Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

    LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).

    Measured: Week 24

  7. Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab

    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

  8. 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

  9. 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

  10. Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab

    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

  11. Percentage of Participants With Resolution of Dactylitis at Week 24

    Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

    The Leeds Dactylitis Index (LDI) is a score based on finger circumference and tenderness, assessed and summed across all dactylitic digits (fingers and toes). The presence of a dactylitic digit is defined as at least one affected AND tender digit with circumference increase over reference digit ≥ 10%. The reference digit circumference is either the contralateral digit (unaffected digit on opposite hand or foot) if available, or from a standard reference table if otherwise. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst].

    The ratio of circumference between an affected digit and reference digit is multiplied by the tenderness score for each affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.

    Measured: Week 24

  12. Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab

    Participants were asked to indicate the severity of their arthritis pain within the previous week on a numerical rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 12

  13. Change From Baseline in HAQ-DI - Superiority Versus Adalimumab

    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

  14. Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire 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

  15. 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

  16. 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

  17. 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 start27 Apr 2017
  3. Primary completion26 Sep 2019
  4. Study completion9 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
1,705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03104400
Sponsor's protocol ID
M15-572
Other IDs
2016-004130-24, 2016
Acronym
SELECT - PsA 1
Status last verified
Sep 2025
First submitted
4 Apr 2017
Last updated
22 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Coates LC, Lagunes I, Liu Y, Mancl E, Parikh B, Philips C. Long-Term Safety and Efficacy of Upadacitinib in Patients with Psoriatic Arthritis: 5-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2026 Oct 7. doi: 10.1007/s40744-026-00884-9. Online ahead of print.

    PubMed 42844553

  • 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

  • Baraliakos X, Ranza R, Ostor A, Ciccia F, Coates LC, Rednic S, Walsh JA, Douglas K, Gao T, Kato K, Song IH, Ganz F, Deodhar A. Efficacy and safety of upadacitinib in patients with active psoriatic arthritis and axial involvement: results from two phase 3 studies. Arthritis Res Ther. 2023 Apr 10;25(1):56. doi: 10.1186/s13075-023-03027-5.

    PubMed 37038159

  • 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

  • McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Chen L, Duan Y, Liu J, Lippe R, Wung P. Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2023 Feb;10(1):275-292. doi: 10.1007/s40744-022-00499-w. Epub 2022 Oct 15.

    PubMed 36243812

  • 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, Mease PJ, Soriano ER, Kishimoto M, Salvarani C, Saffore CD, Zueger P, McDearmon-Blondell E, Kato K, Gladman DD. Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Rheumatol Ther. 2021 Dec;8(4):1789-1808. doi: 10.1007/s40744-021-00379-9. Epub 2021 Oct 12.

    PubMed 34636026

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and Upadacitinib in people with Psoriatic Arthritis, run by AbbVie at 345 sites in 46 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 11 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 22 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 345 sites in United States, China, Poland, Brazil, Ukraine and 41 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 NCT03104400, which also lists 16 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 22 Sep 2025.

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