AzTrials
AzTrials

Rheumatoid ArthritisPhase 3SELECT-COMPARENCT02629159

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

A Phase 3 study testing Adalimumab and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 370 sites in 44 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Adalimumab and Upadacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,629 participants
Where
370 sitesin 44 countries
Study dates
1 Dec 2015to 30 Sep 2027
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

  • Adult male or female, at least 18 years old.
  • Diagnosis of RA for greater than or equal to 3 months.
  • Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
  • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
  • At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
  • Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
  • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

Who cannot join

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
  • Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
  • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Trial locations and contacts

370 sites in 44 countries.

370 sites in 44 countries

United States109 sites

  • Albuquerque Clinical Trials, Inc /ID# 143083

    Albuquerque, New Mexico, 87102

  • Arthritis Clinic of N. VA, P.C /ID# 143109

    Arlington, Virginia, 22205

  • Arthritis and Rheumatology /ID# 155668

    Atlanta, Georgia, 30342

  • Austin Regional Clinic /ID# 143084

    Austin, Texas, 78731

  • AARDS Research, Inc. /ID# 154190

    Aventura, Florida, 33180

  • Diagnostic Group Integrated He /ID# 148356

    Beaumont, Texas, 77701

  • Osteoporosis Medical Center /ID# 153935

    Beverly Hills, California, 90211

  • Achieve Clinical Research, LLC /ID# 143136

    Birmingham, Alabama, 35216

  • ZASA Clinical Research /ID# 143134

    Boynton Beach, Florida, 33472

  • Joint & Muscle Research Instit /ID# 143119

    Charlotte, North Carolina, 28204

  • DJL Clinical Research, PLLC /ID# 143101

    Charlotte, North Carolina, 28210-8508

  • Ctr for Arth and Rheum Disease /ID# 143113

    Chesapeake, Virginia, 23320

  • Great Lakes Clinical Trials /ID# 148357

    Chicago, Illinois, 60640

  • Clinical Res of West FL, Inc. /ID# 143112

    Clearwater, Florida, 33765

  • Arthritis Assoc & Osteo Ctr /ID# 143122

    Colorado Springs, Colorado, 80920

  • Columbia Arthritis Center /ID# 153730

    Columbia, South Carolina, 29204

  • Arthritis Care and Diagnostic /ID# 150677

    Dallas, Texas, 75231

  • Metroplex Clinical Research /ID# 145631

    Dallas, Texas, 75231

  • Clinical Research Solutions, LLC /ID# 154619

    Dayton, Ohio, 45409

  • International Medical Research /ID# 143132

    Daytona Beach, Florida, 32117

  • St. Luke's Hospital /ID# 156750

    Duluth, Minnesota, 55805

  • Altoona Ctr Clinical Res /ID# 143110

    Duncansville, Pennsylvania, 16635

  • EmergeOrtho, P.A. /ID# 143100

    Durham, North Carolina, 27704

  • Doctor's Hosp at Renaissance /ID# 154616

    Edinburg, Texas, 78539

  • MedResearch Inc. /ID# 154618

    El Paso, Texas, 79935

  • T. Joseph Raoof, MD, Inc. /ID# 144884

    Encino, California, 91436

  • Rheumatology Ctr of San Diego /ID# 153747

    Escondido, California, 92025

  • Arthritis and Rheum Clin N. CO /ID# 156094

    Fort Collins, Colorado, 80528

  • Rheumatology and Immunotherapy Center /ID# 145646

    Franklin, Wisconsin, 53132

  • Arthritis Treatment Center /ID# 155260

    Frederick, Maryland, 21204

  • Arthritis Center of North GA /ID# 155258

    Gainesville, Georgia, 30501

  • Innovative Clinical Research /ID# 145637

    Greenville, South Carolina, 29601

  • C.V. Mehta MD, Med Corporation /ID# 143116

    Hemet, California, 92543

  • Accurate Clinical Management /ID# 145644

    Houston, Texas, 77004

  • Accurate Clinical Research /ID# 145645

    Houston, Texas, 77034

  • Rheumatology Clinic of Houston /ID# 150921

    Houston, Texas, 77065

  • Houston Institute for Clin Res /ID# 144879

    Houston, Texas, 77074

  • Pioneer Research Solutions, Inc. /ID# 145640

    Houston, Texas, 77098-5294

  • Arthritis Consultants, P.A. /ID# 144880

    Killeen, Texas, 76549

  • Arthritis Associates, PLLC /ID# 155490

    Kingsport, Tennessee, 37660

  • Rheumatology Consultants, PLLC /ID# 153731

    Knoxville, Tennessee, 37909

  • Allergy and Rheum Med Clin /ID# 146083

    La Jolla, California, 92037

  • Kotha and Kotha /ID# 161046

    La Mesa, California, 91942

  • TriWest Research Associates- La Mesa /ID# 143115

    La Mesa, California, 91942

  • Advanced Rheumatology, PC /ID# 143118

    Lansing, Michigan, 48910

  • Arthritis and Osteo Assoc /ID# 143127

    Las Cruces, New Mexico, 88011

  • North Georgia Rheumatology Grp /ID# 147170

    Lawrenceville, Georgia, 30045

  • Cape Fear Arthritis Care /ID# 148361

    Leland, North Carolina, 28451

  • Physician Res. Collaboration /ID# 143087

    Lincoln, Nebraska, 68516

  • Valerius Med Grp & Res Ctr /ID# 143120

    Los Alamitos, California, 90720-5402

  • Discovery MM Services, Inc /ID# 163504

    Los Angeles, California, 11373

  • Arthritis & Osteoporosis Assoc /ID# 147364

    Lubbock, Texas, 79424

  • P&I Clinical Research /ID# 161625

    Lufkin, Texas, 75904-3132

  • Dr. Ramesh Gupta /ID# 143099

    Memphis, Tennessee, 38119

  • Advanced Clinical Research /ID# 153090

    Meridian, Idaho, 83642

  • AZ Arthritis and Rheum Assoc /ID# 143130

    Mesa, Arizona, 85202

  • SW Rheumatology Res. LLC /ID# 143126

    Mesquite, Texas, 75150

  • Lakes Research, LLC /ID# 145630

    Miami, Florida, 33014

  • FL Med Ctr and Research, Inc. /ID# 143081

    Miami, Florida, 33142

  • Ctr Arthritis & Rheumatic Dise /ID# 143135

    Miami, Florida, 33173

  • Precision Research Org, LLC /ID# 143092

    Miami Lakes, Florida, 33016-1501

  • Discovery MM Services, Inc. /ID# 162578

    Missouri City, Texas, 77459-4750

  • Discovery MM Services, Inc. /ID# 163183

    Missouri City, Texas, 77459-4750

  • Discovery MM Services, Inc. /ID# 163184

    Missouri City, Texas, 77459-4750

  • Coastal Carolina Health Care /ID# 148359

    New Bern, North Carolina, 28562

  • Advanced Clin Res of Orlando /ID# 154617

    Ocoee, Florida, 34761-4547

  • Quality Clinical Research Inc. /ID# 156394

    Omaha, Nebraska, 68114

  • Rheum Assoc of Central FL /ID# 145632

    Orlando, Florida, 32806

  • Omega Research Consultants /ID# 145635

    Orlando, Florida, 32810

  • HMD Research LLC /ID# 163292

    Orlando, Florida, 32819

  • Desert Medical Advances /ID# 143097

    Palm Desert, California, 92260

  • Arthritis Research of Florida /ID# 143125

    Palm Harbor, Florida, 34684-2672

  • Arthritis Center, Inc. /ID# 145647

    Palm Harbor, Florida, 34684

  • SunValley Arthritis Center, Lt /ID# 143123

    Peoria, Arizona, 85381

  • Elite Clinical Studies, LLC /ID# 144881

    Phoenix, Arizona, 85018

  • AZ Arthritis and Rheum Researc /ID# 143080

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis and Rheum Researc /ID# 143121

    Phoenix, Arizona, 85032-9306

  • AZ Arthritis & Rheuma Research /ID# 143131

    Phoenix, Arizona, 85032

  • Arizona Research Center, Inc. /ID# 144877

    Phoenix, Arizona, 85053-4061

  • St. Lawrence Health System /ID# 161619

    Potsdam, New York, 13676

  • Shanahan Rheuma & Immuno /ID# 145643

    Raleigh, North Carolina, 27617

  • Sierra Rheumatology /ID# 155672

    Roseville, California, 95661

  • Shores Rheumatology, PC /ID# 162977

    Saint Clair Shores, Michigan, 48081

  • Sun Research Institute /ID# 159539

    San Antonio, Texas, 78215

  • Accurate Clinical Management /ID# 143089

    San Antonio, Texas, 78229

  • Arthritis & Osteo Ctr of S. TX /ID# 143103

    San Antonio, Texas, 78232

  • West Virginia Research Inst /ID# 153088

    South Charleston, West Virginia, 25309

  • Arthritis Northwest, PLLC /ID# 143088

    Spokane, Washington, 99204

  • St. Anthony Comprehsve Res Ins /ID# 143095

    St. Petersburg, Florida, 33705

  • Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 143091

    Summerville, South Carolina, 29486-7887

  • AZ Arthritis & Rheum Research /ID# 156093

    Sun City, Arizona, 85351

  • Clinical Research West FL /ID# 148358

    Tampa, Florida, 33603

  • SW FL Clin Res Ctr, Tampa, FL /ID# 143117

    Tampa, Florida, 33609

  • BayCare Medical Group, Inc. /ID# 143085

    Tampa, Florida, 33614-7101

  • Arthritis Assoc of NW Ohio /ID# 143094

    Toledo, Ohio, 43606

  • DM Clinical Research /ID# 151357

    Tomball, Texas, 77375

  • Atlantic Coast Research /ID# 148355

    Toms River, New Jersey, 08755

  • Ocean Rheumatology, PA /ID# 143111

    Toms River, New Jersey, 08755

  • University of Arizona Cancer Center - North Campus /ID# 143114

    Tucson, Arizona, 85719-1478

  • Healthcare Research Consultant /ID# 143129

    Tulsa, Oklahoma, 74135

  • North Mississippi Med Clinics /ID# 145636

    Tupelo, Mississippi, 38801

  • Robin K. Dore MD, Inc /ID# 143090

    Tustin, California, 92780

  • The Vancouver Clinic, INC. PS /ID# 143107

    Vancouver, Washington, 98664

  • Lovelace Scientific Resources /ID# 143106

    Venice, Florida, 34292

  • Arthritis Rheumatic Back Disorder /ID# 143102

    Voorhees Township, New Jersey, 08043

  • The Center for Rheumatology & /ID# 151356

    Wheaton, Maryland, 20902

  • Medvin Clinical Research /ID# 148362

    Whittier, California, 90606

  • Clinical Pharmacology Study Gr /ID# 143082

    Worcester, Massachusetts, 01605

  • Clinical Research Ctr Reading /ID# 143133

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Russia17 sites

  • Сity Clinical Hospital #4 /ID# 143023

    Ivanovo, 153005

  • Kazan State Medical University /ID# 144871

    Kazan', Tatarstan, Respublika, 420012

  • Family Outpatient clinic#4,LLC /ID# 148319

    Korolev, Moscow, 141060

  • Clinical Hospital No.1 n.a. N.I.Pirogov /ID# 143138

    Moscow, Moscow, 119049

  • Russian National Research Medi /ID# 143028

    Moscow, 117997

  • City Clinical Hospital Botkina /ID# 145628

    Moscow, 125284

  • Moscow State Univ Med and Dent /ID# 145623

    Moscow, 127473

  • City Clinical Hospital #5 /ID# 148318

    Nizhny Novgorod, 603005

  • Orenburg State Medical Academy /ID# 143018

    Orenburg, 460000

  • Perm Clinical Center of FMBA /ID# 145627

    Perm, Permskiy Kray, 614109

  • LLC Novaya Klinika /ID# 143019

    Pyatigorsk, Stavropol Kray, 357500

  • Ryazan State Medical Universit /ID# 143031

    Ryazan, 390026

  • II Dzhan Research Center /ID# 143027

    Saint Petersburg, 192242

  • NW State Med Univ NA Mechnikov /ID# 143022

    Saint Petersburg, 193015

  • Tver Regional Clinical Hosp. /ID# 143026

    Tver', Tver Oblast, 170036

  • Republican clinical hospital n /ID# 145626

    Ufa, 450005

  • Ulyanovsk Regional Clin Hosp /ID# 143030

    Ulyanovsk, 432018

Other trials in Russia

Poland16 sites

  • Osteo-Medic spolka cywilna /ID# 143006

    Bialystok, Podlaskie Voivodeship, 15-351

  • ClinicMed Badurski i wspolnicy SJ /ID# 163300

    Bialystok, 15-879

  • Malopolskie Centrum Kliniczne /ID# 152782

    Cracow, Lesser Poland Voivodeship, 30-149

  • Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163293

    Gdynia, Pomeranian Voivodeship, 81-384

  • Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163294

    Gdynia, Pomeranian Voivodeship, 81-384

  • Synexus Polska Sp. z o.o. Oddz. Poznan /ID# 163295

    Gdynia, Pomeranian Voivodeship, 81-384

  • McBk Sc /Id# 143003

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • Silmedic Sp z o.o /ID# 152914

    Katowice, Silesian Voivodeship, 40-282

  • Pratia MCM Krakow /ID# 143005

    Krakow, Lesser Poland Voivodeship, 30-510

  • REUMED Sp.z o.o. Filia nr 1 /ID# 148189

    Lublin, Lublin Voivodeship, 20-607

  • Solumed Sp. zoo Cent Medyczne /ID# 152783

    Poznan, 60-425

  • NZOZ Nasz Lekarz /ID# 143004

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 151960

    Warsaw, Masovian Voivodeship, 02-507

  • Centrum Medyczne AMED Warszawa Targowek /ID# 157621

    Warsaw, Masovian Voivodeship, 03-291

  • Rheuma Medicus /ID# 143007

    Warsaw, 02-118

  • WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 145622

    Wroclaw, Lower Silesian Voivodeship, 51-685

Other trials in Poland

Argentina14 sites

  • Mautalen Salud e Investigacion /ID# 142843

    Buenos Aires, 1128

  • Fundacion Sanatorio Guemes /ID# 148405

    Buenos Aires, 1180

  • Consultorio Reumatologic Pampa /ID# 144853

    Buenos Aires, 1428

  • Cemic /Id# 148404

    Buenos Aires, 1431

  • Org Medica de Investigacion /ID# 144855

    Buenos Aires, C1015ABO

  • Aprillus Asistencia e Investig /ID# 148406

    Capital Federal, Buenos Aires, 1046

  • Inst. Rheumatologic Strusberg /ID# 145601

    Córdoba, 5000

  • Consultora Integral de Salud S /ID# 144856

    Córdoba, 5900

  • Instituto CAICI /ID# 144854

    Rosario, Santa FE, 2000

  • Cordis S.A. /Id# 152622

    Salta, 4400

  • Iari /Id# 151293

    San Fernando, 1646

  • Centro Integral de Reumatologi /ID# 142845

    San Miguel de Tucumán, 4000

  • Centro Medico Privado/Reuma /ID# 142842

    San Miguel de Tucumán, 4000

  • Centro de Enfermedades /ID# 153542

    Santa Fe, 2000

Other trials in Argentina

Chile12 sites

  • Reg. Clinical Hosptial Concepcion /ID# 151271

    Concepción, 4070038

  • Corp de Beneficencia Osorno /ID# 147941

    Osorno, 1710216

  • Someal /Id# 144704

    Providencia-santiago, 7510186

  • Quantum Research LTDA. /ID# 142893

    Puerto Varas, 5550170

  • Quantum Research Stgo. /ID# 157933

    Santiago, 7500588

  • Soc. de Prestaciones medicas y Paramedicas Goecke /ID# 142890

    Santiago, 7510047

  • Clinica DermaCross /ID# 142892

    Santiago, 7640881

  • Investigaciones Medicas SSMSO /ID# 151686

    Santiago, 8207257

  • Centro Inter Estud Clin CIEC /ID# 144777

    Santiago, 8420383

  • Ctr de Inv Clinica del Sur /ID# 142888

    Temuco, Araucania, 4781156

  • Centro Medico de Reumatologia /ID# 148402

    Temuco, 4790928

  • Cinvec /Id# 144705

    Viña del Mar, 2520997

Other trials in Chile

Czechia11 sites

  • REVMACLINIC s.r.o. /ID# 142906

    Brno, 611 41

  • Revmatologie Bruntal, s.r.o /ID# 142903

    Bruntál, 79201

  • L.K.N. Arthrocentrum, s.r.o /ID# 145961

    Hlučín, Moravian-Silesian Region, 748 01

  • Revmatologicka a interni ambul /ID# 142907

    Kladno, 272 01

  • CTCenter MaVe, s.r.o. /ID# 142905

    Olomouc, Olomouc Region, 779 00

  • Revmatologie MUDr. Klara Sirov /ID# 142908

    Ostrava, 702 00

  • Arthromed, s.r.o. /ID# 144706

    Pardubice, 530 02

  • Revmatologicky ustav Praha /ID# 142904

    Prague, Praha 2, 128 00

  • Nuselská poliklinika, Revmatologie /ID# 144862

    Prague, Praha 4, 140 00

  • Revmatologická ambulance /ID# 145963

    Prague, Praha 4, 140 00

  • Thomayerova nemocnice /ID# 145962

    Prague, Praha 4, 140 00

Other trials in Czechia

Hungary11 sites

  • Budai Irgalmasrendi Korhaz /ID# 142952

    Budapest, 1023

  • Revita Reumatologiai Rendelo /ID# 142950

    Budapest, 1027

  • Synexus Magyarorszag Kft. /ID# 153061

    Budapest, 1036

  • Qualiclinic Kft. /ID# 142953

    Budapest III, Pest County, 1036

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142948

    Debrecen, 4031

  • Hevizgyogyfurdo es Szent Andra /ID# 142949

    Hévíz, 8380

  • Kiskunhalasi Semmelweis Korhaz /ID# 151944

    Kiskunhalas, 6400

  • Pest Megyei Flor Ferenc Korhaz /ID# 142954

    Kistarcsa, 2143

  • CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 142951

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Markusovszky Egyetemi Oktatókórház /ID# 145621

    Szombathely, Vas County, 9700

  • Vital Medical Center Orvosi es /ID# 145950

    Veszprém, Veszprém megye, 8200

Other trials in Hungary

France10 sites

  • CHU Bordeaux-Hopital Pellegrin /ID# 145618

    Bordeaux, 33076

  • Hopital de la Cote de Nacre /ID# 145616

    Caen, 14033

  • CHU Gabriel Montpied /ID# 145619

    Clermont-Ferrand, 63000

  • CHRU Lille - Hôpital Claude Huriez /ID# 151312

    Lille, Hauts-de-France, 59045

  • Hopital de la Conception /ID# 142926

    Marseille, 13005

  • Hopital Saint Eloi /ID# 142925

    Montpellier, Herault, 34295

  • Hopital Pitie Salpetriere /ID# 145605

    Paris, 75651

  • CHU de Rennes - Hospital Sud /ID# 151957

    Rennes, 35203

  • CHU Strasbourg Hautepierre Hos /ID# 144708

    Strasbourg, 67200

  • Hopital Universitaire Purpan /ID# 144707

    Toulouse, Haute-Garonne, 31059

Other trials in France

South Africa10 sites

  • Synexus Helderberg Clinical Tr /ID# 148322

    Cape Town, Western Cape, 7130

  • Arthritis Clinical Research Tr /ID# 144874

    Cape Town, Western Cape, 7405

  • Tiervlei Trial Centre /ID# 153085

    Cape Town, Western Cape, 7530

  • St. Augustine's Hospital /ID# 143047

    Durban, KwaZulu-Natal, 4001

  • Wits Clinical Research Site /ID# 148320

    Johannesburg, Gauteng, 2193

  • Greenacres Hospital /ID# 144710

    Port Elizabeth, Eastern Cape, 6045

  • University of Pretoria /ID# 148353

    Pretoria, Gauteng, 0001

  • Jakaranda Hosp, Emmed Research /ID# 143046

    Pretoria, Gauteng, 0132

  • Jakaranda Hosp, Emmed Research /ID# 145968

    Pretoria, Gauteng, 0132

  • Winelands Medical Research Ctr /ID# 143048

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Slovakia9 sites

  • MEDMAN s.r.o. /ID# 143045

    Martin, 036 01

  • Reumatologická ambulancia Reum.hapi s.r.o. /ID# 147169

    Nové Mesto nad Váhom, 915 01

  • REUMACENTRUM s.r.o. /ID# 143041

    Partizánske, 958 01

  • Slovak research center Team Member, Thermium s.r.o. /ID# 147614

    Pieštany, 921 01

  • Reumex, s.r.o. /ID# 143043

    Rimavská Sobota, 97 101

  • Reumatologicka ambulancia /ID# 144873

    Sabinov, 083 01

  • TIMMED spol. s r.o. /ID# 144872

    Stará Lubovna, 06401

  • Reumatologicka ambulancia, LER /ID# 143044

    Topoľčany, 955 01

  • ALBAMED s.r.o. /ID# 143042

    Zvolen, 960 01

Other trials in Slovakia

South Korea9 sites

  • Kyungpook National Univ Hosp /ID# 162073

    Daegu, Daegu Gwang Yeogsi, 41944

  • Daegu Catholic University Med /ID# 142973

    Daegu, 705-718

  • Chonnam National University Hospital /ID# 142975

    Gwangju, Jeonranamdo, 61469

  • Chungnam National University Hospital /ID# 142977

    Junggu, Daejeon Gwang Yeogsi, 35015

  • Inha University Hospital /ID# 150886

    Junggu, Incheon Gwang Yeogsi, 22332

  • Hanyang University Seoul Hospi /ID# 142979

    Seongdong-gu, Seoul Teugbyeolsi, 04763

  • Cath Univ Seoul St Mary's Hosp /ID# 142976

    Seoul, Seoul Teugbyeolsi, 06591

  • Seoul National University Hospital /ID# 142978

    Seoul, 03080

  • Asan Medical Center /ID# 142974

    Seoul, 05505

Other trials in South Korea

Taiwan8 sites

  • Kaohsiung Medical University /ID# 143059

    Kaohsiung City, 80708

  • Kaohsiung Chang Gung Memorial Hospital /ID# 143055

    Kaohsiung City, 833

  • Far Eastern Memorial Hospital /ID# 143061

    New Taipei City, 22060

  • China Medical University Hosp /ID# 143058

    Taichung, Taichung, 40447

  • Chung Shan Medical University /ID# 143060

    Taichung, 40201

  • Taipei Veterans General Hosp /ID# 157940

    Taipei, 11217

  • National Taiwan Univ Hosp /ID# 143056

    Taipei City, Taipei, 10002

  • Linkou Chang Gung Memorial Ho /ID# 143057

    Taoyuan City, 33305

Other trials in Taiwan

Ukraine8 sites

  • Regional Clinical Hospital /ID# 152025

    Ivano-Frankivsk, 76018

  • LLC Revmocentr /ID# 143067

    Kiev, Kyiv Oblast, 04070

  • NSC-Strazhesko Ist Cardiology /ID# 152030

    Kiev, 03680

  • Lviv Regional Clinical Hospita /ID# 154450

    Lviv, Lviv Oblast, 79013

  • Lviv Municipal City Clinical /ID# 143068

    Lviv, 79007

  • Odessa National Medical Univ /ID# 143072

    Odesa, 65026

  • Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrogov /ID# 143071

    Vinnytsia, Vinnytsia Oblast, 21018

  • Zaporizhzhia Regional Clinical /ID# 143069

    Zaporizhia, 69600

Other trials in Ukraine

Brazil7 sites

  • Hc Ufmg /Id# 142868

    Belo Horizonte, Minas Gerais, 30130-100

  • Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 142871

    Curitiba, Paraná, 80030-110

  • CIP - Centro Internacional de Pesquisa /ID# 142872

    Goiânia, Goiás, 74110-120

  • Hospital de Clinicas de Porto Alegre /ID# 142870

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 142869

    Porto Alegre, Rio Grande do Sul, 90480-000

  • CCBR Brasil /ID# 150918

    Rio de Janeiro, 22271-100

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 142867

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

Romania7 sites

  • Spitalul Clinic Dr. I. Cantacuzino /ID# 143012

    Bucharest, Bucharest, 020475

  • Spitalul Clinic Dr. I. Cantacuzino /ID# 143017

    Bucharest, Bucharest, 020475

  • Spitalul Clinic Sf. Maria /ID# 144868

    Bucharest, 011172

  • Spitalul Clinic Sf. Maria /ID# 144869

    Bucharest, 011172

  • Spitalul Clinic Sf. Maria /ID# 145966

    Bucharest, 011172

  • Spitalul Clinic de Recuperare /ID# 144867

    Iași, 700656

  • Ecomed SRL /ID# 144870

    Oradea, 410028

Other trials in Romania

Canada6 sites

  • Adachi Medicine Prof. Corp /ID# 154205

    Hamilton, Ontario, L8N 1Y2

  • Groupe de Recherche en Maladies Osseuses /ID# 142878

    Sainte-Foy, Quebec, G1V 3M7

  • St. Clare's Mercy Hospital /ID# 142879

    St. John's, Newfoundland and Labrador, A1C 5B8

  • CA Ctr for Clin Trials CCCT /ID# 157379

    Thornhill, Ontario, L4J 1W3

  • Manitoba Clinic /ID# 161434

    Winnipeg, Manitoba, R3A IM3

  • Ciads /Id# 142880

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Colombia6 sites

  • Ctr Int de Reum del Caribe SAS /ID# 142894

    Barranquilla, 80002

  • Centro de Investigacion en Reumatologia y Especialidades Medicas- CIREEM SAS /ID# 142898

    Bogota, Cundinamarca, 110221

  • Riesgo de Fractura S.A - CAYRE /ID# 142896

    Bogotá, 110221

  • Fund Inst de Reum F. Chalem /ID# 149847

    Bogota DC

  • Medicity S.A.S. /ID# 144860

    Bucaramanga, 680003

  • Centro Integral de Reumatologi /ID# 142897

    Medellín, 50021

Other trials in Colombia

Germany6 sites

  • Med Versorgungszentrum AGILOME /ID# 154975

    Chemnitz, 9126

  • Uniklinik Koln /ID# 145964

    Cologne, North Rhine-Westphalia, 50937

  • Rheumaforschungszentrum II /ID# 142930

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 145620

    Herne, North Rhine-Westphalia, 44649

  • LMU Klinikum der Universität München /ID# 142931

    Munich, 80337

  • Praxis Walter, Rendsburg /ID# 142932

    Rendsburg, Schleswig-Holstein, 24768

Other trials in Germany

Mexico6 sites

  • Invest y Biomed de Chihuahua /ID# 142996

    Chihuahua City, 31000

  • Clinstile, S.A. de C.V. /ID# 144866

    Cuauhtémoc, Mexico City, 06700

  • Centro Peninsular de Investiga /ID# 148159

    Mérida, 97000

  • RM Pharma Specialists, S.A de C.V /ID# 142994

    Mexico City, 03100

  • Hospital de Jesús Nazareno /ID# 142993

    Mexico City, 06090

  • Hosp. Univ. Dr. Jose E. Gonz /ID# 142992

    Monterrey, Nuevo León, 64320

Other trials in Mexico

Portugal6 sites

  • CCA Braga - Hospital de Braga /ID# 148317

    Braga, 4710-243

  • Instituto Portugues De Reumatologia /ID# 148316

    Lisbon, Lisbon District, 1050-034

  • Hospital CUF Descobertas /ID# 160539

    Lisbon, 1998-018

  • Centro Hospitalar de Sao Joao, EPE /ID# 152871

    Porto, 4200-319

  • Unidade Local De Saude Do Alto Minho /ID# 143009

    Viana do Castelo, 4901-858

  • Centro Hospitalar De Vila Nova /ID# 143010

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

Serbia6 sites

  • Institute for Rheumatology /ID# 143032

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 143035

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 143036

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 143037

    Belgrade, Beograd, 11000

  • Special Hospital for Rheuma /ID# 143034

    Novi Sad, Vojvodina, 21101

  • Clinical Center of Vojvodina /ID# 143033

    Novi Sad, Vojvodina, 21137

Other trials in Serbia

Belgium5 sites

  • Rhumaconsult SPRL /ID# 142860

    Charleroi, Hainaut, 6000

  • UZ Gent /ID# 142859

    Ghent, Oost-Vlaanderen, 9000

  • CHU de Liege /ID# 148401

    Liège, Liege, 4000

  • CHU Ambroise Pare /ID# 152953

    Mons, 7000

  • Cliniques Universitaires Saint Luc /ID# 142858

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Bulgaria5 sites

  • MHAT Trimontsium /ID# 142874

    Plovdiv, 4000

  • UMHAT Pulmed OOD /ID# 142877

    Plovdiv, 4000

  • MHAT Kaspela /ID# 142873

    Plovdiv, 4001

  • Diagnostic Consultative Center /ID# 142875

    Sofia, 1612

  • UMHAT Sv. Ivan Rilski /ID# 142876

    Sofia, 1612

Other trials in Bulgaria

Croatia5 sites

  • Klinicki bolnicki centar Rijeka /ID# 160232

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Split /ID# 152530

    Split, 21000

  • Clinical Hospital Dubrava /ID# 142900

    Zagreb, 10000

  • Medical Center Kuna-Peric /ID# 142901

    Zagreb, 10000

  • Poliklinika Bonifarm /ID# 142899

    Zagreb, 10000

Other trials in Croatia

Estonia5 sites

  • Paernu Hospital /ID# 142921

    Pärnu, 80010

  • Center of Clinical and Basic Research /ID# 142922

    Tallinn, Harju, 10128

  • East Tallinn Central Hospital /ID# 142923

    Tallinn, 10138

  • North Estonian Medical Centre /ID# 145454

    Tallinn, 13419

  • MediTrials /ID# 151870

    Tartu, Tartu, 50406

Other trials in Estonia

Israel5 sites

  • Rambam Health Care Campus /ID# 152050

    Haifa, 3109601

  • Bnai Zion Medical Center /ID# 151958

    Haifa, 3339419

  • The Lady Davis Carmel MC /ID# 142960

    Haifa, 3436212

  • Sheba Medical Center /ID# 145965

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Ctr /ID# 144709

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Latvia5 sites

  • LTD M+M Centers /ID# 142984

    Adazi, 2164

  • Daugavpils Regional Hospital /ID# 142982

    Daugavpils, 5417

  • D.Saulites-Kandevicas PP /ID# 142985

    Liepāja, 3401

  • Clinic ORTO /ID# 142983

    Riga, 1005

  • Riga East Clinical Univ Hosp /ID# 142981

    Riga, 1038

Other trials in Latvia

Malaysia5 sites

  • Hospital Selayang /ID# 156756

    Batu Caves, 68100

  • Hospital Raja Perempuan Zainab II /ID# 157862

    Kota Bharu, Kelantan, 15586

  • Hospital Umum Sarawak /ID# 142990

    Kuching, 93586

  • Hospital Putrajaya /ID# 142989

    Putrajaya, 62250

  • Hospital Tuanku Ja afar /ID# 142988

    Seremban, 70300

Other trials in Malaysia

Spain5 sites

  • Comple Hosp Univ de A Coruna /ID# 143051

    A Coruña, 15006

  • Hospital Universitario Reina S /ID# 153566

    Córdoba, 14004

  • H. Un. Marques de Valdecilla /ID# 143050

    Santander, Cantabria, 39008

  • Clinica Gaias /ID# 143052

    Santiago de Compostela, 15702

  • Complejo Hosp Santiago /ID# 153727

    Santiago de Compostela, 15706

Other trials in Spain

Italy4 sites

  • Azienda Ospedaliera Luigi Sacc /ID# 142966

    Milan, 20157

  • Istituto Clinico Humanitas /ID# 147528

    Rozzano, Milano, 20089

  • AOU Citta della Salute Scienza /ID# 150070

    Turin, Piedmont, 10126

  • A.O.U.I. di Verona Policlinico /ID# 142963

    Verona, 37134

Other trials in Italy

Kazakhstan4 sites

  • JSC Nat Scientific Med Res Ctr /ID# 142971

    Astana, 010009

  • Karaganda State Medical Univ /ID# 153433

    Karaganda, 100008

  • Semey State Medical University /ID# 152659

    Semey, 071403

  • Regional Clinical Hospital /ID# 147168

    Shymkent, 160000

Other trials in Kazakhstan

Bosnia and Herzegovina3 sites

  • University Clinical Centre of the Republic of Srpska /ID# 142862

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 142863

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 142865

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Greece3 sites

  • General Hospital of Athens Laiko /ID# 142934

    Athens, Attica, 115 27

  • University General Hospital Attikon /ID# 142933

    Athens, Attica, 12462

  • General Hospital of Athens Ippokratio /ID# 142935

    Athens, 11527

Other trials in Greece

New Zealand3 sites

  • Waikato Hospital /ID# 143002

    Hamilton, Waikato Region, 3204

  • Porter Rheumatology Ltd /ID# 143001

    Nelson, 7010

  • Timaru Medical Specialists Ltd /ID# 143000

    Timaru, 7910

Other trials in New Zealand

Turkey (Türkiye)3 sites

  • Istanbul Universitesi Cerrahpa /ID# 156088

    Cerrahpaşa, 34098

  • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 143063

    Istanbul, 34147

  • Izmir Katip Celebi Ataturk Training & Research Hospital /ID# 143062

    Izmir, 35360

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • The Royal Free Hospital /ID# 143074

    London, London, City of, NW3 2QG

  • Queen Alexandra Hospital /ID# 143077

    Portsmouth, PO6 3LY

  • Warrington + Halton Hosp NHS /ID# 143075

    Warrington, WA5 1LZ

Other trials in United Kingdom

Australia2 sites

  • Emeritus Research /ID# 142848

    Camberwell, Victoria, 3124

  • Royal Prince Alfred Hospital /ID# 144857

    Camperdown, New South Wales, 2050

Other trials in Australia

Denmark2 sites

  • Aarhus University Hospital /ID# 158838

    Aarhus N, Central Jutland, 8200

  • Regionhospital Silkeborg /ID# 142914

    Silkeborg, 8600

Other trials in Denmark

Hong Kong2 sites

  • Queen Mary Hospital /ID# 142938

    Hong Kong, 999077

  • Tuen Mun Hospital /ID# 142939

    Tuenmen, 999077

Other trials in Hong Kong

Lithuania2 sites

  • Hosp Lithuanian Univ Health Sc /ID# 142986

    Kaunas, Kaunas County, 50009

  • Vilnius University Hospital /ID# 142987

    Vilnius, LT-08661

Other trials in Lithuania

Puerto Rico2 sites

  • Ponce School of Medicine /ID# 151961

    Ponce, 00716

  • GCM Medical Group /ID# 143011

    San Juan, 00909

Other trials in Puerto Rico

Austria1 site

  • LKH-Univ. Klinikum Graz /ID# 142851

    Graz, 8036

Other trials in Austria

Belarus1 site

  • First City Clinical Hospital /ID# 158011

    Minsk, 220013

Other trials in Belarus

Ireland1 site

  • St Vincent's University Hosp /ID# 142957

    Dublin, D04 T6F4

Other trials in Ireland

About this study

Official title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

Read the detailed description

This study consists of a 48-week double-blind treatment period (Period 1) and a long-term extension period (Period 2).

Period 1 is a 48-week randomized, double-blind, parallel-group, placebo-controlled and active comparator-controlled period designed to compare the safety and efficacy of upadacitinib versus placebo, and versus adalimumab. Participants will be randomized in a 2:2:1 ratio to one of three treatment groups:

  • Placebo (up to Week 26)
  • Upadacitinib 15 mg once daily (QD)
  • Adalimumab 40 mg every other week (eow)

Participants randomized to placebo who do not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib treatment. At Week 26, all participants still receiving placebo will be switched to blinded upadacitinib treatment regardless of clinical response.

Participants randomized to adalimumab who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded upadacitinib. Participants still receiving adalimumab at Week 26 who do not achieve low disease activity (LDA) according to Clinical Disease Activity Index (CDAI; LDA is defined as CDAI ≤ 10) will be switched to blinded upadacitinib treatment to Week 48.

Participants randomized to upadacitinib who do not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline will be switched to blinded adalimumab; participants still receiving upadacitinib at Week 26 who do not achieve LDA (CDAI ≤ 10) will be switched to blinded adalimumab treatment to Week 48.

Participants who complete the Week 48 visit (end of Period 1) will enter the long-term extension phase of the study (Period 2), for up to 5 years. Participants will continue study treatment as assigned at the end of Period 1. Starting at the Week 48 and thereafter, at least 20% improvement in both TJC and SJC compared to Baseline is required to remain on study drug. Anyone who does not fulfill this criterion at 2 consecutive visits (starting at Week 48) will be discontinued.

Being tested
Placebo for Adalimumab, Adalimumab, Placebo for Upadacitinib, Upadacitinib
Keywords
Musculoskeletal disease, Arthritis, Joint disease, Anti-inflammatory agents, Antirheumatic agents
Medical subject headings
Arthritis, Rheumatoid, Musculoskeletal Diseases, Arthritis, Joint Diseases

What participants receive

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

  • Placebo for AdalimumabDrug

    Administered by subcutaneous injection once every other week

  • AdalimumabDrug

    Also called Humira

    Administered by subcutaneous injection once every other week

  • Placebo for UpadacitinibDrug

    Tablets taken orally once a day

  • UpadacitinibDrug

    Also called ABT-494

    Tablets taken orally once a day

Study groups in NCT02629159
Study groupRoleWhat they receive
Placebo followed by ABT-494Placebo comparatorParticipants were to receive placebo to upadacitinib orally once daily (QD) and placebo to adalimumab by subcutaneous injection once every two weeks (eow) for up to 26 weeks. Participants who did not achieve a ≥ 20% improvement in tender joint count (TJC) and swollen joint count (SJC) at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26, all remaining participants were to be switched to 15 mg upadacitinib QD until Week 48 (end of Period 1). Participants who complete Period 1 will continue to receive 15 mg upadacitinib orally QD for up to 5 years in Period 2.
Receives: Drug: Placebo for Adalimumab; Drug: Placebo for Upadacitinib; Drug: Upadacitinib
AdalimumabActive comparatorParticipants were to receive placebo to upadacitinib orally QD and 40 mg adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 15 mg upadacitinib orally QD. At Week 26 remaining participants who did not achieve low disease activity (defined as Clinical Disease Activity Index [CDAI] ≤ 10) were to be switched to 15 mg upadacitinib orally QD until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Receives: Drug: Adalimumab; Drug: Placebo for Upadacitinib; Drug: Upadacitinib
UpadacitinibExperimentalParticipants were to receive 15 mg upadacitinib orally QD and placebo to adalimumab by subcutaneous injection eow for up to 48 weeks in Period 1. Participants who did not achieve a ≥ 20% improvement in TJC and SJC at Weeks 14, 18, or 22 compared to Baseline were to be switched to 40 mg adalimumab eow. At Week 26 remaining participants who did not achieve low disease activity (defined as CDAI ≤ 10) were to be switched to 40 mg adalimumab eow until Week 48. Participants who complete Period 1 will continue to receive the same treatment assigned at the end of Period 1 (15 mg upadacitinib QD or 40 mg adalimumab eow) for up to 5 years in Period 2.
Receives: Drug: Placebo for Adalimumab; Drug: Adalimumab; 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

    The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) 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

  2. Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12

    The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 12.

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28 score less than 2.6 indicates clinical remission.

    Measured: Week 12

Secondary outcomes (12)

  1. Change From Baseline in DAS28 (CRP) at Week 12

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

    Measured: Baseline and Week 12

  2. Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26

    The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.

    Joint erosion severity was assessed in 16 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 280 (worst).

    JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

    The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression.

    Measured: Baseline and Week 26

  3. 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

  4. 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

  5. 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

  6. Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12

    The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity.

    Measured: Week 12

  7. Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12

    Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.

    CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.

    Measured: Week 12

  8. Change From Baseline in Duration of Morning Stiffness at Week 12

    Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 12

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

    The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.

    Measured: Baseline and Week 12

  10. Change From Baseline in Patient's Assessment of Pain at Week 12

    Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates "no pain" and a score of 100 indicates "worst possible pain." A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 12

  11. Percentage of Participants With No Radiographic Progression at Week 26

    No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).

    Joint erosion severity was assessed in 16 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 280 (worst).

    Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).

    Measured: Baseline and Week 26

  12. 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

Timeline

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

  1. First posted14 Dec 2015 (estimated)
  2. Study start1 Dec 2015
  3. Primary completion27 Oct 2017
  4. Study completion30 Sep 2027 (estimated)

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
1,629 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02629159
Sponsor's protocol ID
M14-465
Other IDs
2022-501017-31-00
Acronym
SELECT-COMPARE
Status last verified
Aug 2025
First submitted
10 Dec 2015
Last updated
5 Aug 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, analyses plans, 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

  • Fleischmann R, Pangan AL, Song IH, Mysler E, Bessette L, Peterfy C, Durez P, Ostor AJ, Li Y, Zhou Y, Othman AA, Genovese MC. Upadacitinib Versus Placebo or Adalimumab in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate: Results of a Phase III, Double-Blind, Randomized Controlled Trial. Arthritis Rheumatol. 2019 Nov;71(11):1788-1800. doi: 10.1002/art.41032. Epub 2019 Aug 28.

    PubMed 31287230

  • Fleischmann R, Swierkot J, Durez P, Bessette L, Blanco R, Van den Bosch F, Geem D, Luo L, Smith LD, Caballero D, Meerwein S, Peterfy C, Tanaka Y, Mysler E. Long-term safety and efficacy of upadacitinib compared with adalimumab in patients with rheumatoid arthritis: 7-year data from the SELECT-COMPARE study. RMD Open. 2026 Jun 24;12(2):e006657. doi: 10.1136/rmdopen-2025-006657.

    PubMed 42342288

  • 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

  • Winthrop KL, Klaff J, Penn SK, Liu Y, Garcia C, Mysler E, Wells AF, Bu X, Fish I, Chen M, Cunningham AL. Immunogenicity of adjuvanted recombinant zoster vaccine in patients with rheumatoid arthritis treated with upadacitinib: 60-week results from a randomised controlled trial substudy. RMD Open. 2025 Aug 12;11(3):e005521. doi: 10.1136/rmdopen-2025-005521.

    PubMed 40803820

  • Gossec L, Patel J, Kadakia A, Fang S, Peng Y, Strengholt S, Taylor PC, Ostor A. Association between rapid and sustained remission and clinician- and patient-reported outcomes in patients with rheumatoid arthritis: post hoc analysis of data from the SELECT-COMPARE study. Arthritis Res Ther. 2025 Jun 13;27(1):123. doi: 10.1186/s13075-025-03580-1.

    PubMed 40514717

  • Fleischmann R, Swierkot J, Penn SK, Durez P, Bessette L, Bu X, Khan N, Li Y, Peterfy CG, Tanaka Y, Mysler E. Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study. RMD Open. 2024 May 28;10(2):e004007. doi: 10.1136/rmdopen-2023-004007.

    PubMed 38806190

  • Fleischmann R, Blanco R, Van den Bosch F, Bessette L, Song Y, Penn SK, McDearmon-Blondell E, Khan N, Chan K, Mysler E. Long-term Efficacy and Safety Following Switch Between Upadacitinib and Adalimumab in Patients with Rheumatoid Arthritis: 5-Year Data from SELECT-COMPARE. Rheumatol Ther. 2024 Jun;11(3):599-615. doi: 10.1007/s40744-024-00658-1. Epub 2024 Mar 18.

    PubMed 38498140

  • 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

  • Fleischmann R, Curtis JR, Charles-Schoeman C, Mysler E, Yamaoka K, Richez C, Palac H, Dilley D, Liu J, Strengholt S, Burmester G. Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme. Ann Rheum Dis. 2023 Sep;82(9):1130-1141. doi: 10.1136/ard-2023-223916. Epub 2023 Jun 12.

    PubMed 37308218

  • Conaghan PG, Pavelka K, Hsieh SC, Bonnington TL, Kent TC, Marchbank K, Edwards CJ. Evaluating the efficacy of upadacitinib in patients with moderate rheumatoid arthritis: a post-hoc analysis of the SELECT phase 3 trials. Rheumatol Adv Pract. 2023 Feb 8;7(1):rkad017. doi: 10.1093/rap/rkad017. eCollection 2023.

    PubMed 36794283

  • 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

  • Kakehasi AM, Radominski SC, Baravalle MD, Palazuelos FCI, Garcia-Garcia C, Arruda MS, Curi M, Liu J, Qiao M, Velez-Sanchez P, Vargas JI. Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program. Clin Rheumatol. 2023 May;42(5):1249-1258. doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.

    PubMed 36715850

  • Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

    PubMed 36125701

  • Mysler E, Tanaka Y, Kavanaugh A, Aletaha D, Taylor PC, Song IH, Shaw T, Song Y, DeMasi R, Ali M, Fleischmann R. Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE. Rheumatology (Oxford). 2023 May 2;62(5):1804-1813. doi: 10.1093/rheumatology/keac477.

    PubMed 36018230

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab and Upadacitinib in people with Rheumatoid Arthritis, run by AbbVie at 370 sites in 44 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 7 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 370 sites in United States, Russia, Poland, Argentina, Chile and 39 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 7 Oct 2019). 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). The study lists 2 primary outcomes in all. 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 NCT02629159, which also lists 22 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 5 Aug 2025.

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