AzTrials
AzTrials

Rheumatoid Arthritis (RA)Phase 3NCT03086343

A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs

A Phase 3 study testing Abatacept and Upadacitinib in people with Rheumatoid Arthritis (RA), run by AbbVie at 161 sites in 30 countries.

Completed

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

Official record
Search all trials

Trial summary

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
Abatacept and Upadacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
657 participants
Where
161 sitesin 30 countries
Study dates
9 May 2017to 6 Jun 2023
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

Main Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis (RA) for ≥ 3 months who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA
  • Participants have been treated for ≥ 3 months prior to the screening visit with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration and have never received abatacept prior to the first dose of study drug
  • Participants have been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide
  • Meets the following criteria: ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits and high-sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening

Main Exclusion Criteria:

  • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib and filgotinib)
  • Prior exposure to abatacept
  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted
  • Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 mL/minute/1.73 meter (m)^2; total white blood cell count < 2,500/ μL; absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte count < 800/μL; and hemoglobin < 10 g/dL

Trial locations and contacts

161 sites in 30 countries.

161 sites in 30 countries

United States44 sites

  • The Center for Rheumatology /ID# 162979

    Albany, New York, 12206

  • Ochsner Clinic Foundation /ID# 154585

    Baton Rouge, Louisiana, 70836-6455

  • East Penn Rheumatology Assoc /ID# 159193

    Bethlehem, Pennsylvania, 18015

  • PMG Research of Christie Clini /ID# 154569

    Champaign, Illinois, 61820

  • Clinical Res of West FL, Inc. /ID# 154576

    Clearwater, Florida, 33765

  • Adriana Pop-Moody MD Clinic PA /ID# 154607

    Corpus Christi, Texas, 78404

  • Jefrey D. Lieberman, MD, P.C. /ID# 157178

    Decatur, Georgia, 30033

  • Denver Arthritis Clinic /ID# 159195

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 154572

    Duncansville, Pennsylvania, 16635

  • Arthritis and Rheum Clin N. CO /ID# 155673

    Fort Collins, Colorado, 80528

  • Saint Jude Heritage /ID# 158833

    Fullerton, California, 92835

  • West Michigan Rheumatology /ID# 154551

    Grand Rapids, Michigan, 49546

  • Physicians East, PA /ID# 154565

    Greenville, North Carolina, 27834

  • CHI St. Vincent Medical Group /ID# 154561

    Hot Springs, Arkansas, 71913-6999

  • West Tennessee Research Inst /ID# 158721

    Jackson, Tennessee, 38305

  • Kotha and Kotha /ID# 154573

    La Mesa, California, 91942

  • NYU Langone Rheum Assoc /ID# 155236

    Lake Success, New York, 11554

  • Scientia Medical Research /ID# 159189

    Lakewood, Colorado, 80228

  • Advanced Rheumatology, PC /ID# 154589

    Lansing, Michigan, 48910

  • Arthritis and Osteo Assoc /ID# 154560

    Las Cruces, New Mexico, 88011

  • Bluegrass Community Research /ID# 154604

    Lexington, Kentucky, 40515

  • P&I Clinical Research /ID# 159191

    Lufkin, Texas, 75904-3132

  • Advanced Clinical Research /ID# 154603

    Meridian, Idaho, 83642

  • NYU Langone Medical Center /ID# 158829

    New York, New York, 10016-6402

  • Advanced Clin Res of Orlando /ID# 154580

    Ocoee, Florida, 34761-4547

  • Four Rivers Clinical Research /ID# 154606

    Paducah, Kentucky, 42003

  • Gulf Region Clinical Res Inst /ID# 154597

    Pensacola, Florida, 32514

  • SunValley Arthritis Center, Lt /ID# 154558

    Peoria, Arizona, 85381

  • University of Pittsburgh MC /ID# 157434

    Pittsburgh, Pennsylvania, 15260

  • Oregon Health and Science University /ID# 163822

    Portland, Oregon, 97239

  • PMG Research of Salisbury /ID# 154605

    Salisbury, North Carolina, 28144

  • Care Access Research /ID# 158098

    Salt Lake City, Utah, 84124-1377

  • Clinvest Research LLC /ID# 154554

    Springfield, Missouri, 65810-2607

  • Overlook Medical Center /ID# 154794

    Summit, New Jersey, 07901-3561

  • AZ Arthritis & Rheum Research /ID# 156539

    Sun City, Arizona, 85351

  • W. Broward Rheum Assoc Inc. /ID# 158835

    Tamarac, Florida, 33321

  • DM Clinical Research /ID# 158722

    Tomball, Texas, 77375

  • Atlantic Coast Research /ID# 155234

    Toms River, New Jersey, 08755

  • Ocean Rheumatology, PA /ID# 162980

    Toms River, New Jersey, 08755

  • AZ Arth & Rheum Res /ID# 167161

    Tucson, Arizona, 85704

  • Lovelace Scientific Resources /ID# 154600

    Venice, Florida, 34292

  • The Center for Rheumatology & Bone Research /ID# 158723

    Wheaton, Maryland, 20902

  • PMG Research of Wilmington LLC /ID# 154584

    Wilmington, North Carolina, 28401

  • Wake Forest Baptist Medical Center /ID# 154586

    Winston-Salem, North Carolina, 27157-0001

Other trials in United States

Argentina9 sites

  • Ctr Privado Med Familiar /ID# 158814

    Buenos Aires, 1417

  • Atencion Integral en Reuma /ID# 155696

    Buenos Aires, 1426AAL

  • Hospital General de Agudos /ID# 167117

    Buenos Aires, C1221ADC

  • Inst. de Rehab. Psicofisica /ID# 167768

    CABA, 1428

  • Aprillus Asistencia e Investig /ID# 159173

    Capital Federal, Buenos Aires, 1046

  • Inst. Rheumatologic Strusberg /ID# 159021

    Córdoba, 5000

  • Instituto Medico DAMIC /ID# 167770

    Córdoba, X5003DCE

  • DIM Clinica Privada /ID# 167769

    Ramos Mejía, 1704

  • Instituto CAICI SRL /ID# 159022

    Rosario, Santa FE, S2000PBJ

Other trials in Argentina

Brazil8 sites

  • Santa Casa de Belo Horizonte /ID# 154631

    Belo Horizonte, Minas Gerais, 30150-221

  • Ceti - Centro de Estudos Em Terapias Inovadoras Ltda /Id# 154634

    Curitiba, Paraná, 80030-110

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 154564

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital de Clinicas de Porto Alegre /ID# 161211

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 159176

    Porto Alegre, Rio Grande do Sul, 90480-000

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos /ID# 154632

    Santo André, São Paulo, 09190-510

  • CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda /ID# 159587

    São Paulo, São Paulo, 04266-010

  • CEDOES-Centro de Diagnóstico e Pesquisa da Osteoporose do Espírito Santo LTDA /ID# 155228

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

Poland8 sites

  • Gabinet Internistyczno Reum. /ID# 157433

    Bialystok, Podlaskie Voivodeship, 15-099

  • ClinicMed Daniluk, Nowak Sp.j. /ID# 202998

    Bialystok, Podlaskie Voivodeship, 15-879

  • Malopolskie Centrum Kliniczne /ID# 157180

    Cracow, Lesser Poland Voivodeship, 30-149

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni /ID# 202472

    Gdynia, Pomeranian Voivodeship, 81-537

  • Centrum Med Amed Oddzial Lodzi /ID# 154458

    Lodz, 91-363

  • Salve Medica Sp. z o.o. S.K. /ID# 202473

    Lodz, Łódź Voivodeship, 91-211

  • Medyczne Centrum Hetmanska /ID# 155746

    Poznan, Greater Poland Voivodeship, 60-218

  • Centrum Medyczne AMED Warszawa Targowek /ID# 159589

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Italy6 sites

  • A.O. Univ. Ospedali Riuniti /ID# 161707

    Ancona, The Marches, 60126

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele /ID# 161172

    Catania, 95123

  • ASST G. Pini /ID# 162223

    Milan, 20122

  • Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 162252

    Rome, Roma, 00168

  • Istituto Clinico Humanitas /ID# 154999

    Rozzano, Milano, 20089

  • AOU Citta della Salute Scienza /ID# 154577

    Turin, Piedmont, 10126

Other trials in Italy

Portugal6 sites

  • Hospital Garcia de Orta, E.P.E /ID# 164056

    Almada, Setúbal District, 2805-267

  • Instituto Portugues De Reumatologia /ID# 155698

    Lisbon, Lisbon District, 1050-034

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 200035

    Lisbon, Lisbon District, 1349-019

  • Centro Hospitalar Lisboa Norte, EPE /ID# 200037

    Lisbon, 1649-035

  • Unidade Local De Saude Do Alto Minho /ID# 200036

    Viana do Castelo, 4901-858

  • Centro Hosp de Tondela-Viseu /ID# 155699

    Viseu, 3504-509

Other trials in Portugal

Spain6 sites

  • Hospital Universitario Reina S /ID# 155701

    Córdoba, 14004

  • Hospital General Univ de Elche /ID# 158825

    Elche, 03202

  • Hospital Universitario La Paz /ID# 163636

    Madrid, 28046

  • Corp Sanitaria Parc Tauli /ID# 163634

    Sabadell, Barcelona, 08208

  • Complejo Hospitalario /ID# 155700

    Santiago de Compostela, 15706

  • Hospital Infanta Luisa /ID# 154641

    Seville, 41010

Other trials in Spain

Hungary5 sites

  • Budai Irgalmasrendi Korhaz /ID# 154457

    Budapest, 1023

  • Obudai Egeszsegugyi Centrum Kft. /ID# 156159

    Budapest, 1036

  • Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 159183

    Debrecen, 4031

  • Markhot Ferenc Oktatokorhaz es Rendelointezet /ID# 159689

    Eger, 3300

  • MAV Korhaz ess Rendelointezet /ID# 154455

    Szolnok, 5000

Other trials in Hungary

Mexico5 sites

  • Centro Integral en Reumatología S.A de C.V /ID# 204493

    Guadalajara, Jalisco, 44160

  • Morales Vargas Centro de Investigacion S.C. /ID# 200800

    León, Guanajuato, 37000

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 154579

    Mexico City, Mexico City, 11850

  • RM Pharma Specialists S.A de C.V /ID# 159588

    Mexico City, 03100

  • Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiova /ID# 160126

    Mexico City, 11650

Other trials in Mexico

Russia5 sites

  • Alliance Biomedical Ural Group /ID# 154609

    Izhevsk, Udmurtiya Republic, 426061

  • Family Outpatient clinic#4 LLC /ID# 203524

    Korolev, Moscow, 141060

  • State Budget Healthcare Instit /ID# 154593

    Moscow, 121374

  • LLC Medical Center /ID# 203523

    Novosibirsk, Novosibirsk Oblast, 630099

  • Nort-Western State Medical Uni /ID# 154610

    Saint Petersburg, 191015

Other trials in Russia

United Kingdom5 sites

  • Ninewells Hospital /ID# 156050

    Dundee, DD1 9SY

  • Whipps Cross Univ Hospital /ID# 205985

    London, London, City of, E11 1NR

  • Altnagelvin Area Hospital /ID# 156540

    Londonderry, BT47 6SB

  • Lancashire Care NHS Foundation /ID# 156042

    Preston

  • Royal Cornwall Hospital /ID# 157785

    Truro, TR1 3LJ

Other trials in United Kingdom

Bulgaria4 sites

  • MHAT Trimontsium /ID# 155226

    Plovdiv, 4000

  • Diag Consult Ctr 17 Sofia EOOD /ID# 169298

    Sofia, 1505

  • UMHAT Sv. Ivan Rilski /ID# 155000

    Sofia, 1612

  • Medical Centre Synexus Sofia /ID# 201807

    Sofia, 1784

Other trials in Bulgaria

Canada4 sites

  • The Waterside Clinic /ID# 159178

    Barrie, Ontario, L4M 6L2

  • Adachi Medicine Prof. Corp /ID# 158024

    Hamilton, Ontario, L8N 1Y2

  • Institut de Rhum. de Montreal /ID# 155001

    Montreal, Quebec, H2L 1S6

  • Groupe de Recherche en Maladies Osseuses /ID# 154601

    Sainte-Foy, Quebec, G1V 3M7

Other trials in Canada

Germany4 sites

  • Praxis fuer Rheumatologie /ID# 156156

    Berlin, 12163

  • Uniklinik Koln /ID# 156047

    Cologne, North Rhine-Westphalia, 50937

  • Rheumaforschungszentrum II /ID# 157177

    Hamburg, 20095

  • Welcker, Planegg, DE /ID# 160185

    Planegg, 82152

Other trials in Germany

Israel4 sites

  • Barzilai Medical Center /ID# 161685

    Ashkelon, 78278

  • The Lady Davis Carmel MC /ID# 161686

    Haifa, 3436212

  • Meir Medical Center /ID# 162774

    Kfar Saba, 44281

  • Sheba Medical Center /ID# 163154

    Ramat Gan, 5262100

Other trials in Israel

Netherlands4 sites

  • Reade /ID# 161002

    Amsterdam, 1056 AB

  • Spaarne Gasthuis /ID# 161003

    Haarlem, 2035 RC

  • Medisch Centrum Leeuwarden /ID# 156043

    Leeuwarden, 8934 AD

  • Antonius Ziekenhuis /ID# 155737

    Sneek, Provincie Friesland, 8601 ZK

Other trials in Netherlands

Sweden4 sites

  • Sahlgrenska University Hosp /ID# 162775

    Gothenburg, 413 45

  • Skanes Universitetssjukhus /ID# 165133

    Malmö, Skåne County, 214 28

  • Akademiskt specialistcentrum Centrum for reumatologi /ID# 156046

    Stockholm, Stockholm County, 113 65

  • Vastmanlands Sjukhus /ID# 159186

    Västerås, 72189

Other trials in Sweden

Switzerland4 sites

  • University Hospital of Basel /ID# 160860

    Basel, 4031

  • HFR Fribourg - Hopital Canton /ID# 160970

    Fribourg, 1708

  • Hopitaux Universitaires de Geneve /ID# 159083

    Geneva, Canton of Geneva, 1205

  • Kantonsspital St. Gallen /ID# 155232

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Turkey (Türkiye)4 sites

  • Hacettepe University Medical Faculty /ID# 167995

    Ankara, 06100

  • Ankara Univ Medical Faculty /ID# 162691

    Ankara, 6100

  • Akdeniz University Faculty /ID# 163153

    Antalya, 06100

  • Istanbul Fizik Tedavi Rehabilitasyon Egitim ve Arastırma Hastanesi /ID# 169479

    Istanbul, 34147

Other trials in Turkey (Türkiye)

Australia3 sites

  • Western Health Footscray Hospi /ID# 157968

    Footscray, Victoria, 3011

  • Rheumatology Research Unit /ID# 159174

    Maroochydore, Queensland, 4558

  • The Queen Elizabeth Hospital /ID# 159175

    Woodville, South Australia, 5011

Other trials in Australia

Slovakia3 sites

  • Novamed,spol.s.r.o. /ID# 157928

    Banská Bystrica, 97405

  • Univerzitna Nemocnica Bratislava /ID# 161143

    Bratislava, 82606

  • Narodny ustav reumatickych chorob Piestany /ID# 156864

    Pieštany, 921 12

Other trials in Slovakia

South Korea3 sites

  • SMG-SNU Boramae Medical Center /ID# 155788

    Seoul, Seoul Teugbyeolsi, 07061

  • The Catholic University of Korea, Yeouido St. Mary's Hospital /ID# 155231

    Seoul, Seoul Teugbyeolsi, 07345

  • Asan Medical Center /ID# 154639

    Seoul, 05505

Other trials in South Korea

Czechia2 sites

  • Revmatologicky ustav Praha /ID# 154612

    Prague, Praha 2, 128 00

  • Medical Plus, s.r.o. /ID# 155230

    Uherské Hradište, 686 01

Other trials in Czechia

Latvia2 sites

  • D.Saulites-Kandevicas PP /ID# 154578

    Liepāja, 3401

  • Riga East Clinical Univ Hosp /ID# 155024

    Riga, 1038

Other trials in Latvia

New Zealand2 sites

  • Timaru Medical Specialists Ltd /ID# 159184

    Timaru, 7910

  • Wellington Hospital (Capital and Coast District Health Board) /ID# 154591

    Wellington, 6021

Other trials in New Zealand

Puerto Rico2 sites

  • Dr. Ramon L. Ortega-Colon, MD /ID# 158097

    Carolina, 00983

  • GCM Medical Group /ID# 156158

    San Juan, 00909

Other trials in Puerto Rico

Romania2 sites

  • Spitalul Clinic Dr. I. Cantacuzino /ID# 155893

    Bucharest, Bucharest, 020475

  • Spitalul Clinic Sf. Maria /ID# 167245

    Bucharest, 011172

Other trials in Romania

Belgium1 site

  • CHU UCL Namur /ID# 157628

    Namur, 5000

Other trials in Belgium

Greece1 site

  • University General Hospital of Heraklion "PA.G.N.I" /ID# 163916

    Heraklion, 71110

Other trials in Greece

Ireland1 site

  • Our Lady's Hospital /ID# 161149

    Manorhamilton

Other trials in Ireland

About this study

Official title: A Phase 3, Randomized, Active-Controlled, Double-Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

The study objective of Period 1 was to compare the safety and efficacy of upadacitinib 15 mg once daily (QD) to abatacept on a background of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in biologic disease-modifying antirheumatic drug (bDMARD)-inadequate response or bDMARD-intolerant participants with moderately to severely active RA. The study objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in participants with RA who had completed Period 1.

Read the detailed description

This is a Phase 3 multicenter study with 2 periods. Period 1 was a 24-week, randomized, double-blind, parallel-group, active-controlled period designed to compare the safety and efficacy of upadacitinib 15 mg and abatacept for the treatment of signs and symptoms of participants with moderately to severely active RA who had an inadequate response to or intolerance to bDMARD therapy and were currently on a stable dose of csDMARD(s) and had never received abatacept. Period 2 is an open-label, long-term extension study to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg once a day (QD) in participants with RA who had completed Period 1.

Being tested
Abatacept, Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion), Upadacitinib, Placebo for 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.

  • AbataceptDrug

    IV infusion

  • Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion)Drug

    IV infusion

  • UpadacitinibDrug

    Also called ABT-494

    15 mg extended release tablet

  • Placebo for upadacitinibDrug

    Film-coated tablet

Study groups in NCT03086343
Study groupRoleWhat they receive
Primary Cohort: Abatacept/Upadacitinib 15 mg QDActive comparatorPeriod 1: 500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
Receives: Drug: Abatacept; Drug: Upadacitinib; Drug: Placebo for upadacitinib
Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QDExperimentalPeriod 1: One 15 mg upadacitinib oral tablet QD for 24 weeks. Period 2: open label upadacitinib 15 mg QD for 192 weeks.
Receives: Drug: Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion); Drug: Upadacitinib
30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QDExperimentalPeriod 1: One upadacitinib 30 mg oral tablet QD for 24 weeks. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
Receives: Drug: Placebo for abatacept (0.9% Sodium Chloride Injection or Solution for Infusion); Drug: Upadacitinib
30 mg Cohort: Abatacept/Upadacitinib 30 mg QDActive comparatorPeriod 1: 500 mg (for body weight <60 kg); 750 mg (for body weight 60-100 kg); and 1000 mg (for body weight >100 kg) IV infusion at Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 and Week 20. Period 2: open label upadacitinib 30 mg (reduced to 15 mg per Amendment 5) QD for 192 weeks.
Receives: Drug: Abatacept; Drug: Upadacitinib; Drug: Placebo for upadacitinib

What is being measured

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

  1. Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority)

    The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.

    Measured: Baseline and Week 12

Secondary outcomes (2)

  1. Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)

    The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (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 indicates improvement in disease activity.

    Measured: Baseline and Week 12

  2. Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Superiority)

    The Disease Activity Score (DAS) 28 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 high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A DAS 28 score less than 2.6 indicates clinical remission.

    Measured: At 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 posted22 Mar 2017
  2. Study start9 May 2017
  3. Primary completion13 Jun 2019
  4. Study completion6 Jun 2023

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
657 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086343
Sponsor's protocol ID
M15-925
Other IDs
2016-000933-37, 2016
Status last verified
Jul 2024
First submitted
20 Mar 2017
Last updated
18 Jul 2024
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

  • Rubbert-Roth A, Enejosa J, Pangan AL, Haraoui B, Rischmueller M, Khan N, Zhang Y, Martin N, Xavier RM. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020 Oct 15;383(16):1511-1521. doi: 10.1056/NEJMoa2008250.

    PubMed 33053283

  • 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

  • Rubbert-Roth A, Kato K, Haraoui B, Rischmueller M, Liu Y, Khan N, Camp HS, Xavier RM. Safety and Efficacy of Upadacitinib in Patients with Rheumatoid Arthritis Refractory to Biologic DMARDs: Results Through Week 216 from the SELECT-CHOICE Study. Rheumatol Ther. 2024 Oct;11(5):1197-1215. doi: 10.1007/s40744-024-00694-x. Epub 2024 Jul 20.

    PubMed 39031276

  • 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

  • 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, Tundia N, Martin N, Suboticki JL, Patel J, Goldschmidt D, Song Y, Wright GC. Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial. Arthritis Res Ther. 2022 Jun 24;24(1):155. doi: 10.1186/s13075-022-02813-x.

    PubMed 35751108

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abatacept and Upadacitinib in people with Rheumatoid Arthritis (RA), run by AbbVie at 161 sites in 30 countries.

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

Who may be eligible to take part?

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 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Argentina, Brazil, Poland, Italy and 25 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. 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 4 Jun 2020). 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?

Change From Baseline in Disease Activity Score (DAS) 28 C-Reactive Protein (CRP) at Week 12 (Non-inferiority) (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 NCT03086343, which also lists 9 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 18 Jul 2024.

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