AzTrials
AzTrials

Rheumatoid ArthritisPhase 3SELECT- SWITCHNCT05814627

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

A Phase 3 study testing Upadacitinib and Adalimumab in people with Rheumatoid Arthritis, run by AbbVie at 218 sites in 25 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

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are… 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?
Upadacitinib and Adalimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
487 participants
Where
218 sitesin 25 countries
Study dates
15 Jun 2023to 15 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
  • Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
  • On oral or parenteral methotrexate (MTX) therapy >= 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.
  • For a Chinese, Japanese, Korean, or Taiwanese participant, a stable dose of MTX >= 7.5 mg/week is acceptable.
  • Additional local requirements for MTX may apply.
  • Meets both of the following disease activity criteria:
  • >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline;
  • High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L) at screening.

Who cannot join

  • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
  • Prior exposure to any janus kinase (JAK) inhibitor.
  • Prior exposure to adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab.
  • Prior exposure to an approved or investigational non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying antirheumatic drug (tsDMARD).

Trial locations and contacts

218 sites in 25 countries.

218 sites in 25 countries

United States85 sites

  • Arthritis and Rheumatology Research Institute, PLLC /ID# 254045

    Allen, Texas, 75013-6147

  • University of Colorado Hospital /ID# 254617

    Aurora, Colorado, 80045

  • Tekton Research, L.L.C /ID# 254004

    Austin, Texas, 78745

  • Arthritis and Rheumatic Disease Specialties /ID# 260583

    Aventura, Florida, 33180

  • Ochsner Health Center - The Grove /ID# 254059

    Baton Rouge, Louisiana, 70836

  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733

    Boca Raton, Florida, 33486

  • Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029

    Boston, Massachusetts, 02149-4903

  • Bay Area Arthritis and Osteo /ID# 254046

    Brandon, Florida, 33511

  • NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621

    Brooklyn, New York, 11201

  • Trinity Universal Research Associates - Carrollton /ID# 254648

    Carrollton, Texas, 75007

  • Joint And Muscle Research Institute /ID# 275128

    Charlotte, North Carolina, 28204

  • Next Innovative Clinical Research - Chicago /ID# 273453

    Chicago, Illinois, 60616

  • Believe Clinical Trial /ID# 262355

    Coral Springs, Florida, 33065

  • Adriana Pop-Moody MD Clinic PA /ID# 255030

    Corpus Christi, Texas, 78404

  • International Medical Research /ID# 254651

    Daytona Beach, Florida, 32117

  • Omega Research Debary, LLC /ID# 253735

    DeBary, Florida, 32713-2260

  • Denver Arthritis Clinic /ID# 254058

    Denver, Colorado, 80230

  • St. Paul Rheumatology, PA /ID# 255037

    Eagan, Minnesota, 55121

  • Qualmedica Research - Evansville /ID# 254005

    Evansville, Indiana, 47715-2813

  • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431

    Flagstaff, Arizona, 86001-6299

  • Tekton Research - Fort Collins - East Harmony Road /ID# 255036

    Fort Collins, Colorado, 80528

  • JPS Rheumatology Clinic /ID# 254050

    Fort Worth, Texas, 76104-4917

  • Aurora Rheumatology and Immunotherapy Center /ID# 254049

    Franklin, Wisconsin, 53132

  • Providence - St. Jude Medical Center /ID# 252690

    Fullerton, California, 92835

  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018

    Glendale, Arizona, 85306-9802

  • Rheumatic Disease Center, LLP /ID# 254015

    Glendale, Wisconsin, 53217

  • AA Medical Research Center - Grand Blanc /ID# 254007

    Grand Blanc, Michigan, 48439

  • Arthritis Associates /ID# 253992

    Hattiesburg, Mississippi, 39402

  • Neoclinical Research /ID# 254622

    Hialeah, Florida, 33016-1897

  • Gnp Research - Hollywood /ID# 273563

    Hollywood, Florida, 33024

  • Western KY Rheumatology /ID# 255026

    Hopkinsville, Kentucky, 42240

  • Biopharma Informatic - Houston - Business Center Drive /ID# 254051

    Houston, Texas, 77043

  • Accurate Clinical Research - Houston /ID# 254647

    Houston, Texas, 77089-6142

  • Research Physicians Network, LLC /ID# 254053

    Houston, Texas, 77089

  • Newport Huntington Medical Group /ID# 252687

    Huntington Beach, California, 92648-5994

  • West Tennessee Research Institute /ID# 254620

    Jackson, Tennessee, 38305

  • Arthritis and Rheumatism Associates /ID# 254013

    Jonesboro, Arkansas, 72401-6251

  • Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 253738

    Kalispell, Montana, 59901

  • Kansas City Physician Partners /ID# 255035

    Kansas City, Missouri, 64151

  • R & H Clinical Research - 777 Katy /ID# 255024

    Katy, Texas, 77450-2244

  • Purushotham & Akther Kotha MD, Inc /ID# 252704

    La Mesa, California, 91942

  • Arthritis and Osteoporosis Associates of New Mexico /ID# 252684

    Las Cruces, New Mexico, 88011

  • Dartmouth-Hitchcock Medical Center /ID# 253798

    Lebanon, New Hampshire, 03756

  • Bluegrass Community Research /ID# 254653

    Lexington, Kentucky, 40504

  • Deerbrook Medical Associates /ID# 254008

    Libertyville, Illinois, 60048

  • Physician Research Collaboration, LLC /ID# 254012

    Lincoln, Nebraska, 68516

  • Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692

    Los Alamitos, California, 90720-5402

  • West Texas Clinical Research /ID# 253736

    Lubbock, Texas, 79424

  • Life Clinical Trials /ID# 256061

    Margate, Florida, 33063

  • Atlanta Research Center For Rheumatology - Marietta /ID# 254623

    Marietta, Georgia, 30060

  • Lakes Research, LLC /ID# 255023

    Miami, Florida, 33014

  • Paramount Medical Research and Consulting /ID# 254048

    Middleburg Heights, Ohio, 44130

  • Trinity Health Med Arts Clinic /ID# 254010

    Minot, North Dakota, 58701

  • The Arthritis & Diabetes Clinic, Inc. /ID# 254014

    Monroe, Louisiana, 71203

  • Advanced Rheumatology, PC /ID# 256059

    Okemos, Michigan, 48910

  • Rheumatology Associates of Oklahoma /ID# 253994

    Oklahoma City, Oklahoma, 73116-7226

  • HMD Research LLC /ID# 253732

    Orlando, Florida, 32819

  • Millennium Research /ID# 253744

    Ormond Beach, Florida, 32174

  • Vitalia Research /ID# 274213

    Palm Beach Gardens, Florida, 33410

  • Sun Valley Arthritis Center Ltd. /ID# 254654

    Peoria, Arizona, 85381

  • Clinical Research of Philadelphia, LLC /ID# 255025

    Philadelphia, Pennsylvania, 19114

  • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432

    Phoenix, Arizona, 85032

  • Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021

    Phoenix, Arizona, 85032

  • Trinity Universal Research Associates, Inc /ID# 253995

    Plano, Texas, 75024-5283

  • Rheumatology Associates PA - Portland /ID# 255014

    Portland, Maine, 04102-2643

  • OrthoIllinois /ID# 254057

    Rockford, Illinois, 61114-4937

  • Sun Research Institute /ID# 255019

    San Antonio, Texas, 78215

  • Rheumatology Center of San Diego /ID# 255038

    San Diego, California, 92128-2549

  • Greater Chicago Specialty Physicians /ID# 254000

    Schaumburg, Illinois, 60195-3106

  • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999

    Skokie, Illinois, 60076

  • Clinvest Research LLC /ID# 254054

    Springfield, Missouri, 65807

  • BayCare Medical Group /ID# 253799

    St. Petersburg, Florida, 33705

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 254649

    Tampa, Florida, 33606

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 255264

    Tampa, Florida, 33606

  • University of South Florida- Neuroscience Institute /ID# 253745

    Tampa, Florida, 33613

  • Baycare Medical Group - Tampa /ID# 255268

    Tampa, Florida, 33614

  • Advanced Rheumatology of Houston /ID# 254003

    The Woodlands, Texas, 77382

  • Millennium Clinical Trials /ID# 252689

    Thousand Oaks, California, 91360-3951

  • DM Clinical Research - Tomball /ID# 254001

    Tomball, Texas, 77375

  • Rheumatology Clinic of Houston /ID# 254002

    Tomball, Texas, 77377

  • The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691

    Torrance, California, 90502

  • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017

    Tucson, Arizona, 85704

  • Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266

    Voorhees Township, New Jersey, 08043

  • Willow Rheumatology and Wellness, PLLC /ID# 254712

    Willowbrook, Illinois, 60527

  • Comprehensive Rheumatology Center /ID# 252688

    Woodland Hills, California, 91364

Other trials in United States

Japan21 sites

  • Katayama Orthopedic Rheumatology Clinic /ID# 252746

    Asahikawa-shi, Hokkaido, 078-8243

  • St. Lukes International Hospital /ID# 253131

    Chuo-ku, Tokyo, 104-8560

  • Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774

    Fukui-shi, Fukui, 910-0068

  • Hamanomachi Hospital /ID# 253168

    Fukuoka, Fukuoka, 810-8539

  • Shono Rheumatism Clinic /ID# 252591

    Fukuoka, Fukuoka, 814-0002

  • Rinku Hashimoto Rheumatology Orthopaedics /ID# 270396

    Izumisano, Osaka, 598-0048

  • Kashiwa Kousei General Hospital /ID# 270033

    Kashiwa-shi, Chiba, 277-8551

  • Matsubara Mayflower Hospital /ID# 252834

    Kato-shi, Hyōgo, 673-1462

  • Bay Side Misato Medical Center /ID# 252661

    Kochi, Kochi, 781-0112

  • Kumamoto Orthopaedic Hospital /ID# 253167

    Kumamoto, Kumamoto, 8620975

  • Medical Corporation Keiai Kai Clinic /ID# 252750

    Miyazaki, Miyazaki, 880-0053

  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836

    Nagoya, Aichi-ken, 455-8530

  • Daido Clinic - Nagoya /ID# 253058

    Nagoya, Aichi-ken, 457-8511

  • Maeshima Rheumatology Clinic /ID# 270448

    Ōita, 870-0823

  • Sanuki Municipal Hospital /ID# 252747

    Sanuki-shi, Kagawa-ken, 769-2393

  • Sagawa Akira Rheumatology Clin /ID# 252773

    Sapporo, Hokkaido, 060-0001

  • Hokkaido Medical Center For Rheumatic Diseases /ID# 270019

    Sapporo, Hokkaido, 063-0811

  • Sasebo Chuo Hospital /ID# 252662

    Sasebo-shi, Nagasaki, 857-1195

  • Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057

    Shimonoseki-shi, Yamaguchi, 752-0976

  • Keio University Hospital /ID# 253205

    Shinjuku-ku, Tokyo, 160-8582

  • Toyama Prefectural Central Hospital /ID# 270871

    Toyama, 930-0975

Other trials in Japan

China8 sites

  • Peking University First Hospital /ID# 252392

    Beijing, Beijing Municipality, 100034

  • Peking University Third Hospital /ID# 252393

    Beijing, Beijing Municipality, 100191

  • The first affiliated hospital of bengbu medical college /ID# 252612

    Bengbu, Anhui, 233004

  • West China Hospital, Sichuan University /ID# 252364

    Chengdu, Sichuan, 610041

  • The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252394

    Guangzhou, Guangdong, 510630

  • Nanjing Drum Tower Hospital /ID# 252613

    Nanjing, Jiangsu, 210008

  • Jiangxi Pingxiang Peoples Hospital /ID# 252381

    Pingxiang, Jiangxi, 337055

  • Zhuzhou Central Hospital /ID# 252390

    Zhuzhou, Hunan, 412007

Other trials in China

Bulgaria7 sites

  • Umbal Kaspela /ID# 252343

    Plovdiv, 4001

  • Medical center Unimed /ID# 252344

    Plovdiv, 4023

  • MHAT Plovdiv /ID# 252342

    Plovdiv, 4027

  • Diagnostic consultative center 17 Sofia /ID# 252341

    Sofia, 1505

  • Military Medical Academy Multiprofile Hospital /ID# 252355

    Sofia, 1606

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252354

    Sofiya, Sofia, 1463

  • Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252555

    Sofiya, Sofia, 1463

Other trials in Bulgaria

South Africa7 sites

  • Winelands Medical Research - Somerset West /ID# 252745

    Cape Town, Western Cape, 7130

  • Arthritis Clinical Research Trials /ID# 252370

    Cape Town, Western Cape, 7405

  • University of Pretoria /ID# 252368

    Pretoria, Gauteng, 0001

  • Dr Elsa van Duuren /ID# 252387

    Pretoria, Gauteng, 0002

  • Emmed Research cc /ID# 254317

    Pretoria, Gauteng, 0002

  • Winelands Medical Research Centre /ID# 252369

    Stellenbosch, Western Cape, 7600

  • Dr Asokan Naidoo /ID# 252894

    Umhlanga, KwaZulu-Natal, 4319

Other trials in South Africa

Brazil6 sites

  • CETI - Centro de Estudos em Terapias Inovadoras /ID# 254201

    Curitiba, Paraná, 80030-110

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 254203

    Juiz de Fora, Minas Gerais, 36010-570

  • Hospital de Clinicas de Porto Alegre /ID# 254916

    Porto Alegre, Rio Grande do Sul, 90035-903

  • LMK Sevicos Medicos S/S /ID# 254202

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 254917

    São José do Rio Preto, São Paulo, 15090-000

  • CEPIC - Centro Paulista de Investigacao Clinica /ID# 254200

    São Paulo, 04266-010

Other trials in Brazil

France6 sites

  • CHU Amiens-Picardie Site Sud /ID# 252384

    Amiens, Somme, 80054

  • CHU Montpellier - Hôpital Lapeyronie /ID# 252386

    Montpellier, Herault, 34090

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 254224

    Nice, Alpes-Maritimes, 06001

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252385

    Orléans, 45067

  • Hôpital Charles-Nicolle /ID# 252908

    Rouen, 76000

  • CHU Toulouse - Hopital Purpan /ID# 252402

    Toulouse, Haute-Garonne, 31059

Other trials in France

Serbia6 sites

  • Institute for Rheumatology /ID# 252333

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 252334

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 252335

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 252338

    Belgrade, Beograd, 11000

  • Special Hospital for Rheuma /ID# 252336

    Novi Sad, Vojvodina, 21000

  • Special Hospital for Rheuma /ID# 252339

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

Argentina5 sites

  • Organizacion Medica de Investigacion (OMI) /ID# 253253

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1015

  • Consultorios Reumatologicos Pampa /ID# 254095

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1428

  • Aprillus Asistencia e Investigacion /ID# 253258

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1958

  • Centro de Investigaciones Medicas Tucuman /ID# 253297

    San Miguel de Tucumán, Tucumán Province, 4000

  • CIMER Centro Integral de Medicina Respiratoria /ID# 255277

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Canada5 sites

  • Centre Rhumatologie de l'Est /ID# 254932

    Rimouski, Quebec, G5L 8W1

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 253409

    Sainte-Foy, Quebec, G1V 3M7

  • Dr. Latha Naik Medical Professional Corporation /ID# 254018

    Saskatoon, Saskatchewan, S7H 0P4

  • Centre de Recherche Musculo-Squelettique /ID# 256273

    Trois-Rivières, Quebec, G8Z 1Y2

  • Manitoba Clinic /ID# 254019

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Colombia5 sites

  • Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 252587

    Barranquilla, Atlántico, 80002

  • Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 252586

    Bogotá, Cundinamarca, 110221

  • Fundacion Oftalmologica de Santander - FOSCAL /ID# 252589

    Bucaramanga, Santander Department, 681004

  • Hospital Pablo Tobón Uribe /ID# 253371

    Medellín, Antioquia, 050034

  • Healthy Medical Center S.A.S /ID# 252585

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Croatia5 sites

  • Duplicate_Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455

    Krapinske Toplice, 49217

  • Medical Center Kuna-Peric /ID# 252452

    Zagreb, City of Zagreb, 10000

  • Poliklinika Bonifarm /ID# 252741

    Zagreb, City of Zagreb, 10000

  • Poliklinika Repromed /ID# 252451

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 252453

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Germany5 sites

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 252667

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 252670

    Herne, North Rhine-Westphalia, 44649

  • Klinische Forschung im med. Versorgungsalltag GbR /ID# 254221

    Planegg, 82152

  • Rheumazentrum Ratingen /ID# 252669

    Ratingen, 40882

  • Rheumatologische-Immunologische Praxis Templin /ID# 252863

    Templin, Brandenburg, 17268

Other trials in Germany

Mexico5 sites

  • Investigacion y Biomedicina de Chihuahua /ID# 253115

    Chihuahua City, 31000

  • Centro Integral en Reumatologia S.A de C.V /ID# 252872

    Guadalajara, Jalisco, 44160

  • Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253480

    Guadalajara, Jalisco, 44650

  • Hospital de Jesus /ID# 253114

    Mexico City, Mexico City, 06090

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 252873

    Mexico City, Mexico City, 11850

Other trials in Mexico

Romania5 sites

  • Spitalul Judetean de Urgenta Bacau /ID# 252860

    Bacau, 600114

  • Spitalul Clinic Sf. Maria /ID# 252759

    Bucharest, 011172

  • Spitalul Clinic Sf. Maria /ID# 253334

    Bucharest, 011172

  • Cabinet Medical Dr. Avram S.R.L /ID# 254133

    Timișoara, Timiș County, 300134

  • Banat Carina Med SRL /ID# 252757

    Timișoara, Timiș County, 300766

Other trials in Romania

South Korea5 sites

  • SoonChunHyang University Hospital Cheonan /ID# 254942

    Cheonan-si, Chungcheongnam-do, 31151

  • Chungnam National University Hospital /ID# 252159

    Daejeon, Daejeon Gwang Yeogsi, 35015

  • Chonnam National University Bitgoeul Hospital /ID# 254802

    Gwangju, Gwangju Gwang Yeogsi, 61748

  • Seoul National University Hospital /ID# 252160

    Seoul, Seoul Teugbyeolsi, 03080

  • Hanyang University Seoul Hospital /ID# 252161

    Seoul, Seoul Teugbyeolsi, 04763

Other trials in South Korea

Spain5 sites

  • Hospital Universitario Germans Trias i Pujol /ID# 254144

    Badalona, Barcelona, 08916

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425

    Sabadell, Barcelona, 08208

  • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 252430

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario y Politecnico La Fe /ID# 254143

    Valencia, 46026

  • Hospital Marina Baixa /ID# 254141

    Villajoyosa, Alicante, 03570

Other trials in Spain

Belgium4 sites

  • AZ Sint-Jan Brugge /ID# 252278

    Bruges, West-Vlaanderen, 8000

  • ReumaClinic /ID# 252277

    Genk, Limburg, 3600

  • UZ Gent /ID# 252306

    Ghent, Oost-Vlaanderen, 9000

  • Duplicate_CHU de Liege /ID# 252309

    Liège, 4000

Other trials in Belgium

Chile4 sites

  • Corporacion de Beneficiencia Osorno /ID# 252556

    Osorno, Los Lagos Region, 1710216

  • Centro Internacional de Estudios Clinicos - CIEC /ID# 252561

    Santiago, Region Metropolitana Santiago, 8420383

  • Complejo Asistencial Dr. Sotero del Rio /ID# 252559

    Santiago, Santiago Metropolitan, 8207257

  • Clinica Dermacross /ID# 252560

    Vitacura, Region Metropolitana Santiago, 7640881

Other trials in Chile

Hungary4 sites

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311

    Budapest, 1023

  • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400

    Székesfehérvár, 8000

  • MÁV Kórház /ID# 252628

    Szolnok, 5000

  • Vital-Medicina Kft. /ID# 252399

    Veszprém, Fejér, 8200

Other trials in Hungary

United Kingdom4 sites

  • The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301

    Kings Lynn, Norfolk, PE30 4ET

  • Royal Free Hospital /ID# 252297

    London, Greater London, NW3 2QG

  • Queen Mary University of London /ID# 252671

    London, EC1M 6BQ

  • Portsmouth Hospitals University NHS Trust /ID# 252772

    Portsmouth, PO6 3LY

Other trials in United Kingdom

Greece3 sites

  • General Hospital of Athens Laiko /ID# 252258

    Athens, Attica, 11527

  • University General Hospital Attikon /ID# 254751

    Athens, Attica, 12462

  • University General Hospital of Heraklion PA.G.N.I /ID# 252261

    Heraklion, Crete, 71500

Other trials in Greece

Italy3 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 252459

    Ancona, 60020

  • Azienda Ospedaliero Universitaria Careggi /ID# 252460

    Florence, Firenze, 50134

  • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 252461

    Milan, Milano, 20122

Other trials in Italy

Portugal3 sites

  • Hospital Garcia de Orta /ID# 252491

    Almada, Setúbal District, 2805-267

  • Unidade Local de Saude de Santa Maria, EPE /ID# 252492

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489

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

Other trials in Portugal

Puerto Rico2 sites

  • GCM Medical Group PSC /ID# 252700

    San Juan, 00917-3104

  • Mindful Medical Research /ID# 252693

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed.

Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world.

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Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Being tested
Upadacitinib, Adalimumab, Upadacitinib Matching Placebo, Adalimumab Matching Placebo
Keywords
Rheumatoid Arthritis, RA, Upadacitinib, Adalimumab, Methotrexate, MTX, TNF Inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • UpadacitinibDrug

    Also called RINVOQ

    Oral Tablets

  • AdalimumabDrug

    Also called Humira

    Subcutaneous Injection

  • Upadacitinib Matching PlaceboDrug

    Oral Tablets

  • Adalimumab Matching PlaceboDrug

    Subcutaneous Injection

Study groups in NCT05814627
Study groupRoleWhat they receive
Upadacitinib+ Adalimumab matching PlaceboExperimentalParticipants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Receives: Drug: Upadacitinib; Drug: Adalimumab Matching Placebo
Adalimumab + Upadacitinib matching PlaceboExperimentalParticipants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Receives: Drug: Adalimumab; Drug: Upadacitinib Matching Placebo

What is being measured

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

  1. Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2

    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 (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.

    Measured: Week 12

  2. Number of Participants with Adverse Events

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.

    Measured: From first dose of study drug until 70 days following last dose of study drug (up to approximately 58 weeks)

Secondary outcomes (5)

  1. Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

    • 50% improvement in tender joint count (TJC68);
    • 50% improvement in swollen joint count (SJC66); and
    • 50% improvement in at least 3 of the 5 following parameters:
    • Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS)
    • Patient's Global Assessment of Disease Activity (NRS)
    • Patient's Assessment of Pain (NRS)
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Week 12

  2. Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6

    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 (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.

    Measured: Week 12

  3. Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])

    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 (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.

    Measured: Week 12

  4. Change from Baseline in Participants Assessment of Pain

    Participants indicated their level of pain over the last 7 days using the Patient's Global Assessment Pain NRS. The range is 0 to 10 with no activity being indicated by 0 and severe activity by 10.

    Measured: Week 12

  5. Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score

    The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.

    Measured: 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 posted18 Apr 2023
  2. Study start15 Jun 2023
  3. Primary completion15 Jul 2026
  4. Study completion15 Jul 2026

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
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05814627
Sponsor's protocol ID
M23-700
Other IDs
2022-502578-18-00
Acronym
SELECT- SWITCH
Status last verified
Aug 2026
First submitted
4 Apr 2023
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Mysler E, Sidiropoulos PI, Balanescu A, Detert J, Xavier RM, Charles-Schoeman C, Bessette L, Crowley A, Kaneko Y, Zhang Z, Nagy O, Liu Y, Ren J, Romero AB, Suboticki JL, DeMasi R, Meerwein S, Fleischmann R; SELECT-SWITCH Study Investigators. Upadacitinib vs adalimumab in patients with rheumatoid arthritis and a prior inadequate response or intolerance to a tumour necrosis factor inhibitor: 12-week results from the randomised, double-blind, SELECT-SWITCH study. Ann Rheum Dis. 2026 Jul;85(7):1240-1254. doi: 10.1016/j.ard.2026.03.013. Epub 2026 Apr 15.

    PubMed 41991443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Upadacitinib and Adalimumab in people with Rheumatoid Arthritis, run by AbbVie at 218 sites in 25 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 8 inclusion and 4 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 218 sites in United States, Japan, China, Bulgaria, South Africa and 20 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2 (time frame: 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 NCT05814627, which also lists 1 linked publication.

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 14 Aug 2026.

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