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 (SELECT- SWITCH)

January 8, 2026 updated by: AbbVie

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Rheumatoid Arthritis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

487

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Buenos Aires F.D.
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1015
    - Organizacion Medica de Investigacion (OMI) /ID# 253253
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1428
    - Consultorios Reumatologicos Pampa /ID# 254095
  - Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina, 1958
    - Aprillus Asistencia e Investigacion /ID# 253258
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Centro de Investigaciones Medicas Tucuman /ID# 253297
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - CIMER Centro Integral de Medicina Respiratoria /ID# 255277
Belgium
- - Liège, Belgium, 4000
    - Duplicate_CHU de Liege /ID# 252309
- Limburg
  - Genk, Limburg, Belgium, 3600
    - ReumaClinic /ID# 252277
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - UZ Gent /ID# 252306
- West-Vlaanderen
  - Bruges, West-Vlaanderen, Belgium, 8000
    - AZ Sint-Jan Brugge /ID# 252278
Brazil
- - São Paulo, Brazil, 04266-010
    - CEPIC - Centro Paulista de Investigacao Clinica /ID# 254200
- Minas Gerais
  - Juiz de Fora, Minas Gerais, Brazil, 36010-570
    - CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 254203
- Paraná
  - Curitiba, Paraná, Brazil, 80030-110
    - CETI - Centro de Estudos em Terapias Inovadoras /ID# 254201
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre /ID# 254916
  - Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
    - LMK Sevicos Medicos S/S /ID# 254202
- São Paulo
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 254917
Bulgaria
- - Plovdiv, Bulgaria, 4023
    - Medical center Unimed /ID# 252344
  - Plovdiv, Bulgaria, 4027
    - MHAT Plovdiv /ID# 252342
  - Plovdiv, Bulgaria, 4001
    - Umbal Kaspela /ID# 252343
  - Sofia, Bulgaria, 1505
    - Diagnostic consultative center 17 Sofia /ID# 252341
  - Sofia, Bulgaria, 1606
    - Military Medical Academy Multiprofile Hospital /ID# 252355
- Sofia
  - Sofiya, Sofia, Bulgaria, 1463
    - Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252354
  - Sofiya, Sofia, Bulgaria, 1463
    - Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252555
Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1M3
    - Manitoba Clinic /ID# 254019
- Quebec
  - Rimouski, Quebec, Canada, G5L 8W1
    - Centre Rhumatologie de l'Est /ID# 254932
  - Sainte-Foy, Quebec, Canada, G1V 3M7
    - Groupe de Recherche en Maladies Osseuses Inc /ID# 253409
  - Trois-Rivières, Quebec, Canada, G8Z 1Y2
    - Centre de Recherche Musculo-Squelettique /ID# 256273
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7H 0P4
    - Dr. Latha Naik Medical Professional Corporation /ID# 254018
Chile
- Los Lagos Region
  - Osorno, Los Lagos Region, Chile, 1710216
    - Corporacion de Beneficiencia Osorno /ID# 252556
- Region Metropolitana Santiago
  - Santiago, Region Metropolitana Santiago, Chile, 8420383
    - Centro Internacional de Estudios Clinicos - CIEC /ID# 252561
  - Vitacura, Region Metropolitana Santiago, Chile, 7640881
    - Clinica Dermacross /ID# 252560
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 8207257
    - Complejo Asistencial Dr. Sotero del Rio /ID# 252559
China
- Anhui
  - Bengbu, Anhui, China, 233004
    - The first affiliated hospital of bengbu medical college /ID# 252612
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100034
    - Peking University First Hospital /ID# 252392
  - Beijing, Beijing Municipality, China, 100191
    - Peking University Third Hospital /ID# 252393
- Guangdong
  - Guangzhou, Guangdong, China, 510630
    - The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252394
- Hunan
  - Zhuzhou, Hunan, China, 412007
    - Zhuzhou Central Hospital /ID# 252390
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Nanjing Drum Tower Hospital /ID# 252613
- Jiangxi
  - Pingxiang, Jiangxi, China, 337055
    - Jiangxi Pingxiang Peoples Hospital /ID# 252381
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - West China Hospital, Sichuan University /ID# 252364
Colombia
- Antioquia
  - Medellín, Antioquia, Colombia, 050034
    - Hospital Pablo Tobón Uribe /ID# 253371
- Atlántico
  - Barranquilla, Atlántico, Colombia, 80002
    - Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 252587
- Cundinamarca
  - Bogotá, Cundinamarca, Colombia, 110221
    - Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 252586
  - Zipaquirá, Cundinamarca, Colombia, 250252
    - Healthy Medical Center S.A.S /ID# 252585
- Santander Department
  - Bucaramanga, Santander Department, Colombia, 681004
    - Fundacion Oftalmologica de Santander - FOSCAL /ID# 252589
Croatia
- - Krapinske Toplice, Croatia, 49217
    - Duplicate_Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Medical Center Kuna-Peric /ID# 252452
  - Zagreb, City of Zagreb, Croatia, 10000
    - Poliklinika Bonifarm /ID# 252741
  - Zagreb, City of Zagreb, Croatia, 10000
    - Poliklinika Repromed /ID# 252451
  - Zagreb, City of Zagreb, Croatia, 10000
    - Poliklinika Solmed /ID# 252453
France
- - Orléans, France, 45067
    - Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252385
  - Rouen, France, 76000
    - Hôpital Charles-Nicolle /ID# 252908
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06001
    - Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 254224
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31059
    - CHU Toulouse - Hopital Purpan /ID# 252402
- Herault
  - Montpellier, Herault, France, 34090
    - CHU Montpellier - Hôpital Lapeyronie /ID# 252386
- Somme
  - Amiens, Somme, France, 80054
    - CHU Amiens-Picardie Site Sud /ID# 252384
Germany
- - Hamburg, Germany, 20095
    - MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 252667
  - Planegg, Germany, 82152
    - Klinische Forschung im med. Versorgungsalltag GbR /ID# 254221
  - Ratingen, Germany, 40882
    - Rheumazentrum Ratingen /ID# 252669
- Brandenburg
  - Templin, Brandenburg, Germany, 17268
    - Rheumatologische-Immunologische Praxis Templin /ID# 252863
- North Rhine-Westphalia
  - Herne, North Rhine-Westphalia, Germany, 44649
    - Rheumazentrum Ruhrgebiet /ID# 252670
Greece
- Attica
  - Athens, Attica, Greece, 11527
    - General Hospital of Athens Laiko /ID# 252258
  - Athens, Attica, Greece, 12462
    - University General Hospital Attikon /ID# 254751
- Crete
  - Heraklion, Crete, Greece, 71500
    - University General Hospital of Heraklion PA.G.N.I /ID# 252261
Hungary
- - Budapest, Hungary, 1023
    - Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311
  - Szolnok, Hungary, 5000
    - MÁV Kórház /ID# 252628
  - Székesfehérvár, Hungary, 8000
    - CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400
- Fejér
  - Veszprém, Fejér, Hungary, 8200
    - Vital-Medicina Kft. /ID# 252399
Italy
- - Ancona, Italy, 60020
    - Azienda Ospedaliero Universitaria delle Marche /ID# 252459
- Firenze
  - Florence, Firenze, Italy, 50134
    - Azienda Ospedaliero Universitaria Careggi /ID# 252460
- Milano
  - Milan, Milano, Italy, 20122
    - ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 252461
Japan
- - Toyama, Japan, 930-0975
    - Toyama Prefectural Central Hospital /ID# 270871
  - Ōita, Japan, 870-0823
    - Maeshima Rheumatology Clinic /ID# 270448
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 455-8530
    - Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836
  - Nagoya, Aichi-ken, Japan, 457-8511
    - Daido Clinic - Nagoya /ID# 253058
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8551
    - Kashiwa Kousei General Hospital /ID# 270033
- Fukui
  - Fukui-shi, Fukui, Japan, 910-0068
    - Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 810-8539
    - Hamanomachi Hospital /ID# 253168
  - Fukuoka, Fukuoka, Japan, 814-0002
    - Shono Rheumatism Clinic /ID# 252591
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 078-8243
    - Katayama Orthopedic Rheumatology Clinic /ID# 252746
  - Sapporo, Hokkaido, Japan, 060-0001
    - Sagawa Akira Rheumatology Clin /ID# 252773
  - Sapporo, Hokkaido, Japan, 063-0811
    - Hokkaido Medical Center For Rheumatic Diseases /ID# 270019
- Hyōgo
  - Kato-shi, Hyōgo, Japan, 673-1462
    - Matsubara Mayflower Hospital /ID# 252834
- Kagawa-ken
  - Sanuki-shi, Kagawa-ken, Japan, 769-2393
    - Sanuki Municipal Hospital /ID# 252747
- Kochi
  - Kochi, Kochi, Japan, 781-0112
    - Bay Side Misato Medical Center /ID# 252661
- Kumamoto
  - Kumamoto, Kumamoto, Japan, 8620975
    - Kumamoto Orthopaedic Hospital /ID# 253167
- Miyazaki
  - Miyazaki, Miyazaki, Japan, 880-0053
    - Medical Corporation Keiai Kai Clinic /ID# 252750
- Nagasaki
  - Sasebo-shi, Nagasaki, Japan, 857-1195
    - Sasebo Chuo Hospital /ID# 252662
- Osaka
  - Izumisano, Osaka, Japan, 598-0048
    - Rinku Hashimoto Rheumatology Orthopaedics /ID# 270396
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-8560
    - St. Lukes International Hospital /ID# 253131
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital /ID# 253205
- Yamaguchi
  - Shimonoseki-shi, Yamaguchi, Japan, 752-0976
    - Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057
Mexico
- - Chihuahua City, Mexico, 31000
    - Investigacion y Biomedicina de Chihuahua /ID# 253115
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44160
    - Centro Integral en Reumatologia S.A de C.V /ID# 252872
  - Guadalajara, Jalisco, Mexico, 44650
    - Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253480
- Mexico City
  - Mexico City, Mexico City, Mexico, 06090
    - Hospital de Jesus /ID# 253114
  - Mexico City, Mexico City, Mexico, 11850
    - CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 252873
Portugal
- - Lisbon, Portugal, 1649-035
    - Unidade Local de Saude de Santa Maria, EPE /ID# 252492
- Setúbal District
  - Almada, Setúbal District, Portugal, 2805-267
    - Hospital Garcia de Orta /ID# 252491
- Viana do Castelo District
  - Ponte de Lima, Viana do Castelo District, Portugal, 4990-041
    - Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489
Puerto Rico
- - San Juan, Puerto Rico, 00917-3104
    - GCM Medical Group PSC /ID# 252700
  - San Juan, Puerto Rico, 00918-3756
    - Mindful Medical Research /ID# 252693
Romania
- - Bacau, Romania, 600114
    - Spitalul Judetean de Urgenta Bacau /ID# 252860
  - Bucharest, Romania, 011172
    - Spitalul Clinic Sf. Maria /ID# 252759
  - Bucharest, Romania, 011172
    - Spitalul Clinic Sf. Maria /ID# 253334
- Timiș County
  - Timișoara, Timiș County, Romania, 300134
    - Cabinet Medical Dr. Avram S.R.L /ID# 254133
  - Timișoara, Timiș County, Romania, 300766
    - Banat Carina Med SRL /ID# 252757
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Institute for Rheumatology /ID# 252333
  - Belgrade, Beograd, Serbia, 11000
    - Institute for Rheumatology /ID# 252334
  - Belgrade, Beograd, Serbia, 11000
    - Institute for Rheumatology /ID# 252335
  - Belgrade, Beograd, Serbia, 11000
    - Institute for Rheumatology /ID# 252338
- Vojvodina
  - Novi Sad, Vojvodina, Serbia, 21000
    - Special Hospital for Rheuma /ID# 252336
  - Novi Sad, Vojvodina, Serbia, 21000
    - Special Hospital for Rheuma /ID# 252339
South Africa
- Gauteng
  - Pretoria, Gauteng, South Africa, 0001
    - University of Pretoria /ID# 252368
  - Pretoria, Gauteng, South Africa, 0002
    - Dr Elsa van Duuren /ID# 252387
  - Pretoria, Gauteng, South Africa, 0002
    - Emmed Research cc /ID# 254317
- KwaZulu-Natal
  - Umhlanga, KwaZulu-Natal, South Africa, 4319
    - Dr Asokan Naidoo /ID# 252894
- Western Cape
  - Cape Town, Western Cape, South Africa, 7130
    - Winelands Medical Research - Somerset West /ID# 252745
  - Cape Town, Western Cape, South Africa, 7405
    - Arthritis Clinical Research Trials /ID# 252370
  - Stellenbosch, Western Cape, South Africa, 7600
    - Winelands Medical Research Centre /ID# 252369
South Korea
- Chungcheongnam-do
  - Cheonan-si, Chungcheongnam-do, South Korea, 31151
    - SoonChunHyang University Hospital Cheonan /ID# 254942
- Daejeon Gwang Yeogsi
  - Daejeon, Daejeon Gwang Yeogsi, South Korea, 35015
    - Chungnam National University Hospital /ID# 252159
- Gwangju Gwang Yeogsi
  - Gwangju, Gwangju Gwang Yeogsi, South Korea, 61748
    - Chonnam National University Bitgoeul Hospital /ID# 254802
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, South Korea, 03080
    - Seoul National University Hospital /ID# 252160
  - Seoul, Seoul Teugbyeolsi, South Korea, 04763
    - Hanyang University Seoul Hospital /ID# 252161
Spain
- - Valencia, Spain, 46026
    - Hospital Universitario y Politecnico La Fe /ID# 254143
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 252430
- Alicante
  - Villajoyosa, Alicante, Spain, 03570
    - Hospital Marina Baixa /ID# 254141
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Universitario Germans Trias i Pujol /ID# 254144
  - Sabadell, Barcelona, Spain, 08208
    - Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425
United Kingdom
- - London, United Kingdom, EC1M 6BQ
    - Queen Mary University of London /ID# 252671
  - Portsmouth, United Kingdom, PO6 3LY
    - Portsmouth Hospitals University NHS Trust /ID# 252772
- Greater London
  - London, Greater London, United Kingdom, NW3 2QG
    - Royal Free Hospital /ID# 252297
- Norfolk
  - Kings Lynn, Norfolk, United Kingdom, PE30 4ET
    - The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301
United States
- Arizona
  - Flagstaff, Arizona, United States, 86001-6299
    - AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431
  - Glendale, Arizona, United States, 85306-9802
    - Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
  - Peoria, Arizona, United States, 85381
    - Sun Valley Arthritis Center Ltd. /ID# 254654
  - Phoenix, Arizona, United States, 85032
    - Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432
  - Phoenix, Arizona, United States, 85032
    - Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021
  - Tucson, Arizona, United States, 85704
    - Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
- Arkansas
  - Jonesboro, Arkansas, United States, 72401-6251
    - Arthritis and Rheumatism Associates /ID# 254013
- California
  - Fullerton, California, United States, 92835
    - Providence - St. Jude Medical Center /ID# 252690
  - Huntington Beach, California, United States, 92648-5994
    - Newport Huntington Medical Group /ID# 252687
  - La Mesa, California, United States, 91942
    - Purushotham & Akther Kotha MD, Inc /ID# 252704
  - Los Alamitos, California, United States, 90720-5402
    - Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692
  - San Diego, California, United States, 92128-2549
    - Rheumatology Center of San Diego /ID# 255038
  - Thousand Oaks, California, United States, 91360-3951
    - Millennium Clinical Trials /ID# 252689
  - Torrance, California, United States, 90502
    - The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691
  - Woodland Hills, California, United States, 91364
    - Comprehensive Rheumatology Center /ID# 252688
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital /ID# 254617
  - Denver, Colorado, United States, 80230
    - Denver Arthritis Clinic /ID# 254058
  - Fort Collins, Colorado, United States, 80528
    - Tekton Research - Fort Collins - East Harmony Road /ID# 255036
- Florida
  - Aventura, Florida, United States, 33180
    - Arthritis and Rheumatic Disease Specialties /ID# 260583
  - Boca Raton, Florida, United States, 33486
    - Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733
  - Brandon, Florida, United States, 33511
    - Bay Area Arthritis and Osteo /ID# 254046
  - Coral Springs, Florida, United States, 33065
    - Believe Clinical Trial /ID# 262355
  - Daytona Beach, Florida, United States, 32117
    - International Medical Research /ID# 254651
  - DeBary, Florida, United States, 32713-2260
    - Omega Research Debary, LLC /ID# 253735
  - Hialeah, Florida, United States, 33016-1897
    - Neoclinical Research /ID# 254622
  - Hollywood, Florida, United States, 33024
    - Gnp Research - Hollywood /ID# 273563
  - Margate, Florida, United States, 33063
    - Life Clinical Trials /ID# 256061
  - Miami, Florida, United States, 33014
    - Lakes Research, LLC /ID# 255023
  - Orlando, Florida, United States, 32819
    - HMD Research LLC /ID# 253732
  - Ormond Beach, Florida, United States, 32174
    - Millennium Research /ID# 253744
  - Palm Beach Gardens, Florida, United States, 33410
    - Vitalia Research /ID# 274213
  - St. Petersburg, Florida, United States, 33705
    - BayCare Medical Group /ID# 253799
  - Tampa, Florida, United States, 33606
    - Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 254649
  - Tampa, Florida, United States, 33606
    - Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 255264
  - Tampa, Florida, United States, 33613
    - University of South Florida- Neuroscience Institute /ID# 253745
  - Tampa, Florida, United States, 33614
    - Baycare Medical Group - Tampa /ID# 255268
- Georgia
  - Marietta, Georgia, United States, 30060
    - Atlanta Research Center For Rheumatology - Marietta /ID# 254623
- Illinois
  - Chicago, Illinois, United States, 60616
    - Next Innovative Clinical Research - Chicago /ID# 273453
  - Libertyville, Illinois, United States, 60048
    - Deerbrook Medical Associates /ID# 254008
  - Rockford, Illinois, United States, 61114-4937
    - OrthoIllinois /ID# 254057
  - Schaumburg, Illinois, United States, 60195-3106
    - Greater Chicago Specialty Physicians /ID# 254000
  - Skokie, Illinois, United States, 60076
    - Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999
  - Willowbrook, Illinois, United States, 60527
    - Willow Rheumatology and Wellness, PLLC /ID# 254712
- Indiana
  - Evansville, Indiana, United States, 47715-2813
    - Qualmedica Research - Evansville /ID# 254005
- Kentucky
  - Hopkinsville, Kentucky, United States, 42240
    - Western KY Rheumatology /ID# 255026
  - Lexington, Kentucky, United States, 40504
    - Bluegrass Community Research /ID# 254653
- Louisiana
  - Baton Rouge, Louisiana, United States, 70836
    - Ochsner Health Center - The Grove /ID# 254059
  - Monroe, Louisiana, United States, 71203
    - The Arthritis & Diabetes Clinic, Inc. /ID# 254014
- Maine
  - Portland, Maine, United States, 04102-2643
    - Rheumatology Associates PA - Portland /ID# 255014
- Massachusetts
  - Boston, Massachusetts, United States, 02149-4903
    - Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029
- Michigan
  - Grand Blanc, Michigan, United States, 48439
    - AA Medical Research Center - Grand Blanc /ID# 254007
  - Okemos, Michigan, United States, 48910
    - Advanced Rheumatology, PC /ID# 256059
- Minnesota
  - Eagan, Minnesota, United States, 55121
    - St. Paul Rheumatology, PA /ID# 255037
- Mississippi
  - Hattiesburg, Mississippi, United States, 39402
    - Arthritis Associates /ID# 253992
- Missouri
  - Kansas City, Missouri, United States, 64151
    - Kansas City Physician Partners /ID# 255035
  - Springfield, Missouri, United States, 65807
    - Clinvest Research LLC /ID# 254054
- Montana
  - Kalispell, Montana, United States, 59901
    - Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 253738
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Physician Research Collaboration, LLC /ID# 254012
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth-Hitchcock Medical Center /ID# 253798
- New Jersey
  - Voorhees Township, New Jersey, United States, 08043
    - Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266
- New Mexico
  - Las Cruces, New Mexico, United States, 88011
    - Arthritis and Osteoporosis Associates of New Mexico /ID# 252684
- New York
  - Brooklyn, New York, United States, 11201
    - NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Joint And Muscle Research Institute /ID# 275128
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Health Med Arts Clinic /ID# 254010
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Paramount Medical Research and Consulting /ID# 254048
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73116-7226
    - Rheumatology Associates of Oklahoma /ID# 253994
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19114
    - Clinical Research of Philadelphia, LLC /ID# 255025
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - West Tennessee Research Institute /ID# 254620
- Texas
  - Allen, Texas, United States, 75013-6147
    - Arthritis and Rheumatology Research Institute, PLLC /ID# 254045
  - Austin, Texas, United States, 78745
    - Tekton Research, L.L.C /ID# 254004
  - Carrollton, Texas, United States, 75007
    - Trinity Universal Research Associates - Carrollton /ID# 254648
  - Corpus Christi, Texas, United States, 78404
    - Adriana Pop-Moody MD Clinic PA /ID# 255030
  - Fort Worth, Texas, United States, 76104-4917
    - JPS Rheumatology Clinic /ID# 254050
  - Houston, Texas, United States, 77043
    - Biopharma Informatic - Houston - Business Center Drive /ID# 254051
  - Houston, Texas, United States, 77089-6142
    - Accurate Clinical Research - Houston /ID# 254647
  - Houston, Texas, United States, 77089
    - Research Physicians Network, LLC /ID# 254053
  - Katy, Texas, United States, 77450-2244
    - R & H Clinical Research - 777 Katy /ID# 255024
  - Lubbock, Texas, United States, 79424
    - West Texas Clinical Research /ID# 253736
  - Plano, Texas, United States, 75024-5283
    - Trinity Universal Research Associates, Inc /ID# 253995
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute /ID# 255019
  - The Woodlands, Texas, United States, 77382
    - Advanced Rheumatology of Houston /ID# 254003
  - Tomball, Texas, United States, 77375
    - DM Clinical Research - Tomball /ID# 254001
  - Tomball, Texas, United States, 77377
    - Rheumatology Clinic of Houston /ID# 254002
- Wisconsin
  - Franklin, Wisconsin, United States, 53132
    - Aurora Rheumatology and Immunotherapy Center /ID# 254049
  - Glendale, Wisconsin, United States, 53217
    - Rheumatic Disease Center, LLP /ID# 254015

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upadacitinib+ Adalimumab matching Placebo Participants 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.	Drug: Upadacitinib Oral Tablets Other Names: RINVOQ Drug: Adalimumab Matching Placebo Subcutaneous Injection
Experimental: Adalimumab + Upadacitinib matching Placebo Participants 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.	Drug: Adalimumab Subcutaneous Injection Other Names: Humira Drug: Upadacitinib Matching Placebo Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2 Time Frame: 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 (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.	Week 12
Number of Participants with Adverse Events Time Frame: From first dose of study drug until 70 days following last dose of study drug (up to approximately 58 weeks)	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.	From first dose of study drug until 70 days following last dose of study drug (up to approximately 58 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response Time Frame: Week 12	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).	Week 12
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6 Time Frame: 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 (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.	Week 12
Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) Time Frame: 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 (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.	Week 12
Change from Baseline in Participants Assessment of Pain Time Frame: Week 12	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.	Week 12
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Time Frame: Week 12	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.	Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M23-700
2022-502578-18-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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