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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
Sponsor: AbbVie
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 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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
487
Start Date
2023-06-15
Completion Date
2026-07
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Upadacitinib
Oral Tablets
Adalimumab
Subcutaneous Injection
Upadacitinib Matching Placebo
Oral Tablets
Adalimumab Matching Placebo
Subcutaneous Injection
Locations (218)
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431
Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
Glendale, Arizona, United States
Sun Valley Arthritis Center Ltd. /ID# 254654
Peoria, Arizona, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021
Phoenix, Arizona, United States
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
Tucson, Arizona, United States
Arthritis and Rheumatism Associates /ID# 254013
Jonesboro, Arkansas, United States
Providence - St. Jude Medical Center /ID# 252690
Fullerton, California, United States
Newport Huntington Medical Group /ID# 252687
Huntington Beach, California, United States
Purushotham & Akther Kotha MD, Inc /ID# 252704
La Mesa, California, United States
Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692
Los Alamitos, California, United States
Rheumatology Center of San Diego /ID# 255038
San Diego, California, United States
Millennium Clinical Trials /ID# 252689
Thousand Oaks, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691
Torrance, California, United States
Comprehensive Rheumatology Center /ID# 252688
Woodland Hills, California, United States
University of Colorado Hospital /ID# 254617
Aurora, Colorado, United States
Denver Arthritis Clinic /ID# 254058
Denver, Colorado, United States
Tekton Research - Fort Collins - East Harmony Road /ID# 255036
Fort Collins, Colorado, United States
Arthritis and Rheumatic Disease Specialties /ID# 260583
Aventura, Florida, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733
Boca Raton, Florida, United States
Bay Area Arthritis and Osteo /ID# 254046
Brandon, Florida, United States
Believe Clinical Trial /ID# 262355
Coral Springs, Florida, United States
International Medical Research /ID# 254651
Daytona Beach, Florida, United States
Omega Research Debary, LLC /ID# 253735
DeBary, Florida, United States
Neoclinical Research /ID# 254622
Hialeah, Florida, United States
Gnp Research - Hollywood /ID# 273563
Hollywood, Florida, United States
Life Clinical Trials /ID# 256061
Margate, Florida, United States
Lakes Research, LLC /ID# 255023
Miami, Florida, United States
HMD Research LLC /ID# 253732
Orlando, Florida, United States
Millennium Research /ID# 253744
Ormond Beach, Florida, United States
Vitalia Research /ID# 274213
Palm Beach Gardens, Florida, United States
BayCare Medical Group /ID# 253799
St. Petersburg, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 254649
Tampa, Florida, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 255264
Tampa, Florida, United States
University of South Florida- Neuroscience Institute /ID# 253745
Tampa, Florida, United States
Baycare Medical Group - Tampa /ID# 255268
Tampa, Florida, United States
Atlanta Research Center For Rheumatology - Marietta /ID# 254623
Marietta, Georgia, United States
Next Innovative Clinical Research - Chicago /ID# 273453
Chicago, Illinois, United States
Deerbrook Medical Associates /ID# 254008
Libertyville, Illinois, United States
OrthoIllinois /ID# 254057
Rockford, Illinois, United States
Greater Chicago Specialty Physicians /ID# 254000
Schaumburg, Illinois, United States
Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999
Skokie, Illinois, United States
Willow Rheumatology and Wellness, PLLC /ID# 254712
Willowbrook, Illinois, United States
Qualmedica Research - Evansville /ID# 254005
Evansville, Indiana, United States
Western KY Rheumatology /ID# 255026
Hopkinsville, Kentucky, United States
Bluegrass Community Research /ID# 254653
Lexington, Kentucky, United States
Ochsner Health Center - The Grove /ID# 254059
Baton Rouge, Louisiana, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 254014
Monroe, Louisiana, United States
Rheumatology Associates PA - Portland /ID# 255014
Portland, Maine, United States
Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029
Boston, Massachusetts, United States
AA Medical Research Center - Grand Blanc /ID# 254007
Grand Blanc, Michigan, United States
Advanced Rheumatology, PC /ID# 256059
Okemos, Michigan, United States
St. Paul Rheumatology, PA /ID# 255037
Eagan, Minnesota, United States
Arthritis Associates /ID# 253992
Hattiesburg, Mississippi, United States
Kansas City Physician Partners /ID# 255035
Kansas City, Missouri, United States
Clinvest Research LLC /ID# 254054
Springfield, Missouri, United States
Logan Health Research - Glacier View Research Institute - Rheumatology /ID# 253738
Kalispell, Montana, United States
Physician Research Collaboration, LLC /ID# 254012
Lincoln, Nebraska, United States
Dartmouth-Hitchcock Medical Center /ID# 253798
Lebanon, New Hampshire, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266
Voorhees Township, New Jersey, United States
Arthritis and Osteoporosis Associates of New Mexico /ID# 252684
Las Cruces, New Mexico, United States
NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621
Brooklyn, New York, United States
Joint And Muscle Research Institute /ID# 275128
Charlotte, North Carolina, United States
Trinity Health Med Arts Clinic /ID# 254010
Minot, North Dakota, United States
Paramount Medical Research and Consulting /ID# 254048
Middleburg Heights, Ohio, United States
Rheumatology Associates of Oklahoma /ID# 253994
Oklahoma City, Oklahoma, United States
Clinical Research of Philadelphia, LLC /ID# 255025
Philadelphia, Pennsylvania, United States
West Tennessee Research Institute /ID# 254620
Jackson, Tennessee, United States
Arthritis and Rheumatology Research Institute, PLLC /ID# 254045
Allen, Texas, United States
Tekton Research, L.L.C /ID# 254004
Austin, Texas, United States
Trinity Universal Research Associates - Carrollton /ID# 254648
Carrollton, Texas, United States
Adriana Pop-Moody MD Clinic PA /ID# 255030
Corpus Christi, Texas, United States
JPS Rheumatology Clinic /ID# 254050
Fort Worth, Texas, United States
Biopharma Informatic - Houston - Business Center Drive /ID# 254051
Houston, Texas, United States
Accurate Clinical Research - Houston /ID# 254647
Houston, Texas, United States
Research Physicians Network, LLC /ID# 254053
Houston, Texas, United States
R & H Clinical Research - 777 Katy /ID# 255024
Katy, Texas, United States
West Texas Clinical Research /ID# 253736
Lubbock, Texas, United States
Trinity Universal Research Associates, Inc /ID# 253995
Plano, Texas, United States
Sun Research Institute /ID# 255019
San Antonio, Texas, United States
Advanced Rheumatology of Houston /ID# 254003
The Woodlands, Texas, United States
DM Clinical Research - Tomball /ID# 254001
Tomball, Texas, United States
Rheumatology Clinic of Houston /ID# 254002
Tomball, Texas, United States
Aurora Rheumatology and Immunotherapy Center /ID# 254049
Franklin, Wisconsin, United States
Rheumatic Disease Center, LLP /ID# 254015
Glendale, Wisconsin, United States
Organizacion Medica de Investigacion (OMI) /ID# 253253
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Consultorios Reumatologicos Pampa /ID# 254095
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Aprillus Asistencia e Investigacion /ID# 253258
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina
Centro de Investigaciones Medicas Tucuman /ID# 253297
San Miguel de Tucumán, Tucumán Province, Argentina
CIMER Centro Integral de Medicina Respiratoria /ID# 255277
San Miguel de Tucumán, Tucumán Province, Argentina
ReumaClinic /ID# 252277
Genk, Limburg, Belgium
UZ Gent /ID# 252306
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge /ID# 252278
Bruges, West-Vlaanderen, Belgium
Duplicate_CHU de Liege /ID# 252309
Liège, Belgium
CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 254203
Juiz de Fora, Minas Gerais, Brazil
CETI - Centro de Estudos em Terapias Inovadoras /ID# 254201
Curitiba, Paraná, Brazil
Hospital de Clinicas de Porto Alegre /ID# 254916
Porto Alegre, Rio Grande do Sul, Brazil
LMK Sevicos Medicos S/S /ID# 254202
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 254917
São José do Rio Preto, São Paulo, Brazil
CEPIC - Centro Paulista de Investigacao Clinica /ID# 254200
São Paulo, Brazil
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252354
Sofiya, Sofia, Bulgaria
Diagnostic Consultative Centre (Dcc) - Foкus 5 /ID# 252555
Sofiya, Sofia, Bulgaria
Umbal Kaspela /ID# 252343
Plovdiv, Bulgaria
Medical center Unimed /ID# 252344
Plovdiv, Bulgaria
MHAT Plovdiv /ID# 252342
Plovdiv, Bulgaria
Diagnostic consultative center 17 Sofia /ID# 252341
Sofia, Bulgaria
Military Medical Academy Multiprofile Hospital /ID# 252355
Sofia, Bulgaria
Manitoba Clinic /ID# 254019
Winnipeg, Manitoba, Canada
Centre Rhumatologie de l'Est /ID# 254932
Rimouski, Quebec, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 253409
Sainte-Foy, Quebec, Canada
Centre de Recherche Musculo-Squelettique /ID# 256273
Trois-Rivières, Quebec, Canada
Dr. Latha Naik Medical Professional Corporation /ID# 254018
Saskatoon, Saskatchewan, Canada
Corporacion de Beneficiencia Osorno /ID# 252556
Osorno, Los Lagos Region, Chile
Centro Internacional de Estudios Clinicos - CIEC /ID# 252561
Santiago, Region Metropolitana Santiago, Chile
Clinica Dermacross /ID# 252560
Vitacura, Region Metropolitana Santiago, Chile
Complejo Asistencial Dr. Sotero del Rio /ID# 252559
Santiago, Santiago Metropolitan, Chile
The first affiliated hospital of bengbu medical college /ID# 252612
Bengbu, Anhui, China
Peking University First Hospital /ID# 252392
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 252393
Beijing, Beijing Municipality, China
The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252394
Guangzhou, Guangdong, China
Zhuzhou Central Hospital /ID# 252390
Zhuzhou, Hunan, China
Nanjing Drum Tower Hospital /ID# 252613
Nanjing, Jiangsu, China
Jiangxi Pingxiang Peoples Hospital /ID# 252381
Pingxiang, Jiangxi, China
West China Hospital, Sichuan University /ID# 252364
Chengdu, Sichuan, China
Hospital Pablo Tobón Uribe /ID# 253371
Medellín, Antioquia, Colombia
Centro Integral de Reumatología del Caribe SAS - Circaribe SAS /ID# 252587
Barranquilla, Atlántico, Colombia
Centro de Investigacion en Reumatologia y especialidades Medicas S.A.S- CIREEM /ID# 252586
Bogotá, Cundinamarca, Colombia
Healthy Medical Center S.A.S /ID# 252585
Zipaquirá, Cundinamarca, Colombia
Fundacion Oftalmologica de Santander - FOSCAL /ID# 252589
Bucaramanga, Santander Department, Colombia
Medical Center Kuna-Peric /ID# 252452
Zagreb, City of Zagreb, Croatia
Poliklinika Bonifarm /ID# 252741
Zagreb, City of Zagreb, Croatia
Poliklinika Repromed /ID# 252451
Zagreb, City of Zagreb, Croatia
Poliklinika Solmed /ID# 252453
Zagreb, City of Zagreb, Croatia
Duplicate_Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455
Krapinske Toplice, Croatia
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 254224
Nice, Alpes-Maritimes, France
CHU Toulouse - Hopital Purpan /ID# 252402
Toulouse, Haute-Garonne, France
CHU Montpellier - Hôpital Lapeyronie /ID# 252386
Montpellier, Herault, France
CHU Amiens-Picardie Site Sud /ID# 252384
Amiens, Somme, France
Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252385
Orléans, France
Hôpital Charles-Nicolle /ID# 252908
Rouen, France
Rheumatologische-Immunologische Praxis Templin /ID# 252863
Templin, Brandenburg, Germany
Rheumazentrum Ruhrgebiet /ID# 252670
Herne, North Rhine-Westphalia, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 252667
Hamburg, Germany
Klinische Forschung im med. Versorgungsalltag GbR /ID# 254221
Planegg, Germany
Rheumazentrum Ratingen /ID# 252669
Ratingen, Germany
General Hospital of Athens Laiko /ID# 252258
Athens, Attica, Greece
University General Hospital Attikon /ID# 254751
Athens, Attica, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 252261
Heraklion, Crete, Greece
Vital-Medicina Kft. /ID# 252399
Veszprém, Fejér, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311
Budapest, Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400
Székesfehérvár, Hungary
MÁV Kórház /ID# 252628
Szolnok, Hungary
Azienda Ospedaliero Universitaria Careggi /ID# 252460
Florence, Firenze, Italy
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 252461
Milan, Milano, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 252459
Ancona, Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836
Nagoya, Aichi-ken, Japan
Daido Clinic - Nagoya /ID# 253058
Nagoya, Aichi-ken, Japan
Kashiwa Kousei General Hospital /ID# 270033
Kashiwa-shi, Chiba, Japan
Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774
Fukui-shi, Fukui, Japan
Hamanomachi Hospital /ID# 253168
Fukuoka, Fukuoka, Japan
Shono Rheumatism Clinic /ID# 252591
Fukuoka, Fukuoka, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 252746
Asahikawa-shi, Hokkaido, Japan
Sagawa Akira Rheumatology Clin /ID# 252773
Sapporo, Hokkaido, Japan
Hokkaido Medical Center For Rheumatic Diseases /ID# 270019
Sapporo, Hokkaido, Japan
Matsubara Mayflower Hospital /ID# 252834
Kato-shi, Hyōgo, Japan
Sanuki Municipal Hospital /ID# 252747
Sanuki-shi, Kagawa-ken, Japan
Bay Side Misato Medical Center /ID# 252661
Kochi, Kochi, Japan
Kumamoto Orthopaedic Hospital /ID# 253167
Kumamoto, Kumamoto, Japan
Medical Corporation Keiai Kai Clinic /ID# 252750
Miyazaki, Miyazaki, Japan
Sasebo Chuo Hospital /ID# 252662
Sasebo-shi, Nagasaki, Japan
Rinku Hashimoto Rheumatology Orthopaedics /ID# 270396
Izumisano, Osaka, Japan
St. Lukes International Hospital /ID# 253131
Chuo-ku, Tokyo, Japan
Keio University Hospital /ID# 253205
Shinjuku-ku, Tokyo, Japan
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057
Shimonoseki-shi, Yamaguchi, Japan
Maeshima Rheumatology Clinic /ID# 270448
Ōita, Japan
Toyama Prefectural Central Hospital /ID# 270871
Toyama, Japan
Centro Integral en Reumatologia S.A de C.V /ID# 252872
Guadalajara, Jalisco, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 253480
Guadalajara, Jalisco, Mexico
Hospital de Jesus /ID# 253114
Mexico City, Mexico City, Mexico
CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 252873
Mexico City, Mexico City, Mexico
Investigacion y Biomedicina de Chihuahua /ID# 253115
Chihuahua City, Mexico
Hospital Garcia de Orta /ID# 252491
Almada, Setúbal District, Portugal
Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489
Ponte de Lima, Viana do Castelo District, Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 252492
Lisbon, Portugal
GCM Medical Group PSC /ID# 252700
San Juan, Puerto Rico
Mindful Medical Research /ID# 252693
San Juan, Puerto Rico
Cabinet Medical Dr. Avram S.R.L /ID# 254133
Timișoara, Timiș County, Romania
Banat Carina Med SRL /ID# 252757
Timișoara, Timiș County, Romania
Spitalul Judetean de Urgenta Bacau /ID# 252860
Bacau, Romania
Spitalul Clinic Sf. Maria /ID# 252759
Bucharest, Romania
Spitalul Clinic Sf. Maria /ID# 253334
Bucharest, Romania
Institute for Rheumatology /ID# 252333
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 252334
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 252335
Belgrade, Beograd, Serbia
Institute for Rheumatology /ID# 252338
Belgrade, Beograd, Serbia
Special Hospital for Rheuma /ID# 252336
Novi Sad, Vojvodina, Serbia
Special Hospital for Rheuma /ID# 252339
Novi Sad, Vojvodina, Serbia
University of Pretoria /ID# 252368
Pretoria, Gauteng, South Africa
Dr Elsa van Duuren /ID# 252387
Pretoria, Gauteng, South Africa
Emmed Research cc /ID# 254317
Pretoria, Gauteng, South Africa
Dr Asokan Naidoo /ID# 252894
Umhlanga, KwaZulu-Natal, South Africa
Winelands Medical Research - Somerset West /ID# 252745
Cape Town, Western Cape, South Africa
Arthritis Clinical Research Trials /ID# 252370
Cape Town, Western Cape, South Africa
Winelands Medical Research Centre /ID# 252369
Stellenbosch, Western Cape, South Africa
SoonChunHyang University Hospital Cheonan /ID# 254942
Cheonan-si, Chungcheongnam-do, South Korea
Chungnam National University Hospital /ID# 252159
Daejeon, Daejeon Gwang Yeogsi, South Korea
Chonnam National University Bitgoeul Hospital /ID# 254802
Gwangju, Gwangju Gwang Yeogsi, South Korea
Seoul National University Hospital /ID# 252160
Seoul, Seoul Teugbyeolsi, South Korea
Hanyang University Seoul Hospital /ID# 252161
Seoul, Seoul Teugbyeolsi, South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 252430
Santiago de Compostela, A Coruna, Spain
Hospital Marina Baixa /ID# 254141
Villajoyosa, Alicante, Spain
Hospital Universitario Germans Trias i Pujol /ID# 254144
Badalona, Barcelona, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425
Sabadell, Barcelona, Spain
Hospital Universitario y Politecnico La Fe /ID# 254143
Valencia, Spain
Royal Free Hospital /ID# 252297
London, Greater London, United Kingdom
The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301
Kings Lynn, Norfolk, United Kingdom
Queen Mary University of London /ID# 252671
London, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 252772
Portsmouth, United Kingdom