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)

April 19, 2024 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

Recruiting

Conditions

Rheumatoid Arthritis

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

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 Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Belgium
- - Genk, Belgium, 3600
    - Recruiting
    - ReumaClinic /ID# 252277
  - Liege, Belgium, 4000
    - Recruiting
    - CHU de Liege /ID# 252309
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 252306
Brazil
- - Sao Paulo, Brazil, 04266-010
    - Recruiting
    - CEPIC - Centro Paulista de Investigacao Clinica /ID# 254200
- Parana
  - Curitiba, Parana, Brazil, 80030-110
    - Recruiting
    - CETI - Centro de Estudos em Terapias Inovadoras /ID# 254201
Bulgaria
- - Plovdiv, Bulgaria, 4027
    - Recruiting
    - MHAT Plovdiv /ID# 252342
  - Plovdiv, Bulgaria, 4001
    - Recruiting
    - UMHAT Kaspela EOOD /ID# 252343
  - Plovdiv, Bulgaria, 4023
    - Recruiting
    - Medical center Unimed /ID# 252344
  - Sofia, Bulgaria, 1505
    - Recruiting
    - Diagnostic consultative center 17 Sofia /ID# 252341
  - Sofia, Bulgaria, 1606
    - Recruiting
    - Military Medical Academy Multiprofile Hospital /ID# 252355
  - Sofiya, Bulgaria, 1463
    - Recruiting
    - Diagnostic consultative center Focus-5 /ID# 252354
  - Sofiya, Bulgaria, 1463
    - Recruiting
    - Diagnostic consultative center Focus-5 /ID# 252555
Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1M3
    - Recruiting
    - Manitoba Clinic /ID# 254019
- Quebec
  - Rimouski, Quebec, Canada, G5L 8W1
    - Recruiting
    - Centre Rhumatologie de l'Est /ID# 254932
  - Sainte-foy, Quebec, Canada, G1V 3M7
    - Recruiting
    - Groupe de Recherche en Maladies Osseuses Inc /ID# 253409
  - Trois-rivières, Quebec, Canada, G8Z 1Y2
    - Recruiting
    - Centre de Recherche Musculo-Squelettique /ID# 256273
    - Contact:
      
      Site Coordinator
      
      Phone Number: 819-370-1301
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7H 5M7
    - Recruiting
    - Dr Naik-Medical Professional Corporation-Alliance Health /ID# 254018
Chile
- - Santiago, Chile, 7640881
    - Recruiting
    - Clinica Dermacross /ID# 252560
  - Santiago, Chile, 8420383
    - Recruiting
    - Centro Internacional de Estudios Clinicos - CIEC /ID# 252561
- Los Lagos
  - Osorno, Los Lagos, Chile, 1710216
    - Recruiting
    - Corporacion de Beneficiencia Osorno /ID# 252556
- Region Metropolitana De Santiago
  - Santiago, Region Metropolitana De Santiago, Chile, 8207257
    - Recruiting
    - Complejo Asistencial Dr. Sotero del Rio /ID# 252559
China
- Beijing
  - Beijing, Beijing, China, 100034
    - Recruiting
    - Peking University First Hospital /ID# 252392
- Guangdong
  - Guangzhou, Guangdong, China, 510630
    - Recruiting
    - The Third Affiliated Hospital, Sun Yat-Sen University /ID# 252394
- Hunan
  - Zhuzhou, Hunan, China, 412007
    - Recruiting
    - Zhuzhou Central Hospital /ID# 252390
- Jiangxi
  - Pingxiang, Jiangxi, China, 337055
    - Recruiting
    - Jiangxi Pingxiang People's Hospital /ID# 252381
Croatia
- - Grad Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Solmed /ID# 252453
  - Krapinske Toplice, Croatia, 49217
    - Recruiting
    - Specijalna bolnica za medicinsku rehabilitaciju Krapinske Toplice /ID# 252455
  - Zagreb, Croatia, 10000
    - Recruiting
    - Medical Center Kuna-Peric /ID# 252452
  - Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Bonifarm /ID# 252741
- Grad Zagreb
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Poliklinika Repromed /ID# 252451
France
- - Orléans, France, 45067
    - Recruiting
    - Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 252385
  - Rouen, France, 76000
    - Recruiting
    - Hôpital Charles-Nicolle /ID# 252908
- Haute-Garonne
  - TOULOUSE Cedex 9, Haute-Garonne, France, 31059
    - Recruiting
    - CHU Toulouse - Hopital Purpan /ID# 252402
- Herault
  - Montpellier, Herault, France, 34090
    - Recruiting
    - CHU Montpellier - Hôpital Lapeyronie /ID# 252386
- Provence-Alpes-Cote-d Azur
  - Nice CEDEX 1, Provence-Alpes-Cote-d Azur, France, 06002
    - Recruiting
    - CHU Nice -Hopital Pasteur /ID# 254224
- Somme
  - Amiens CEDEX 1, Somme, France, 80054
    - Recruiting
    - CHU Amiens-Picardie Site Sud /ID# 252384
Germany
- - Herne, Germany, 44649
    - Recruiting
    - Rheumazentrum Ruhrgebiet /ID# 252670
  - Planegg, Germany, 82152
    - Recruiting
    - Klinische Forschung im med. Versorgungsalltag GbR /ID# 254221
  - Ratingen, Germany, 40882
    - Recruiting
    - Rheumazentrum Ratingen /ID# 252669
- Brandenburg
  - Templin, Brandenburg, Germany, 17268
    - Recruiting
    - Rheumatologische-Immunologische Praxis Templin /ID# 252863
Greece
- Attiki
  - Athens, Attiki, Greece, 12462
    - Recruiting
    - University General Hospital Attikon /ID# 254751
  - Athens, Attiki, Greece, 11527
    - Recruiting
    - General Hospital of Athens Laiko /ID# 252258
- Kriti
  - Heraklion, Kriti, Greece, 71500
    - Recruiting
    - University General Hospital of Heraklion PA.G.N.I /ID# 252261
    - Contact:
      
      Site Coordinator
      
      Phone Number: +30-281-039-2024
Hungary
- - Budapest, Hungary, 1023
    - Recruiting
    - Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 253311
  - Szekesfehervar, Hungary, 8000
    - Recruiting
    - CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 252400
  - Szolnok, Hungary, 5000
    - Recruiting
    - MÁV Kórház /ID# 252628
- Veszprem
  - Veszprém, Veszprem, Hungary, 8200
    - Recruiting
    - Vital Medicina Kft /ID# 252399
Italy
- - Milan, Italy, 20122
    - Recruiting
    - ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 252461
- Ancona
  - Torette, Ancona, Italy, 60020
    - Recruiting
    - Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 252459
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 457-8511
    - Recruiting
    - Daido Clinic /ID# 253058
  - Nagoya-shi, Aichi, Japan, 455-8530
    - Recruiting
    - Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836
- Fukui
  - Fukui-shi, Fukui, Japan, 910-0068
    - Recruiting
    - Sugimoto Rheumatology and Internal Medicine Clinic /ID# 252774
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 814-0002
    - Recruiting
    - Shono Rheumatism Clinic /ID# 252591
  - Fukuoka-shi, Fukuoka, Japan, 810-8539
    - Recruiting
    - Hamanomachi Hospital /ID# 253168
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 078-8243
    - Recruiting
    - Katayama Orthopedic Rheumatology Clinic /ID# 252746
  - Sapporo-shi, Hokkaido, Japan, 060-0001
    - Recruiting
    - Sagawa Akira Rheumatology Clin /ID# 252773
- Hyogo
  - Kato-shi, Hyogo, Japan, 673-1462
    - Recruiting
    - Matsubara Mayflower Hospital /ID# 252834
- Kagawa
  - Sanuki-shi, Kagawa, Japan, 769-2393
    - Recruiting
    - Sanuki Municipal Hospital /ID# 252747
- Kochi
  - Kochi-shi, Kochi, Japan, 781-0112
    - Recruiting
    - Bay Side Misato Medical Center /ID# 252661
- Kumamoto
  - Kumamoto shi, Kumamoto, Japan, 8620975
    - Recruiting
    - Kumamoto Orthopaedic Hospital /ID# 253167
- Miyazaki
  - Miyazaki-shi, Miyazaki, Japan, 880-0053
    - Recruiting
    - Medical Corporation Keiai Kai Clinic /ID# 252750
- Nagasaki
  - Sasebo-shi, Nagasaki, Japan, 857-1195
    - Recruiting
    - Sasebo Chuo Hospital /ID# 252662
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-8560
    - Recruiting
    - St.Luke's International Hospital /ID# 253131
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Recruiting
    - Keio University Hospital /ID# 253205
- Yamaguchi
  - Shimonoseki-shi, Yamaguchi, Japan, 752-0976
    - Recruiting
    - Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057
Korea, Republic of
- - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 252160
- Chungcheongnamdo
  - Cheonan-si, Chungcheongnamdo, Korea, Republic of, 31151
    - Recruiting
    - SoonChunHyang University Hospital Cheonan /ID# 254942
- Daejeon Gwang Yeogsi
  - Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of, 35015
    - Recruiting
    - Chungnam National University Hospital /ID# 252159
- Gwangju Gwang Yeogsi
  - Gwangju, Gwangju Gwang Yeogsi, Korea, Republic of, 61748
    - Recruiting
    - Chonnam National University Bitgoeul Hospital /ID# 254802
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
    - Recruiting
    - Hanyang University Seoul Hospital /ID# 252161
Portugal
- - Almada, Portugal, 2805-267
    - Recruiting
    - Hospital Garcia de Orta, EPE /ID# 252491
  - Lisboa, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 252492
- Viana Do Castelo
  - Ponte de Lima, Viana Do Castelo, Portugal, 4990-041
    - Recruiting
    - Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 252489
Puerto Rico
- - San Juan, Puerto Rico, 00918-3756
    - Recruiting
    - Mindful Medical Research /ID# 252693
  - San Juan, Puerto Rico, 00917-3104
    - Recruiting
    - GCM Medical Group PSC /ID# 252700
Romania
- - Bacau, Romania, 600114
    - Recruiting
    - Spitalul Judetean de Urgenta Bacau /ID# 252860
  - Bucuresti, Romania, 011172
    - Recruiting
    - Spitalul Clinic Sf. Maria /ID# 252759
  - Bucuresti, Romania, 011172
    - Recruiting
    - Spitalul Clinic Sf. Maria /ID# 253334
- Timis
  - Timisoara, Timis, Romania, 300134
    - Recruiting
    - Cabinet Medical Dr. Avram S.R.L /ID# 254133
  - Timisoara, Timis, Romania, 300766
    - Recruiting
    - Banat Carina Med SRL /ID# 252757
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Institute for Rheumatology /ID# 252334
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Institute for Rheumatology /ID# 252335
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Institute for Rheumatology /ID# 252338
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - Institute for Rheumatology /ID# 252333
- Vojvodina
  - Novi Sad, Vojvodina, Serbia, 21000
    - Recruiting
    - Special Hospital for Rheuma /ID# 252336
  - Novi Sad, Vojvodina, Serbia, 21000
    - Recruiting
    - Special Hospital for Rheuma /ID# 252339
South Africa
- Gauteng
  - Pretoria, Gauteng, South Africa, 0001
    - Recruiting
    - University of Pretoria /ID# 252368
  - Pretoria, Gauteng, South Africa, 0002
    - Recruiting
    - Dr Elsa van Duuren /ID# 252387
  - Pretoria, Gauteng, South Africa, 0002
    - Recruiting
    - Emmed Research cc /ID# 254317
- Kwazulu-Natal
  - Umhlanga, Kwazulu-Natal, South Africa, 4319
    - Recruiting
    - Dr Asokan Naidoo /ID# 252894
- Western Cape
  - Cape Town, Western Cape, South Africa, 7405
    - Recruiting
    - Arthritis Clinical Research Trials /ID# 252370
  - Cape Town, Western Cape, South Africa, 7130
    - Recruiting
    - Winelands Medical Research - Somerset West /ID# 252745
  - Stellenbosch, Western Cape, South Africa, 7600
    - Recruiting
    - Winelands Medical Research Centre /ID# 252369
Spain
- - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitario y Politecnico La Fe /ID# 254143
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Recruiting
    - Hospital Clínico Universitario de Santiago-CHUS /ID# 252430
- Alicante
  - Villajoyosa, Alicante, Spain, 03570
    - Recruiting
    - Hospital Marina Baixa /ID# 254141
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Recruiting
    - Hospital Universitario Germans Trias i Pujol /ID# 254144
  - Sabadell, Barcelona, Spain, 08208
    - Recruiting
    - Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 252425
United Kingdom
- - London, United Kingdom, EC1M 6BQ
    - Recruiting
    - Queen Mary University of London /ID# 252671
  - Portsmouth, United Kingdom, PO6 3LY
    - Recruiting
    - Portsmouth Hospitals University NHS Trust /ID# 252772
- London, City Of
  - London, London, City Of, United Kingdom, NW3 2QG
    - Recruiting
    - The Royal Free London NHS Foundation Trust /ID# 252297
- Norfolk
  - Kings Lynn, Norfolk, United Kingdom, PE30 4ET
    - Recruiting
    - The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301
United States
- Arizona
  - Flagstaff, Arizona, United States, 86001-6299
    - Recruiting
    - AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431
  - Glendale, Arizona, United States, 85306-9802
    - Recruiting
    - Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
  - Peoria, Arizona, United States, 85381
    - Recruiting
    - Sun Valley Arthritis Center Ltd. /ID# 254654
  - Phoenix, Arizona, United States, 85032-9306
    - Recruiting
    - AZ Arthritis and Rheumotology Research, PLLC /ID# 255021
  - Phoenix, Arizona, United States, 85032-9306
    - Recruiting
    - AZ Arthritis and Rheumotology Research, PLLC /ID# 253432
  - Tucson, Arizona, United States, 85704
    - Recruiting
    - Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
- Arkansas
  - Jonesboro, Arkansas, United States, 72401-6251
    - Recruiting
    - Arthritis and Rheumatism Associates /ID# 254013
    - Contact:
      
      Site Coordinator
      
      Phone Number: 870-333-2721
- California
  - Fullerton, California, United States, 92835
    - Recruiting
    - Providence - St. Jude Medical Center /ID# 252690
  - Huntington Beach, California, United States, 92648-5994
    - Recruiting
    - Newport Huntington Medical Group /ID# 252687
  - La Mesa, California, United States, 91942
    - Recruiting
    - Purushotham & Akther Kotha MD, Inc /ID# 252704
    - Contact:
      
      Site Coordinator
      
      Phone Number: (619) 229-1995 x 208
  - Los Alamitos, California, United States, 90720-5402
    - Recruiting
    - Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692
  - San Diego, California, United States, 92128-2549
    - Recruiting
    - Rheumatology Center of San Diego /ID# 255038
  - Thousand Oaks, California, United States, 91360-3951
    - Recruiting
    - Millennium Clinical Trials /ID# 252689
  - Torrance, California, United States, 90502
    - Recruiting
    - The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691
  - Woodland Hills, California, United States, 91364
    - Recruiting
    - Comprehensive Rheumatology Center /ID# 252688
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Hospital /ID# 254617
  - Denver, Colorado, United States, 80230
    - Recruiting
    - Denver Arthritis Clinic /ID# 254058
  - Fort Collins, Colorado, United States, 80528
    - Recruiting
    - Tekton Research /ID# 255036
- Florida
  - Aventura, Florida, United States, 33180
    - Recruiting
    - Arthritis & Rheumatic Disease Specialties /ID# 260583
  - Boca Raton, Florida, United States, 33486
    - Recruiting
    - Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733
  - Brandon, Florida, United States, 33511
    - Recruiting
    - Bay Area Arthritis and Osteo /ID# 254046
    - Contact:
      
      Site Coordinator
      
      Phone Number: 813-651-4441
  - Coral Springs, Florida, United States, 33065
    - Recruiting
    - Believe Clinical Trials /ID# 262355
  - Daytona Beach, Florida, United States, 32117
    - Recruiting
    - International Medical Research /ID# 254651
  - DeBary, Florida, United States, 32713-2260
    - Recruiting
    - Omega Research Debary, LLC /ID# 253735
  - Hialeah, Florida, United States, 33016-1897
    - Recruiting
    - Neoclinical Research /ID# 254622
    - Contact:
      
      Site Coordinator
      
      Phone Number: 305-456-9062
  - Margate, Florida, United States, 33063
    - Recruiting
    - Life Clinical Trials - Margate - FL-7 /ID# 256061
  - Miami, Florida, United States, 33014
    - Completed
    - Lakes Research, LLC /ID# 255023
  - Orlando, Florida, United States, 32819
    - Recruiting
    - HMD Research LLC /ID# 253732
  - Ormond Beach, Florida, United States, 32174
    - Recruiting
    - Millennium Research /ID# 253744
  - Saint Petersburg, Florida, United States, 33705
    - Recruiting
    - BayCare Medical Group /ID# 253799
  - Tampa, Florida, United States, 33606-1246
    - Recruiting
    - Clinical Research of West Florida - Tampa /ID# 255264
  - Tampa, Florida, United States, 33614-7101
    - Recruiting
    - BayCare Medical Group, Inc. /ID# 255268
    - Contact:
      
      Site Coordinator
      
      Phone Number: 813-840-3600
  - Tampa, Florida, United States, 33606-1246
    - Recruiting
    - Clinical Research of West Florida, Inc /ID# 254649
- Georgia
  - Marietta, Georgia, United States, 20060
    - Recruiting
    - Atlanta Research Center for Rheumatology /ID# 254623
- Illinois
  - Hinsdale, Illinois, United States, 60521-3186
    - Recruiting
    - Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 254712
  - Libertyville, Illinois, United States, 60048
    - Recruiting
    - Deerbrook Medical Associates /ID# 254008
    - Contact:
      
      Site Coordinator
      
      Phone Number: 1-867-367-7340
  - Rockford, Illinois, United States, 61114-4937
    - Recruiting
    - OrthoIllinois /ID# 254057
  - Schaumburg, Illinois, United States, 60195-3106
    - Recruiting
    - Greater Chicago Specialty Physicians /ID# 254000
  - Skokie, Illinois, United States, 60076
    - Recruiting
    - Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 253999
- Indiana
  - Evansville, Indiana, United States, 47715-2813
    - Recruiting
    - Qualmedica Research - Evansville /ID# 254005
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - Completed
    - Bluegrass Community Research /ID# 254653
- Louisiana
  - Baton Rouge, Louisiana, United States, 70836-6455
    - Recruiting
    - Ochsner Clinic Foundation /ID# 254059
  - Monroe, Louisiana, United States, 71203
    - Recruiting
    - The Arthritis & Diabetes Clinic, Inc. /ID# 254014
- Maine
  - Portland, Maine, United States, 04102-2643
    - Recruiting
    - Rheumatology Associates PA - Portland /ID# 255014
- Massachusetts
  - Boston, Massachusetts, United States, 02149-4903
    - Recruiting
    - Beth Israel Deaconess Medical Center - Rheumatology /ID# 255029
- Michigan
  - Grand Blanc, Michigan, United States, 48439
    - Recruiting
    - AA Medical Research Center - Grand Blanc /ID# 254007
    - Contact:
      
      Site Coordinator
      
      Phone Number: 810-694-0082
  - Lansing, Michigan, United States, 48910
    - Recruiting
    - Advanced Rheumatology, PC /ID# 256059
- Minnesota
  - Eagan, Minnesota, United States, 55121
    - Recruiting
    - St. Paul Rheumatology, PA /ID# 255037
- Mississippi
  - Hattiesburg, Mississippi, United States, 39402
    - Recruiting
    - Arthritis Associates /ID# 253992
- Missouri
  - Kansas City, Missouri, United States, 64151
    - Recruiting
    - Kansas City Physician Partners /ID# 255035
  - Springfield, Missouri, United States, 65807
    - Recruiting
    - Clinvest Research LLC /ID# 254054
- Montana
  - Kalispell, Montana, United States, 59901
    - Recruiting
    - Logan Health Research /ID# 253738
- Nebraska
  - Lincoln, Nebraska, United States, 68516
    - Recruiting
    - Physician Research Collaboration, LLC /ID# 254012
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Recruiting
    - Dartmouth-Hitchcock Medical Center /ID# 253798
- New Jersey
  - Voorhees, New Jersey, United States, 08043
    - Recruiting
    - Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 255266
- New Mexico
  - Las Cruces, New Mexico, United States, 88011
    - Recruiting
    - Arthritis and Osteo Assoc /ID# 252684
- New York
  - Brooklyn, New York, United States, 11201
    - Recruiting
    - NYU Langone Ambulatory Care Brooklyn Heights /ID# 254621
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Recruiting
    - Trinity Health Med Arts Clinic /ID# 254010
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Recruiting
    - Paramount Medical Research Con /ID# 254048
    - Contact:
      
      Site Coordinator
      
      Phone Number: 440-826-0742
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73116-7226
    - Recruiting
    - Rheumatology Associates of Oklahoma /ID# 253994
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Clinical Research of Philadelphia, LLC /ID# 255025
    - Contact:
      
      Site Coordinator
      
      Phone Number: 212-676-6696
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - Recruiting
    - West Tennessee Research Institute /ID# 254620
- Texas
  - Allen, Texas, United States, 75013-6147
    - Recruiting
    - Arthritis and Rheumatology Research Institute, PLLC /ID# 254045
    - Contact:
      
      Site Coordinator
      
      Phone Number: (972) 798-8553
  - Austin, Texas, United States, 78745
    - Recruiting
    - Tekton Research, Inc. /ID# 254004
    - Contact:
      
      Site Coordinator
      
      Phone Number: 512-388-5717
  - Carrollton, Texas, United States, 75007
    - Recruiting
    - Trinity Universal Research Associates - Carrollton /ID# 254648
  - Fort Worth, Texas, United States, 76104-4917
    - Recruiting
    - JPS Rheumatology Clinic /ID# 254050
  - Houston, Texas, United States, 77089
    - Recruiting
    - Accurate Clinical Research /ID# 254647
  - Houston, Texas, United States, 77043
    - Recruiting
    - Biopharma Informatic - Houston - Business Center Drive /ID# 254051
  - Houston, Texas, United States, 77043
    - Recruiting
    - Biopharma Informatic - Houston - Business Center Drive /ID# 254053
  - Katy, Texas, United States, 77450-2244
    - Recruiting
    - R & H Clinical Research - 777 Katy /ID# 255024
  - Lubbock, Texas, United States, 79424
    - Recruiting
    - West Texas Clinical Research /ID# 253736
    - Contact:
      
      Site Coordinator
      
      Phone Number: 8069931040
  - Plano, Texas, United States, 75024-5283
    - Recruiting
    - Trinity Universal Research Associates, Inc /ID# 253995
  - San Antonio, Texas, United States, 78215
    - Recruiting
    - Sun Research Institute /ID# 255019
  - The Woodlands, Texas, United States, 77382
    - Recruiting
    - Advanced Rheumatology of Houston /ID# 254003
    - Contact:
      
      Site Coordinator
      
      Phone Number: 281-766-7886
  - Tomball, Texas, United States, 77377
    - Recruiting
    - Rheumatology Clinic of Houston /ID# 254002
    - Contact:
      
      Site Coordinator
      
      Phone Number: 2815170550
  - Tomball, Texas, United States, 77375
    - Recruiting
    - DM Clinical Research - Tomball /ID# 254001
    - Contact:
      
      Site Coordinator
      
      Phone Number: 2815170550
- Wisconsin
  - Franklin, Wisconsin, United States, 53132
    - Recruiting
    - Aurora Rheumatology and Immunotherapy Center /ID# 254049
  - Glendale, Wisconsin, United States, 53217
    - Recruiting
    - 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

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)

September 23, 2025

Study Completion (Estimated)

August 15, 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 (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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
CSR

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 (Estimated)

Phase

Contacts and Locations

Study Contact

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 (Actual)

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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