A Study to Compare the Response to Treatment With Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive, and Shared Epitope-positive Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Last updated: February 18, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

Adalimumab

Abatacept

Methotrexate

Clinical Study ID

NCT04909801
IM101-863
2020-000350-96
U1111-1247-1367
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the superiority in efficacy of abatacept compared with adalimumab, on background methotrexate, in adults with early, seropositive, and shared epitope-positive rheumatoid arthritis and an inadequate methotrexate response.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 monthsprior to screening and satisfied the American College of Rheumatology/EuropeanLeague Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA atsome point during the 12-month period

  • Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumaticdrugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), orinvestigational therapies for RA

  • Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTXfor at least 4 weeks prior to randomization

  • Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limitof normal and are positive for rheumatoid factor (RF) according to central labtesting during screening

  • At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening

  • At least 3 tender and at least 3 swollen joints at screening and at randomization

Exclusion

Exclusion Criteria:

  • Women who are breastfeeding

  • Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease,Sjogren's syndrome) or currently active fibromyalgia

  • History of or current inflammatory joint disease other than RA (e.g., psoriaticarthritis, gout, reactive arthritis, Lyme disease)

  • At risk for tuberculosis

  • Recent acute infection

  • History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,osteomyelitis, bronchiectasis)

  • History of infection of a joint prosthesis or artificial joint

  • History of systemic fungal infections (such as histoplasmosis, blastomycosis, orcoccidiomycosis)

  • History of primary immunodeficiency

  • Current clinical findings or a history of a demyelinating disorder

  • 5 or more joints cannot be assessed for tenderness or swelling

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 338
Treatment Group(s): 3
Primary Treatment: Adalimumab
Phase: 3
Study Start date:
September 15, 2021
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Local Institution

    C.a.b.a., Buenos Aires 1431
    Argentina

    Site Not Available

  • Local Institution - 0012

    Caba, Buenos Aires C1015ABO
    Argentina

    Site Not Available

  • Local Institution - 0024

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Local Institution - 0016

    Quilmes, Buenos Aires 1878
    Argentina

    Site Not Available

  • Local Institution - 0014

    San Isidro, Buenos Aires 1642
    Argentina

    Site Not Available

  • Local Institution

    DQG, Distrito Federal C1428
    Argentina

    Site Not Available

  • Local Institution - 0057

    San Miguel de Tucumán, Tucuman T4000
    Argentina

    Site Not Available

  • Local Institution - 0015

    Buenos Aires, 1431
    Argentina

    Site Not Available

  • Local Institution - 0022

    Buenos Aires, 1428
    Argentina

    Site Not Available

  • Local Institution - 0023

    Buenos Aires, 1428
    Argentina

    Site Not Available

  • Local Institution - 0099

    Cordoba, 0
    Argentina

    Site Not Available

  • Local Institution - 0072

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Local Institution

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Local Institution - 0062

    Paramatta, New South Wales 2150
    Australia

    Site Not Available

  • Local Institution

    Parramatta, New South Wales 2150
    Australia

    Site Not Available

  • Local Institution - 0063

    Maroochydore, Queensland 4558
    Australia

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  • Local Institution - 0102

    Woodville South, South Australia 5011
    Australia

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  • Local Institution - 0064

    Camberwell, Victoria 3124
    Australia

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  • Local Institution - 0065

    Geelong, Victoria 3220
    Australia

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  • Local Institution - 0105

    Ivanhoe, Victoria 3079
    Australia

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  • Local Institution - 0028

    Brno, 638 00
    Czechia

    Site Not Available

  • Revmatologicky ustav

    Praha, 12800
    Czechia

    Site Not Available

  • Local Institution - 0025

    Praha 2, 12850
    Czechia

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  • Local Institution - 0001

    Montpellier, 34295
    France

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  • Local Institution - 0047

    Rouen, 76031
    France

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  • Local Institution - 0035

    Strasbourg, 67098
    France

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  • Local Institution - 0002

    Toulouse, 31059
    France

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  • Local Institution - 0059

    Berlin, 10117
    Germany

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  • Local Institution - 0055

    Bonn, 53127
    Germany

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  • Local Institution - 0091

    Freiburg, 79106
    Germany

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  • Local Institution

    Freiburg im Breisgau, 79106
    Germany

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  • Local Institution - 0053

    Hamburg, 20095
    Germany

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  • Local Institution - 0056

    Planegg, 82152
    Germany

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  • Local Institution - 0083

    Catania, 95121
    Italy

    Site Not Available

  • POLICLINICO "G. RODOLICO"-Rheumatology

    Catania, 95121
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Local Institution - 0077

    Pavia, 27100
    Italy

    Site Not Available

  • Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and

    Perugia, 06156
    Italy

    Site Not Available

  • Local Institution - 0078

    Perugia, 06156
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Local Institution - 0100

    Roma, 00168
    Italy

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  • Local Institution

    Rome, 00168
    Italy

    Site Not Available

  • Local Institution - 0093

    Nagoya, Aichi 457-8511
    Japan

    Site Not Available

  • Local Institution - 0079

    Kitakyushu, Fukuoka 807-8556
    Japan

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  • Local Institution

    Kitakyushu-shi, Fukuoka 8078556
    Japan

    Site Not Available

  • Local Institution - 0110

    Sapporo, Hokkaido 0608648
    Japan

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  • Local Institution

    Sendai, Miyagi 9808574
    Japan

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  • Local Institution - 0046

    Sendai-shi, Miyagi 980-8574
    Japan

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  • Local Institution - 0112

    Sasebo, Nagasaki 857-1195
    Japan

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  • Local Institution

    Kawagoe, Saitama 3508550
    Japan

    Site Not Available

  • Local Institution - 0090

    Kawagoe, Saitama 350-8550
    Japan

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  • Local Institution - 0090

    Kawagoe-shi, Saitama 3508550
    Japan

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  • Local Institution - 0089

    Chuo-ku, Tokyo 1048560
    Japan

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  • Local Institution

    Shinjuku-ku, Tokyo 1600016
    Japan

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  • Local Institution - 0093

    Aichi, 457-8511
    Japan

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  • Local Institution - 0010

    Tokyo, 1600035
    Japan

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  • Local Institution - 0089

    Tokyo, 104-8560
    Japan

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  • Local Institution - 0006

    Cdmx, Distrito Federal 11850
    Mexico

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  • Local Institution

    Mexico, Distrito Federal 11850
    Mexico

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  • Local Institution - 0008

    Mexico City, Distrito Federal 14080
    Mexico

    Site Not Available

  • Local Institution - 0017

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Local Institution - 0117

    Guadalajara, Jalisco 44650
    Mexico

    Site Not Available

  • Local Institution - 0118

    San Luis Potosí, SAN LUIS Potosi 78200
    Mexico

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  • Local Institution

    Merida, Yucatan 97070
    Mexico

    Site Not Available

  • Local Institution - 0005

    Mérida, Yucatán 97070
    Mexico

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  • Local Institution - 0009

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Local Institution

    San Luis Potosi, 78200
    Mexico

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  • Local Institution - 0020

    Torun, Kujawsko-pomorskie 87-100
    Poland

    Site Not Available

  • Local Institution

    Bydgoszcz, 85-168
    Poland

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  • Local Institution - 0124

    Bydgoszcz, 85-168
    Poland

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  • Local Institution - 0019

    Elblag, 82-300
    Poland

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  • Local Institution

    A Coruna, 15006
    Spain

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  • Local Institution - 0004

    A Coruña, 15006
    Spain

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  • Local Institution - 0003

    Madrid, 28046
    Spain

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  • Local Institution - 0085

    Santander, 39008
    Spain

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  • Local Institution - 0049

    Basel, 4031
    Switzerland

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  • Local Institution - 0052

    St. Gallen, 9007
    Switzerland

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  • Local Institution

    Kaohsiung, 803
    Taiwan

    Site Not Available

  • Local Institution - 0098

    Kaohsiung Niao Sung Dist, 83301
    Taiwan

    Site Not Available

  • Local Institution - 0104

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Local Institution - 0096

    Taichung, 40447
    Taiwan

    Site Not Available

  • Local Institution - 0095

    Taichung City, 402
    Taiwan

    Site Not Available

  • Local Institution - 0120

    Tainan, 704
    Taiwan

    Site Not Available

  • Local Institution - 0111

    Cannock, Staffordshire WS11 5XY
    United Kingdom

    Site Not Available

  • Local Institution

    Greater London, London, SE1 1UL
    United Kingdom

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  • Local Institution - 0060

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Local Institution - 0114

    London, SE1 9RT
    United Kingdom

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  • Local Institution

    Wolverhampton, WV10 0QP
    United Kingdom

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  • Local Institution - 0036

    Fullerton, California 92835
    United States

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  • Local Institution - 0086

    Los Alamitos, California 90720
    United States

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  • Local Institution - 0041

    Aurora, Colorado 80045
    United States

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  • Local Institution - 0058

    Cumberland, Maryland 21502
    United States

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  • Local Institution - 0038

    Hagerstown, Maryland 21740
    United States

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  • Local Institution - 0084

    Eagan, Minnesota 55121
    United States

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  • Local Institution

    Saint Louis, Missouri 63141
    United States

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  • Local Institution

    Lincoln, Nebraska 68516
    United States

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  • Local Institution - 0040

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • NYU Langone Ambulatory Care Brooklyn Heights

    Brooklyn, New York 11201
    United States

    Site Not Available

  • Local Institution - 0082

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Local Institution - 0127

    Portland, Oregon 97239
    United States

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  • Local Institution - 0031

    Duncansville, Pennsylvania 16635
    United States

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  • Local Institution - 0034

    Jackson, Tennessee 38305
    United States

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  • Local Institution - 0044

    Dallas, Texas 75231
    United States

    Site Not Available

  • Local Institution

    Glendale, Wisconsin 53217
    United States

    Site Not Available

  • Local Institution - 0119

    Milwaukee, Wisconsin 53217
    United States

    Site Not Available

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