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
NCT ID: NCT04909801
Last Updated: 2025-02-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
338 participants
INTERVENTIONAL
2021-09-15
2027-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Abatacept Versus Adalimumab Head-to-Head
NCT00929864
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
NCT00048568
Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis
NCT02557100
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy
NCT00124982
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
NCT02504268
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1: Abatacept + Methotrexate
Abatacept
Abatacept SC (125 mg) once weekly
Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Abatacept
Abatacept SC (125 mg) once weekly
Adalimumab
Adalimumab SC (40 mg) once every 2 weeks
Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abatacept
Abatacept SC (125 mg) once weekly
Adalimumab
Adalimumab SC (40 mg) once every 2 weeks
Methotrexate
Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA
* Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization
* Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is \> 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing 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 Criteria
* 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., psoriatic arthritis, 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, or coccidiomycosis)
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0036
Fullerton, California, United States
Local Institution - 0086
Los Alamitos, California, United States
Local Institution - 0041
Aurora, Colorado, United States
Local Institution - 0058
Cumberland, Maryland, United States
Local Institution - 0038
Hagerstown, Maryland, United States
Local Institution - 0084
Eagan, Minnesota, United States
Local Institution - 0040
Freehold, New Jersey, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
Local Institution - 0082
Wilmington, North Carolina, United States
Local Institution - 0127
Portland, Oregon, United States
Local Institution - 0031
Duncansville, Pennsylvania, United States
Local Institution - 0034
Jackson, Tennessee, United States
Local Institution - 0044
Dallas, Texas, United States
Local Institution - 0119
Milwaukee, Wisconsin, United States
Local Institution - 0012
CABA, Buenos Aires, Argentina
Local Institution - 0016
Quilmes, Buenos Aires, Argentina
Local Institution - 0014
San Isidro, Buenos Aires, Argentina
Local Institution - 0057
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0022
Buenos Aires, , Argentina
Local Institution - 0023
Buenos Aires, , Argentina
Local Institution - 0015
Buenos Aires, , Argentina
Local Institution - 0099
Córdoba, , Argentina
Local Institution - 0072
Botany, New South Wales, Australia
Local Institution - 0062
Paramatta, New South Wales, Australia
Local Institution - 0063
Maroochydore, Queensland, Australia
Local Institution - 0102
Woodville South, South Australia, Australia
Local Institution - 0064
Camberwell, Victoria, Australia
Local Institution - 0065
Geelong, Victoria, Australia
Local Institution - 0105
Ivanhoe, Victoria, Australia
Local Institution - 0028
Brno, , Czechia
Local Institution - 0025
Prague, , Czechia
Local Institution - 0001
Montpellier, , France
Local Institution - 0047
Rouen, , France
Local Institution - 0035
Strasbourg, , France
Local Institution - 0002
Toulouse, , France
Local Institution - 0059
Berlin, , Germany
Local Institution - 0055
Bonn, , Germany
Local Institution - 0091
Freiburg im Breisgau, , Germany
Local Institution - 0053
Hamburg, , Germany
Local Institution - 0056
Planegg, , Germany
Local Institution - 0083
Catania, , Italy
Local Institution - 0077
Pavia, , Italy
Local Institution - 0078
Perugia, , Italy
Local Institution - 0100
Roma, , Italy
Local Institution - 0093
Nagoya, Aichi-ken, Japan
Local Institution - 0079
Kitakyushu, Fukuoka, Japan
Local Institution - 0110
Sapporo, Hokkaido, Japan
Local Institution - 0046
Sendai, Miyagi, Japan
Local Institution - 0112
Sasebo, Nagasaki, Japan
Local Institution - 0090
Kawagoe, Saitama, Japan
Local Institution - 0089
Tokyo, , Japan
Local Institution - 0010
Tokyo, , Japan
Local Institution - 0017
Guadalajara, Jalisco, Mexico
Local Institution - 0117
Guadalajara, Jalisco, Mexico
Local Institution - 0006
Mexico City, Mexico City, Mexico
Local Institution - 0008
Mexico City, Mexico City, Mexico
Local Institution - 0118
San Luis Potosí City, San Luis Potosí, Mexico
Local Institution - 0005
Mérida, Yucatán, Mexico
Local Institution - 0009
Chihuahua City, , Mexico
Local Institution - 0020
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0124
Bydgoszcz, , Poland
Local Institution - 0019
Elblag, , Poland
Local Institution - 0004
A Coruña, , Spain
Local Institution - 0003
Madrid, , Spain
Local Institution - 0085
Santander, , Spain
Local Institution - 0049
Basel, , Switzerland
Local Institution - 0052
Sankt Gallen, , Switzerland
Local Institution - 0098
Kaohsiung Niao Sung Dist, , Taiwan
Local Institution - 0104
New Taipei City, , Taiwan
Local Institution - 0095
Taichung, , Taiwan
Local Institution - 0096
Taichung, , Taiwan
Local Institution - 0120
Tainan City, , Taiwan
Local Institution - 0111
Cannock, Staffordshire, United Kingdom
Local Institution - 0060
Hull, , United Kingdom
Local Institution - 0114
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-000350-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1247-1367
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM101-863
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.