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Active (not recruiting) Phase 3 NCT04909801

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

Phase 3 – large-scale trial before approval
Conditions: Rheumatoid Arthritis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period * 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: * 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., 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 Other protocol-defined inclusion/exclusion criteria apply
Locations 14
Argentina (1)
Local Institution - 0012
CABA , Buenos Aires
Australia (1)
Local Institution - 0072
Botany , New South Wales
Czech Republic (1)
Local Institution - 0028
Brno
France (1)
Local Institution - 0001
Montpellier
Germany (1)
Local Institution - 0059
Berlin
Italy (1)
Local Institution - 0083
Catania
Japan (1)
Local Institution - 0093
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0017
Guadalajara , Jalisco
Poland (1)
Local Institution - 0020
Torun , Kuyavian-Pomeranian Voivodeship
Spain (1)
Local Institution - 0004
A Coruña
Switzerland (1)
Local Institution - 0049
Basel
Taiwan (1)
Local Institution - 0098
Kaohsiung Niao Sung Dist
United Kingdom (1)
Local Institution - 0111
Cannock , Staffordshire
United States (1)
Local Institution - 0036
Fullerton , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.09.2021
Completion date
01.09.2027
Registry ID
NCT04909801
Source
anzctr
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