NCT04909801Active, not recruitingPhase 3
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
A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment With Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults With Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate
Source: ClinicalTrials.gov · Last updated 19 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (actual)
- First submitted
- 28 May 2021
- Start date
- 15 Sept 2021
- Primary completion date
- 14 Jun 2023
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04909801
- EU CT number
- 2023-506450-20-00
- EudraCT number
- 2020-000350-96
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 338
- From 15 Sept 2021 to the primary completion date, 14 Jun 2023
- 73 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Women who are breastfeeding
- 5 or more joints cannot be assessed for tenderness or swelling
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (73)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.