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Clinical Trials in the UK / NCT04909801
Active, not recruiting Phase 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

NCT04909801 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2021-09-15
Last updated
2025-02-19

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

AbataceptAdalimumabMethotrexate

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)

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (75)

FacilityCityRegionStatus
Local Institution - 0036 Fullerton California
Local Institution - 0086 Los Alamitos California
Local Institution - 0041 Aurora Colorado
Local Institution - 0058 Cumberland Maryland
Local Institution - 0038 Hagerstown Maryland
Local Institution - 0084 Eagan Minnesota
Local Institution - 0040 Freehold New Jersey
NYU Langone Ambulatory Care Brooklyn Heights Brooklyn New York
Local Institution - 0082 Wilmington North Carolina
Local Institution - 0127 Portland Oregon
Local Institution - 0031 Duncansville Pennsylvania
Local Institution - 0034 Jackson Tennessee
Local Institution - 0044 Dallas Texas
Local Institution - 0119 Milwaukee Wisconsin
Local Institution - 0012 CABA Buenos Aires
Local Institution - 0016 Quilmes Buenos Aires
Local Institution - 0014 San Isidro Buenos Aires
Local Institution - 0057 San Miguel de Tucumán Tucumán Province
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
Local Institution - 0062 Parramatta New South Wales
Local Institution - 0063 Maroochydore Queensland
Local Institution - 0102 Woodville South South Australia
Local Institution - 0064 Camberwell Victoria
Local Institution - 0065 Geelong Victoria
Local Institution - 0105 Ivanhoe Victoria
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

+ 35 more sites — see the full list on the official registry below.

On this site

📄 Orencia (abatacept) drug profile → 📄 Humira (adalimumab) drug profile →

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04909801 on ClinicalTrials.gov ↗ ← All trials in the UK