臨床研究等提出・公開システム

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

Abatacept vs Adalimumab in Early, Seropositive, and SE-positive RA (IM101-863)

Maldonado A Michael

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Maldonado A Michael

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Complete

Oct. 11, 2021

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

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
Naive 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(>=7.5mg/week) of oral or parenteral MTX for at least 4 weeks prior to randomization
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3x 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

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

Both

Rheumatoid Arthritis

Single-blind Treatment Period
Arm A Abatacept+MTX
Arm B Adalimumab+MTX
Open-label Treatment Period
Abatacept+MTX

achieving clinical response(ACR50) at Week 24

achieving clinical remission criteria (DAS28-CRP remission) at Week 24

+81-93-691-7503

July. 13, 2021

No

Australia/France/Germany/USA/Taiwan