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Pesquisa Study Connect

Active, Not Recruiting

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 - IM101-863

Atualizado: 2 novembro, 2023   |

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Detalhes do estudo

  • Phase 3


  • Gênero(s)

  • 18+

    Faixa etária

  • Active, Not Recruiting

Opções de tratamento

Braços de tratamento do Estudo
Experimental: Arm 1: Abatacept + Methotrexate
Drug: Methotrexate, Abatacept
Experimental: Arm 2: (Adalimumab + Methotrexate) followed by (Abatacept + Methotrexate)
Drug: Abatacept, Methotrexate, Adalimumab

Principais critérios de elegibilidade

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit 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

É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas

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