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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04909801Tipo: INTERVENTIONALInicio: 15 de sept de 2021Fin estimado: 1 de sept de 2027

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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
or more joints cannot be assessed for tenderness or swelling

Intervenciones

drug

Abatacept

Abatacept SC (125 mg) once weekly

drug

Adalimumab

Adalimumab SC (40 mg) once every 2 weeks

drug

Methotrexate

Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)

Ubicaciones

Local Institution - 0012

CABA, Buenos Aires, Argentina

Local Institution - 0016

Quilmes, Buenos Aires, Argentina

Local Institution - 0014

San Isidro, Buenos Aires, Argentina

Local Institution - 0057

San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0022

Buenos Aires, Argentina

Local Institution - 0023

Buenos Aires, Argentina

Local Institution - 0015

Buenos Aires, Argentina

Local Institution - 0099

Córdoba, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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