A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT00929864Tipo: INTERVENTIONALInicio: 1 de oct de 2009Fin estimado: 1 de nov de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
Methotrexate failure
Naive to RA biologics
≤5 years duration of disease
Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
Willingness to self-inject subcutaneous (SC) drug

Criterios de exclusión

Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
History of active or chronic hepatitis
Cancer in the last 5 years
History of severe chronic or recurrent bacterial or viral infections
Risk of tuberculosis
Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease

Intervenciones

drug

Abatacept

Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)

drug

Adalimumab

Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)

Ubicaciones

Local Institution

Ciudad Autonoma de Beunos Aire, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma, Buenos Aires, Argentina

Local Institution

Quilmes, Buenos Aires, Argentina

Local Institution

Cordoba, Crd, Córdoba Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

San Juan, San Juan Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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