A Phase IIIb, Multi-Center, Randomized, Withdrawal Study to Evaluate the Immunogenicity and Safety of Subcutaneous Administered Abatacept in Adults With Active Rheumatoid Arthritis

CompletadoFase 3ClinicalTrials.gov

ID: NCT00533897Tipo: INTERVENTIONALInicio: 1 de nov de 2007Fin estimado: 1 de feb de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of the study is to determine whether subcutaneous abatacept administered to patients with rheumatoid arthritis is associated with increased immunogenicity or increased safety events upon withdrawal and reintroduction.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Clinical diagnosis of Rheumatoid Arthritis
Disease Activity Score (DAS)28-C-Reactive Protein (CRP) score ≥ 3.2 and ≤5.1
On background methotrexate at least 3 months (≥10mg weekly)
Must be able to self injection or allow a care giver to do it for them
Discontinue all Biologics and Disease-Modifying Anti-rheumatic Drugs (DMARDs) except for methotrexate

Criterios de exclusión

Participants who had prior exposure to abatacept or CTLA-4 Ig
Received treatment with rituximab.
Participants who have received treatment with leflunomide within 1 year of screening
Participants who have received treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (Cellcept®), cyclosporine A or other calcineurin inhibitors, or D-Penicillamine.

Intervenciones

drug

Abatacept

Solution in pre-filled syringes, Subcutaneously, 125 mg, Weekly, (Short Term (3 periods - 12 weeks each; Long Term)

drug

Placebo

Solution in pre-filled syringes, Subcutaneously, 0 mg, Weekly, Period II 12 weeks (Short Term)

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Local Institution

Santa Fe, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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