Phase Ib, Multicenter, Randomized, Open-Label, Parallel-Group Study to Characterize the Pharmacokinetics of a Single Dose of Abatacept 125 mg Administered Subcutaneously Using the BD Physioject™ Autoinjector or the UltraSafe Passive Needle Guard Prefilled Syringe

CompletadoFase 1ClinicalTrials.gov

ID: NCT01890473Tipo: INTERVENTIONALInicio: 1 de jul de 2013Fin estimado: 1 de nov de 2014

Traducción no disponible, mostrando original

Resumen

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

Descripción detallada

SC=Subcutaneous

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Subjects ≥18 years of age
Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
Disease activity under control

Criterios de exclusión

Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of enrollment
Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer
Current or prior use of Rituximab ≤6 months
Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil \& d-Penicillamine

Intervenciones

drug

Abatacept

Ubicaciones

Local Institution

San Fernando, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Córdoba, Córdoba 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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