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A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs W...

Mise à jour : Il y a 5 ans
Référence : EUCTR2004-005102-68

A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects with Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have An Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options. Revised Protocol 3, incorporating Amendments 2, 3 and 8. + Protocol Amendments 1 & 5. + Protocol Amendment 11 - Site specific: All sites in Belgium (v1.0, dated 23-Sep-2008)

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Extrait

Summarize incidence of adverse events/serious adverse events/discontinuations due to adverse events during 6 months of combined treatment with abatacept and 1 or more background non-biologic DMARDs approved for RA in subjects with active RA Long-Term Extension(Amdt 5) Assess long-term safety + tolerability of abatacept in subjects that completed the initial 6-month open-label treatment period. This amendment also allows continuous safety monitoring of abatacept

Critère d'inclusion

  • RHEUMATOID ARTHRITIS,NOS

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