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A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthrit...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-005434-37

A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

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Extrait

The primary objective for this study is to demonstrate that subcutaneous (SC) injections of abatacept are non-inferior to intravenous (IV) infusions of abatacept in ACR 20 responses after 6 months of treatment in subjects who have active RA, are receiving methotrexate and experiencing an inadequate response to methotrexate. The primary objective of the LT phase of the study is to assess the safety and long-term tolerability of SC injections of abatacept in subjects who have completed the initial 6-month treatment period.

Critère d'inclusion

  • RHEUMATOID ARTHRITIS,NOS

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