Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 2/3 Open-label Extension Study to Evaluate Long-Term Safety and Efficacy With VX-509 in a Treat to Target Setting in Subjects With Rheumatoid Arthritis on Disease-Modifying Antirheumatic Drugs
This study is designed to evaluate the long-term safety and tolerability of VX-509 in subjects with active rheumatoid arthritis (RA) on DMARD therapy. This study will enroll subjects who completed a previous designated study with VX-509 (e.g., Study VX12-509-103).
VX-509 is an oral, selective Janus kinase 3 (JAK3) inhibitor being developed by Vertex. In
autoimmune diseases, JAK3 is an essential component of the immune signaling cascade. This
cascade ultimately contributes to abnormal immune response that results in chronic
inflammation and, in the case of rheumatoid arthritis (RA), irreversible damage to cartilage
and bones. Selective inhibition of JAK3 offers a new disease modifying approach to the
treatment of RA.
This study will follow a "treat to target" (T2T) paradigm. T2T strategies have been followed
in non-rheumatologic fields for decades. T2T trials have been conducted for RA from the late
1990's, and have substantiated the concept that treating to a target is associated with a
better outcome than standard of care treatment. This has led to recommendations by experts
to use T2T strategies in clinical practice.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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