Tofacitinib Demonstrates Efficacy for Potential UC Indication
The Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) global clinical development program includes three Phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain, as well as a long-term extension trial, OCTAVE Open. OCTAVE Induction 1 and OCTAVE Induction 2 are identical Phase 3 placebo-controlled studies evaluating induction of remission by tofacitinib 10 mg twice daily tablets in 598 adults with moderate to severe UC.
OCTAVE Induction 1 and OCTAVE Induction 2 met their primary endpoints as measured by the proportion of patients receiving tofacitinib in remission at Week 8 compared to patients receiving placebo. Detailed analyses of the studies will be submitted for presentation at a future scientific meeting. Results for OCTAVE Sustain are anticipated by the end of 2016.
Tofacitinib is a Janus Kinase (JAK) Inhibitor. It is currently indicated for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
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