Pfizer announced top-line results from two Phase 3 induction trials of tofacitinib for the treatment of adults with moderate to severe ulcerative colitis (UC).
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.
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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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