Patients and study design
Full details of the OCTAVE Induction 1 and 2 (ClinicalTrials.gov; NCT01465763 and NCT01458951) and OCTAVE Sustain (ClinicalTrials.gov; NCT01458574) study designs were reported previously [This post hoc analysis included patients in the full analysis set (FAS), defined as patients who received tofacitinib or placebo in OCTAVE Induction 1 and 2 and who were re-randomized to receive tofacitinib or placebo in OCTAVE Sustain, and who had a MES of 0 or 1 (based on central reading of endoscopy) at OCTAVE Sustain baseline (Week 8 of OCTAVE Induction 1 and 2).The trial protocol for OCTAVE Sustain has previously been published [