A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

Trial Profile

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2017

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms OCTAVE; OCTAVEINDUCTION2
  • Sponsors Pfizer
  • Most Recent Events

    • 13 Jul 2017 According to a Pfizer media release, the supplemental New Drug Application (sNDA) for XELJANZ for adult patients with moderately to severely active ulcerative colitis (UC), has been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA. Data from OCTAVE Induction 1, OCTAVE Induction 2, OCTAVE Sustain and OCTAVE Open studies supported the application.
    • 04 May 2017 Results published in the New England Journal of Medicine
    • 03 May 2017 Results published in the Pfizer Media Release
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