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: 08 Mar 2018

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms OCTAVE; OCTAVE Induction 1
  • Sponsors Pfizer
  • Most Recent Events

    • 08 Mar 2018 According to a Pfizer media release, the company also voted on a post-marketing efficacy study comparing a tofacitinib 10 mg BID continuous dosing regimen versus a regimen of tofacitinib 10 mg BID induction and 5 mg BID as maintenance in this patient population.
    • 08 Mar 2018 Pfizer announced a positive outcome from US FDA GIDAC meeting to discuss sNDA for XELJANZ for the treatment of adult patients with moderately to severely active ulcerative colitis. The GIDAC voted on two dosing questions related to the use of the 10 mg (BID) dose beyond the 8-week induction period and 10 mg BID as continuous maintenance treatment for adult patients with an inadequate response, loss of response or intolerance to TNF blocker therapy.
    • 12 Dec 2017 According to a Pfizer media release, U.S. Food and Drug Administration (FDA) has extended the action date by three months for the supplemental New Drug Application (sNDA) for XELJANZ (tofacitinib), for adult patients with moderately to severely active ulcerative colitis (UC). Anticipated Prescription Drug User Fee Act (PDUFA) date in June 2018.
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