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

Trial Profile

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With 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 Sustain
  • Sponsors Pfizer
  • Most Recent Events

    • 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.
    • 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.
    • 01 Nov 2017 Results describing clinical efficacy endpoints assessed by local endoscopy readings and previously reported results assessed by central readings presented at the 25th United European Gastroenterology Week
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