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
Phase of Trial: Phase III
Latest Information Update: 08 Aug 2018
At a glance
- Drugs Tofacitinib (Primary)
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms OCTAVE; OCTAVE INDUCTION2
- Sponsors Pfizer
- 01 Aug 2018 According to a Pfizer media release, the European Commission (EC) has approved XELJANZ 10 mg BID for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID. Data from three pivotal phase 3 studies (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) and OCTAVE Open extension study supported the approval.
- 30 May 2018 According to a Pfizer media release, the US FDA has approved XELJANZ (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients with moderately to severely active ulcerative colitis.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History