A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis

Trial Profile

A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jan 2018

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions
  • Acronyms OCTAVE; OCTAVE long-term; OCTAVE Open
  • Sponsors Pfizer
  • Most Recent Events

    • 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.
    • 01 Nov 2017 Interim safety and efficacy results up to 3 years of treatment with Tofacitinib (as of 08 July 2016, n=914), presented at the 25th United European Gastroenterology Week.
    • 01 Nov 2017 Results of an integrated analysis assessing safety of Tofacitinib in NCT00787202, NCT01458574, NCT01458951, NCT01465763 and NCT01470612 (n=1240) presented at the 25th United European Gastroenterology Week
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