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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2023

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At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms OCTAVE; OCTAVE Sustain
  • Sponsors Pfizer

    • Most Recent Events

    • 17 Oct 2023 Results of matching-adjusted indirect comparisons (MAIC) of the efficacy and safety of Upadacitinib vs Vedolizumab, Ustekinumab and Tofacitinib in the phase 3 maintenance studies U-ACHIEVE, GEMINI-1, UNIFI & OCTAVE Sustain, presented at the 31st United European Gastroenterology Week.
    • 17 Oct 2023 Results of post hoc analysis assessing baseline factors associated with symptomatic remission at Week 8 in patients who received tofacitinib 10 mg twice daily (BID) in OCTAVE Induction 1&2 (NCT01465763; NCT01458951) and compare the efficacy of tofacitinib 5 and 10 mg BID after 52 weeks of maintenance treatment in OCTAVE Sustain presented at the 31st United European Gastroenterology Week
    • 17 Oct 2023 Results assessing final safety analyses from the tofacitinib UC ((NCT00787202; NCT01465763; NCT01458951; NCT01458574,NCT01470612, NCT03281304) presented at the 31st United European Gastroenterology Week
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