A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Aug 2017

At a glance

  • Drugs Vedolizumab (Primary) ; Ciprofloxacin
  • Indications Pouchitis
  • Focus Therapeutic Use
  • Acronyms EARNEST
  • Sponsors Takeda
  • Most Recent Events

    • 12 Jul 2017 Planned number of patients changed from 200 to 110.
    • 08 Jun 2017 Planned End Date changed from 30 Sep 2019 to 9 Mar 2019.
    • 08 Jun 2017 Planned primary completion date changed from 30 Sep 2019 to 9 Mar 2019.
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