A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Trial Profile

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Jun 2018

At a glance

  • Drugs Infliximab (Primary)
  • Indications Ulcerative colitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Janssen Biotech
  • Most Recent Events

    • 12 Jun 2018 Results of individual participant data (IPD) pooled analysis of five trials of infliximab and golimumab in UC, to evaluate whether concomitant use of 5-Aminosalicylates modifies clinical outcomes, were published in the American Journal of Gastroenterology.
    • 10 Aug 2014 Status changed from completed to active, no longer recruiting.
    • 16 Oct 2013 Post-hoc analysis for early clinical, laboratory, and endoscopic predictors of sustained steroid-free remission in patients with moderate to severe ulcerative colitis presented at the 21st United European Gastroenterology Week.
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