A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease

Trial Profile

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Crohn's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Celltrion
  • Most Recent Events

    • 29 Oct 2017 According to a Celltrion media release, Out of 220 patients 214 patients completed up to week 6 for the primary analysis and 180 patients completed up to week 30. At week 30 approximately half of the patients in each group were switched to the alternative treatment up to 54 weeks. 166 patients completed the study to 54 weeks.
    • 29 Oct 2017 According to a Pfizer media release, data were presented at the 25th United European Gastroenterology (UEG) Week.
    • 28 Mar 2017 Status changed from active, no longer recruiting to completed.
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