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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Apr 2019

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At a glance

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

    • 28 Mar 2019 Results published in the Lancet
    • 24 Oct 2018 Results of post-hoc analysis of n=198 patients who underwent efficacy analysis at Week 54 and had PK parameters at Week 6 (pre-dose concentration at Week 14) and Week 14 (pre-dose concentration at Week 22), presented at the 26th United European Gastroenterology Week.
    • 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.
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