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An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis

Trial Profile

An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Nov 2023

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At a glance

  • Drugs Infliximab (Primary) ; Infliximab
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Celltrion
  • Most Recent Events

    • 17 Oct 2023 Results comparing discontinuation rates due to lack of efficacy during maintenance treatment with infliximab or vedolizumab in patients with Crohn'S Disease (NCT02883452, NOR-SWITCH, PLANETCD, and LIBERTY-CD) infliximab and two RCTs (GEMINI 2 and VISIBLE 2) on vedolizumab, presented at the 31st United European Gastroenterology Week.
    • 09 May 2023 Results of post hoc analysis of the Randomised Phase I Ct-P13 Sc study presented at the Digestive Disease Week 2023
    • 09 May 2023 Results of studies LIBERTY-UC, NCT02883452, NOR-SWITCH and VISIBLE 1, GEMINI 1, VARSITY; comparing the discontinuation rates due to lack of efficacy between IFX and VDZ, presented at the Digestive Disease Week 2023
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