Overview

Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous as Induction Therapy in Patients With Active CD or UC

Status:
RECRUITING
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to compare induction treatment with CT-P13 SC to induction treatment with CT-P13 IV in terms of pharmacokinetics in adult patients with inflammatory bowel disease (IBD) who have been diagnosed for at least 3 months and for whom the physician has decided to initiate treatment with infliximab CT-P13 as part of the standard of care. The main aim of this study is to demonstrate that induction treatment with CT-P13 SC is non-inferior to CT-P13 IV in terms of pharmacokinetics at Week 6.
Phase:
PHASE3
Details
Lead Sponsor:
CMC Ambroise Paré
Collaborators:
Celltrion HealthCare France
Paris IBD Center
Treatments:
CT-P13