InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease

Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease. Primary endpoint: The proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\<150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26. Accrual and feasibility: This study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient/centre/month leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021. Treatment, dosage and administration: Eligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.

NCT Number	NCT06059989
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Collaborators: Celltrion
Conditions	Inflammatory Disease, Disease Crohn, Bowel Disease
Enrollment	158 participants
Start Date	2021-11-25
Primary Completion	2025-06 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-12-10