inDuctIon tREatment With subCuTaneous Infliximab for Crohn's Disease
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)