RecruitingPhase 3NCT06059989

InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease

A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

158 participants

Start Date

Nov 25, 2021

Study Type

INTERVENTIONAL

Conditions

Inflammatory Disease Bowel Disease Disease Crohn

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a subcutaneous (under-the-skin injection) form of infliximab, an anti-inflammatory medication, as an induction treatment for patients with moderate to severe Crohn's disease. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Crohn's disease - Your Crohn's disease is moderately to severely active - You have visible ulcers in your gut confirmed by endoscopy - You have tried and failed, lost response to, or had intolerable side effects from prior treatments (steroids, thiopurines like azathioprine, or other biologics) **You may NOT be eligible if...** - You are currently responding well to existing treatments - You have active infections such as tuberculosis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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