Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Status:
Active, not recruiting
Trial end date:
2026-11-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab
in patients with inflammatory bowel disease (IBD) that were previously treated with an
optimized dose of intravenous infliximab.
The main question it aims to answer is:
- Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better
outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab
in patients who received an optimized intravenous dosing schedule?
Participants will switch from intravenous infliximab to subcutaneous infliximab and will be
randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional
comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical
practice in the monitoring for clinical and biological remission.
The participants that are willing to switch to subcutaneous infliximab will be compared to a
group of participants not willing to switch. These participants will continue to be treated
with their optimized intravenous dose of infliximab.
Phase:
Phase 4
Details
Lead Sponsor:
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW