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RECRUITING
NCT06113913
PHASE4

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2024-04-09

Completion Date

2026-11

Last Updated

2024-07-26

Healthy Volunteers

No

Interventions

DRUG

Infliximab

Weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Bi-weekly administration of subcutaneous infliximab.

DRUG

Infliximab

Optimized dosing schedule of intravenous infliximab.

Locations (15)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

AZ Oostende

Ostend, West-Vlaanderen, Belgium

Universitair ziekenhuis Antwerpen

Antwerp, Belgium

Imeldaziekenhuis

Bonheiden, Belgium

AZ Sint-Jan Brugge

Bruges, Belgium

Erasme

Brussels, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

AZ Sint-Lucas Gent

Ghent, Belgium

Universitair ziekenhuis Gent

Ghent, Belgium

Universitair ziekenhuis Leuven

Leuven, Belgium

Heilig Hart ziekenhuis Lier

Lier, Belgium

CHU Liège - Sart Tilman

Liège, Belgium

VITAZ

Sint-Niklaas, Belgium

AZ Vesalius

Tongeren, Belgium

CHwapi

Tournai, Belgium