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Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
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
Infliximab
Weekly administration of subcutaneous infliximab.
Infliximab
Bi-weekly administration of subcutaneous infliximab.
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