RecruitingPhase 4NCT06113913

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization


Sponsor

Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

Enrollment

275 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether patients with inflammatory bowel disease (IBD) — specifically Crohn's disease or ulcerative colitis — who have been optimized on intravenous (IV) infliximab can successfully switch to a subcutaneous (under-the-skin) injection form of the same drug. This could make treatment more convenient for patients. **You may be eligible if:** - You have a confirmed diagnosis of Crohn's disease, ulcerative colitis, or indeterminate IBD - You are 18 or older - You are currently in remission (your disease is under control) on IV infliximab, without needing steroids - Your disease has been previously optimized on IV infliximab **You may NOT be eligible if:** - Your disease is currently active or flaring - You have certain serious infections or other major health conditions - You are pregnant or planning to become pregnant during the study - You have had serious reactions to infliximab in the past 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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Interventions

DRUGInfliximab

Weekly administration of subcutaneous infliximab.

DRUGInfliximab

Bi-weekly administration of subcutaneous infliximab.

DRUGInfliximab

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

View Full Details on ClinicalTrials.gov

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NCT06113913


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