Switching to subcutaneous infliximab for IBD treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of switching patients with inflammatory bowel disease (IBD) from intravenous infliximab to subcutaneous infliximab. Participants will be randomized to receive either a weekly or bi-weekly subcutaneous dose after previously optimized intravenous treatment. The study aims to determine if the weekly dosing leads to better clinical outcomes compared to the standard bi-weekly administration. Monitoring will focus on achieving clinical and biological remission throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.
* Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria
* Males and females ≥18 years old.
* Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks.
* Patients must be in biological remission at screening defined as a CRP \<10 mg/L and a fecal calprotectin \<250 µg/g.
* Patients receiving IV infliximab for at least 26 consecutive weeks.
* Patients receiving a stable IV infliximab dosing schedule for at least 20 weeks.
* Patients receiving an average IV infliximab dose per 8 weeks based on the two most recent IV administration of more than 8 mg/kg, but not more than 22 mg/kg
* Patients who speak and read fluently Dutch, French or English.

Exclusion Criteria:

* Male or female ≤ 18 years
* Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy
* Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device
* Patients previously treated with SC infliximab
* Patients with active perianal fistulizing disease
* Patients with microscopic colitis

Where it's running

• AZ Maria Middelares
  Ghent, Oost-Vlaanderen, Belgium Recruiting
• AZ Oostende
  Ostend, West-Vlaanderen, Belgium Recruiting
• Universitair ziekenhuis Antwerpen
  Antwerp, Belgium Recruiting
• Imeldaziekenhuis
  Bonheiden, Belgium Recruiting
• Erasme
  Brussels, Belgium Recruiting
• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting

Study contacts

• Principal investigator: Tom Holvoet, MD, PhD — Department of Gastroenterology, VITAZ Sint-Niklaas
• Study coordinator: Ingrid Arijs, Phd
• Email: ingrid.arijs@birdgroup.be
• Phone: +32499317005

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.