Switching to subcutaneous infliximab for IBD treatment

Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

This study is testing if switching people with inflammatory bowel disease from an intravenous form of infliximab to a subcutaneous version, given weekly or bi-weekly, can lead to better health results.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 275 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW (other)
• Drugs / interventions: infliximab, inflixmab
• Locations: 15 sites (Ghent, Oost-Vlaanderen and 14 other locations)
• Trial ID: NCT06113913 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of Crohn's disease, ulcerative colitis, or IBD unclassified who are in clinical remission without steroid use.

Not a fit: Patients who are not in remission or those who have not previously received intravenous infliximab may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with IBD by optimizing the administration of infliximab.

How similar studies have performed: Previous studies have shown promising results with subcutaneous infliximab, but this specific approach of switching from intravenous to subcutaneous dosing is relatively novel.

Eligibility criteria

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 this trial is running

Ghent, Oost-Vlaanderen and 14 other locations

• 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)
• AZ Sint-Jan Brugge — Bruges, Belgium (NOT_YET_RECRUITING)
• Erasme — Brussels, Belgium (RECRUITING)
• Ziekenhuis Oost-Limburg — Genk, Belgium (RECRUITING)
• AZ Sint-Lucas Gent — Ghent, Belgium (RECRUITING)
• Universitair ziekenhuis Gent — Ghent, Belgium (RECRUITING)
• Universitair ziekenhuis Leuven — Leuven, Belgium (RECRUITING)
• Heilig Hart ziekenhuis Lier — Lier, Belgium (RECRUITING)
• CHU Liège - Sart Tilman — Liège, Belgium (RECRUITING)
• VITAZ — Sint-Niklaas, Belgium (RECRUITING)
• AZ Vesalius — Tongeren, Belgium (RECRUITING)
• CHwapi — Tournai, Belgium (RECRUITING)

Study contacts

• Principal investigator: Tom Holvoet, MD, PhD — Department of Gastroenterology, VITAZ Sint-Niklaas
• Study coordinator: Ingrid Arijs, Phd

Conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, remission, infliximab