NCT06113913 Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
| NCT ID | NCT06113913 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 275 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 275 participants in total. It began in 2024-04-09 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Tom Holvoet, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Gastroenterology, VITAZ Sint-Niklaas
Frequently Asked Questions
Who can join the NCT06113913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06113913 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06113913 currently recruiting?
Yes, NCT06113913 is actively recruiting participants. Contact the research team at ingrid.arijs@birdgroup.be for enrollment information.
Where is the NCT06113913 trial being conducted?
This trial is being conducted at Ghent, Belgium, Ostend, Belgium, Antwerp, Belgium, Bonheiden, Belgium and 11 additional locations.
Who is sponsoring the NCT06113913 clinical trial?
NCT06113913 is sponsored by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW. The principal investigator is Tom Holvoet, MD, PhD at Department of Gastroenterology, VITAZ Sint-Niklaas. The trial plans to enroll 275 participants.