Status:
RECRUITING
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Lead Sponsor:
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborating Sponsors:
Celltrion
Conditions:
Inflammatory Bowel Diseases
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 in...
Detailed Description
Inflammatory bowel diseases (IBD) are a group of immune mediated disorders primarily targeting the gastro-intestinal tract and consist of two distinct phenotypes: Crohn's disease (CD) and ulcerative c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06113913
Start Date
April 9 2024
End Date
November 1 2026
Last Update
July 26 2024
Active Locations (15)
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1
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
2
AZ Oostende
Ostend, West-Vlaanderen, Belgium
3
Universitair ziekenhuis Antwerpen
Antwerp, Belgium
4
Imeldaziekenhuis
Bonheiden, Belgium