Subcutaneous infliximab after a previous intravenous dose optimization (AMARETTO trial)

Phase 1

Recruiting

• Conditions: lcerative colitis (UC), Inflammatory bowel disease type unclassified (IBDU) and Crohn's disease (CD); MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947; MedDRA version: 20.1Level: PTClassification code: 10021972Term: Inflammatory bowel disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-508166-15-00
• Lead Sponsor: Belgian IBD Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

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 dosing schedule for at least 20 weeks., Patients receiving an average IV infliximab per eight weeks based on the two most recent IV administrations of more than 8 mg/kg, but not more than 20 mg/kg., Patients who speak and read fluently Dutch, French or English., Patients who is able to voluntary give their written informed consent.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified