Status:
COMPLETED
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
Lead Sponsor:
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and...
Detailed Description
The management of inflammatory bowel diseases aims to induce not only a clinical corticosteroid-free remission but also a deep remission defined by the achievement of mucosal healing. In ulcerative co...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years
- Confirmed diagnosis of UC
- Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the last 3 days before the visit.
- Recruitment during a routine follow-up visit.
- Subjects to whom 5-ASA treatment has been prescribed for at least 6 months (any type of oral and/or rectal 5 ASA, any dosage) and with the dose of 5-ASA stable for at least 2 weeks (including suppositories) prior to inclusion.
- Prescription of 5-ASA is within the locally approved Summary of Product Characteristics (SmPCs)
- Subjects free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3 months
- Subject or the subject's legally acceptable representative have the capacity to understand and (voluntary) sign an informed consent form
- Be able to adhere to the study visit schedule and other protocol requirements
Exclusion
- Any subject who meets one of the following criteria will not qualify for entry in the study:
- Subjects currently treated by immunomodulators, biologics, JAK inhibitors, S1PR modulator and investigational drugs and within the last three months. A history of immunomodulator or biologic or JAK inhibitor or S1PR modulator and investigational drugs use in the past is not an exclusion criteria.
- Subjects recruited during hospitalization, or via the urgency department for active UC, or during an unscheduled visit for emergency reasons.
- UC patients with a total colectomy, with or without IPAA
- Patients with indetermined colitis (IBDU)
- Women that are pregnant
Key Trial Info
Start Date :
January 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05992142
Start Date
January 17 2023
End Date
February 1 2024
Last Update
March 21 2024
Active Locations (16)
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1
Imelda Ziekenhuis
Bonheiden, Belgium
2
Hôpital Erasme
Brussels, Belgium
3
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
4
Ziekenhuis Oost-Limburg
Genk, Belgium