NCT05992142CompletedPhase 4
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
Source: ClinicalTrials.gov · Last updated 21 Mar 2024
Brief summary (registry, in English)
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 histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 13 Dec 2022
- Start date
- 17 Jan 2023
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
- Diseases
- Ulcerative colitis
- NCT number
- NCT05992142
- EudraCT number
- 2022-001683-10
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 200
- From 17 Jan 2023 to the primary completion date, 1 Feb 2024
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Any subject who meets one of the following criteria will not qualify for entry in the study:
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imelda Ziekenhuis Coordinator of this site? Confirm its status | Bonheiden | Belgium | Unknown status |
| Hôpital Erasme Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| AZ Sint-Lucas Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| CHU de Liège, site Sart Tilman Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| Groupe Sante CHC/Clinique du MontLegia Coordinator of this site? Confirm its status | Liège | Belgium | Unknown status |
| AZ Voorkempen Malle Coordinator of this site? Confirm its status | Malle | Belgium | Unknown status |
| AZ Damiaan Coordinator of this site? Confirm its status | Ostend | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
| Sint-Andries ziekenhuis Tielt Coordinator of this site? Confirm its status | Tielt | Belgium | Unknown status |
| AZ Vesalius Coordinator of this site? Confirm its status | Tongeren | Belgium | Unknown status |
| AZ Turnhout Coordinator of this site? Confirm its status | Turnhout | Belgium | Unknown status |
| CHU UCL Namur -Site Mont Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.