ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

BIRD2022001

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.

2023-01-17

2024-02-01

2024-02-01

Completed

Early phase I

200

Inclusion Criteria: 1. Male or female ≥ 18 years 2. Confirmed diagnosis of UC 3. Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the last 3 days before the visit. 4. Recruitment during a routine follow-up visit. 5. 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. 6. Prescription of 5-ASA is within the locally approved Summary of Product Characteristics (SmPCs) 7. Subjects free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3 months 8. Subject or the subject's legally acceptable representative have the capacity to understand and (voluntary) sign an informed consent form 9. Be able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Any subject who meets one of the following criteria will not qualify for entry in the study: 1. 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. 2. Subjects recruited during hospitalization, or via the urgency department for active UC, or during an unscheduled visit for emergency reasons. 3. UC patients with a total colectomy, with or without IPAA 4. Patients with indetermined colitis (IBDU) 5. Women that are pregnant

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'transversal study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}

2024-03-21