ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA (CARUC-ASA)
Ulcerative Colitis
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring remission, 5-aminosalicylate acid (5-ASA)
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Imelda ZiekenhuisRecruiting
- Hôpital ErasmeRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Ziekenhuis Oost-LimburgRecruiting
- AZ Sint-Lucas GentRecruiting
- Universitair Ziekenhuis GentRecruiting
- AZ GroeningeRecruiting
- CHU de Liège - Site Sart TilmanRecruiting
- Groupe santé CHC Clinique du MontLégiaRecruiting
- AZ Voorkempen MalleRecruiting
- AZ DamiaanRecruiting
- AZ DeltaRecruiting
- Sint-Andries ziekenhuis TieltRecruiting
- AZ VesaliusRecruiting
- AZ TurnhoutRecruiting
- CHU UCL Namur -Site Mont GodinneRecruiting
Arms of the Study
Arm 1
Other
UC patients
UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit