Describe the level of remission (illness is no longer active, is under control) in patients with ulcerative colitis who are treated with 5-ASA medication

ChAracterizing the Remission status in patients with Ulcerative Colitis treated by 5-ASA - CARUC-ASA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001683-10-BE

Enrollment

200

Registered

2022-08-30

Start date

2022-11-28

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: Claversal Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Trade Name: Claversal Pharmaceutical Form: Suppository INN or Proposed INN: Mesa

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. Subjects currently treated by corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator and investigational drugs for UC 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. 1.1.Subjects currently treated (or within the last 3 months) with above mentioned medication (approved for UC) but taken for another indication than UC, should also be excluded as this could impact UC and study results 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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The percentage of the different levels of remission (complete clinical remission, partial/complete endoscopic remission, histological remission, biological remission, deep remission), in the patients suffering from UC, treated by 5-ASA for at least 6 months, and no concomitant UC medication for at least 3 months, seen in a routine follow-up visit.;Timepoint(s) of evaluation of this end point: At screening/inclusion visit (snapshot);Main Objective: To describe the percentage of the different levels of remission (clinical, endoscopic, histological, biological), in 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.;Secondary Objective: To identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence) To describe the adherence of the patients to the 5-ASA medications and its impact on the remission status To describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact on the remission status. To describe the quality of life of the patients with UC on 5-ASA and its correlation with the level of remission. To understand the implication of patient’s perspective and physician’s perspective in patient lacking deep remission. To analyze the reasons of non-deep remission	—

Measure

Time frame

Primary end point(s): The percentage of the different levels of remission (complete clinical remission, partial/complete endoscopic remission, histological remission, biological remission, deep remission), in the patients suffering from UC, treated by 5-ASA for at least 6 months, and no concomitant UC medication for at least 3 months, seen in a routine follow-up visit.;Timepoint(s) of evaluation of this end point: At screening/inclusion visit (snapshot);Main Objective: To describe the percentage of the different levels of remission (clinical, endoscopic, histological, biological), in 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.;Secondary Objective: To identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence) To describe the adherence of the patients to the 5-ASA medications and its impact on the remission status To describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact on the remission status. To describe the quality of life of the patients with UC on 5-ASA and its correlation with the level of remission. To understand the implication of patient’s perspective and physician’s perspective in patient lacking deep remission. To analyze the reasons of non-deep remission

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Secondary

Measure	Time frame
Secondary end point(s): To identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence). To report the percentage of adherent patients on 5-ASA medications and its impact on the remission status. To report the percentage of prescription of the different 5-ASA regimens (dosage, oral form, association local + oral 5-ASA forms) and its impact on the remission status. To quantify the quality of life of the patients with UC on 5-ASA according to validated Quality of Life scales. To identify factors associated with non-deep remission coming from either physician management or patient perception ;Timepoint(s) of evaluation of this end point: At screening/inclusion visit (snapshot)	—

Measure

Time frame

Secondary end point(s): To identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence). To report the percentage of adherent patients on 5-ASA medications and its impact on the remission status. To report the percentage of prescription of the different 5-ASA regimens (dosage, oral form, association local + oral 5-ASA forms) and its impact on the remission status. To quantify the quality of life of the patients with UC on 5-ASA according to validated Quality of Life scales. To identify factors associated with non-deep remission coming from either physician management or patient perception ;Timepoint(s) of evaluation of this end point: At screening/inclusion visit (snapshot)

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Countries

Belgium

Contacts

Public ContactIngrid Arijs

BIRD vzw

ingrid.arijs@birdgroup.be+320499 31 70 05

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026