Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease

Launched by PUSAN NATIONAL UNIVERSITY HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether stopping a medication called 5-ASA (mesalamine) is safe for patients with inflammatory bowel disease (IBD), which includes conditions like ulcerative colitis (UC) and Crohn's disease (CD). The study will focus on patients who have been stable on other treatments, like biologic therapies or immunomodulators, for at least three months and are currently in remission from their disease. Researchers want to find out if discontinuing 5-ASA can be a good option for managing IBD in the long term without causing harm.

To be eligible for this trial, participants must be adults aged 19 or older who have a confirmed diagnosis of UC or CD and have been on a stable dose of 5-ASA for at least three months. They should also be in clinical remission and not have any severe health conditions that could complicate their participation. If you join the study, you will be monitored closely, and researchers will assess how stopping 5-ASA affects your health over time. It's important to note that this trial is still in the planning stages and is not yet recruiting participants.

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Eligibility criteria

• • Inclusion Criteria
• • 1. Diagnosis
• • o Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) based on standard diagnostic criteria, including clinical, endoscopic, and histologic findings.
• • 2. Treatment Status
• • Patients who have been continuously treated with biologic agents (e.g., anti-TNF agents, integrin inhibitors, JAK inhibitors) or immunomodulators (e.g., azathioprine, methotrexate) for at least three months.
• • Patients who have been on a stable dose of 5-ASA (mesalamine) for at least three months before study enrollment.
• • 3. Disease Activity
• • o Patients in clinical remission for at least three months, as defined by the Mayo score for UC or the Crohn's Disease Activity Index (CDAI) for CD.
• • 4. Age
• • o Adults aged 19 years or older.
• • 5. Informed Consent
• • o Patients capable of providing written informed consent for study participation.
• • 6. Compliance with Study Protocol
• • o Patients who can adhere to the study protocol and visit schedule.
• • 7. General Health Condition
• • o Patients without severe medical conditions that could impact the study or patient safety, such as significant cardiac, renal, or hepatic diseases.
• • 8. No recent medication changes
• • 9. Patients who have not had any new prescriptions or dose adjustments of corticosteroids, antibiotics, or other medications that could affect IBD within a specified period (e.g., four weeks) before enrollment.
• • Exclusion Criteria
• • 1. Patients with severe active UC or CD at the time of study enrollment.
• • 2. Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.
• • 3. Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.
• • 4. Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).
• • 5. Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.
• • 6. Pregnant or breastfeeding women.
• • 7. Patients with known allergies or intolerance to 5-ASA or related medications.
• • 8. Patients currently participating in another clinical study that may interfere with this study.
• • 9. Patients unable to provide informed consent or unlikely to comply with the study protocol and visit schedule.
• • 10. Patients with a history of non-response or intolerance to their current biologic or immunomodulator therapy.
• • 11. Patients with a history of severe psychiatric disorders that may affect their ability to participate in the study.