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

ConditionsUlcerative Colitis (UC)Crohn's Disease Inflammatory Bowel Disease (IBD)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorPusan National University Hospital

About this trial

This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region. It seeks to determine whether discontinuing 5-ASA is a safe treatment strategy in modern IBD management.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis

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.

Disqualifiers

Patients with severe active UC or CD at the time of study enrollment.

Patients who have been recently hospitalized for IBD-related reasons or undergone IBD-related surgery within three months before enrollment.

Patients who have had dose modifications of biologics, immunomodulators, or corticosteroids for IBD within three months before enrollment.

Patients receiving concomitant therapy with other medications that may affect disease activity (e.g., additional anti-inflammatory agents, IBD-related antibiotics).

Trial design

Design model

Single group

Treatments tested in this trial

Discontinuation of 5-ASA
Other intervention
Discontinuation of 5-ASA from the time of study enrollment.

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: 5-ASA Discontinuation GroupExperimental treatment 1 intervention