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

May 27, 2025 updated by: Seung Min Hong, Pusan National University Hospital

Optimizing IBD Management: A Comparative Study on the Efficacy and Safety of 5-ASA De-escalation in Patients With Ulcerative Colitis and Crohn's Disease on Stable Biologic or Immunomodulator Therapy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In inflammatory bowel disease (IBD), 5-aminosalicylic acid (5-ASA) is widely used as a first-line treatment for ulcerative colitis (UC) and is still prescribed for Crohn's disease (CD). However, for patients who do not respond to conventional therapy, anti-tumor necrosis factor (anti-TNF) agents have become an effective alternative. This has led to ongoing debate about whether continued use of 5-ASA is necessary after transitioning to anti-TNF therapy.

Recent retrospective studies have reported that discontinuing 5-ASA after initiating anti-TNF therapy in UC and CD patients does not increase the risk of clinical adverse outcomes such as new steroid use, hospitalization, or bowel surgery. However, a study based on U.S. data had a median follow-up period of less than one year, making it difficult to assess long-term effects. Additionally, studies on relapse risk after discontinuing 5-ASA have identified younger age, extensive disease, and frequent relapses as risk factors, but detailed analyses for patients receiving anti-TNF therapy remain insufficient.

Another critical issue is the economic burden of continued 5-ASA treatment. In South Korea, the annual cost of the most commonly used 5-ASA formulations constitutes a significant portion of overall healthcare expenses. Discontinuing 5-ASA could reduce treatment costs, simplify therapy, improve patient adherence, and minimize adverse effects associated with polypharmacy. Regarding colorectal cancer (CRC) prevention, recent trends indicate a decreasing incidence of CRC in IBD patients. Since mucosal inflammation is considered a primary driver of CRC, additional 5-ASA use may not be necessary if mucosal healing is achieved through biologics or small-molecule therapies.

Accordingly, this study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dong Hoon Baek, M.D., Ph.D.
  • Phone Number: +82-10-4592-1120
  • Email: dhbeak77@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5-ASA Discontinuation Group
The group discontinuing 5-ASA.
Other: Discontinuation of 5-ASA
Discontinuation of 5-ASA from the time of study enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease relapse rate
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum C-reactive protein (CRP) level
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months
Changes in fecal calprotectin level
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months
Number of hospitalizations
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months
Number of emergency department visits
Time Frame: Through study completion, an average of 9 months
Through study completion, an average of 9 months
Quality of life assessment (32-Item Inflammatory Bowel Disease Questionnaire)
Time Frame: Through study completion, an average of 9 months
Bowel symptoms (Stool frequency, loose stool, abdominal bloating and pain, excessive flatulence, rectal bleeding, urge to defecate, nausea), Systemic symptoms (Fatigue, lack of energy, sleep problems, weight maintenance, general health), Emotional function (Worry, anxiety, frustration, restlessness, depression, stress, embarrassment, anger), Social function (Ability to engage in social activities, work/school, sexual activity)
Through study completion, an average of 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Seung Min Hong, M.D., Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2412-015-145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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