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

NCT06878495 | Not Yet Recruiting

• 1 other identifier: 2412-015-145
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ulcerative Colitis (UC); Crohn's Disease; Inflammatory Bowel Disease (IBD)

Keywords

5-ASA Discontinuation; Inflammatory Bowel Disease; Biologic Therapy

Outcome Measures

Primary Outcomes (1)

• Disease relapse rate

  Through study completion, an average of 9 months

Secondary Outcomes (5)

• Changes in serum C-reactive protein (CRP) level

  Through study completion, an average of 9 months

• Changes in fecal calprotectin level

  Through study completion, an average of 9 months

• Number of hospitalizations

  Through study completion, an average of 9 months

• Number of emergency department visits

  Through study completion, an average of 9 months

• Quality of life assessment (32-Item Inflammatory Bowel Disease Questionnaire)

  Through study completion, an average of 9 months

Study Arms (1)

5-ASA Discontinuation Group

EXPERIMENTAL

The group discontinuing 5-ASA.

Other: Discontinuation of 5-ASA

Interventions

Discontinuation of 5-ASA OTHER

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

5-ASA Discontinuation Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis
• o Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) based on standard diagnostic criteria, including clinical, endoscopic, and histologic findings.
• 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.
• 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.
• Age
• o Adults aged 19 years or older.
• Informed Consent
• o Patients capable of providing written informed consent for study participation.
• Compliance with Study Protocol
• o Patients who can adhere to the study protocol and visit schedule.
• 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.

You may not qualify if:

• 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).
• Patients with severe cardiac, renal, or hepatic disease or other medical conditions that could interfere with the study.
• Pregnant or breastfeeding women.
• Patients with known allergies or intolerance to 5-ASA or related medications.
• Patients currently participating in another clinical study that may interfere with this study.
• Patients unable to provide informed consent or unlikely to comply with the study protocol and visit schedule.
• Patients with a history of non-response or intolerance to their current biologic or immunomodulator therapy.
• Patients with a history of severe psychiatric disorders that may affect their ability to participate in the study.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Related Publications (6)

• Seo J, Kim S, Hong SW, Hwang SW, Park SH, Yang DH, Byeon JS, Myung SJ, Yang SK, Kim YJ, Ye BD. Continuing or stopping 5-aminosalicylates in patients with inflammatory bowel disease on anti-TNF therapy: A nationwide population-based study. Aliment Pharmacol Ther. 2024 Aug;60(3):389-400. doi: 10.1111/apt.18102. Epub 2024 Jun 12.

  PMID: 38866064 BACKGROUND

• Chapman TP, Frias Gomes C, Louis E, Colombel JF, Satsangi J. Review article: withdrawal of 5-aminosalicylates in inflammatory bowel disease. Aliment Pharmacol Ther. 2020 Jul;52(1):73-84. doi: 10.1111/apt.15771. Epub 2020 May 26.

  PMID: 32452591 BACKGROUND

• Singh S, Kim J, Zhu W, Dulai PS, Sandborn WJ, Jairath V. No benefit of continuing vs stopping 5-aminosalicylates in patients with ulcerative colitis escalated to anti-metabolite therapy. Aliment Pharmacol Ther. 2020 Aug;52(3):481-491. doi: 10.1111/apt.15876. Epub 2020 Jun 23.

  PMID: 32573825 BACKGROUND

• Ungaro RC, Limketkai BN, Jensen CB, Yzet C, Allin KH, Agrawal M, Ullman T, Burisch J, Jess T, Colombel JF. Stopping Mesalamine Therapy in Patients With Crohn's Disease Starting Biologic Therapy Does Not Increase Risk of Adverse Outcomes. Clin Gastroenterol Hepatol. 2020 May;18(5):1152-1160.e1. doi: 10.1016/j.cgh.2019.08.012. Epub 2019 Aug 13.

  PMID: 31419574 BACKGROUND

• Ungaro RC, Limketkai BN, Jensen CB, Allin KH, Agrawal M, Ullman T, Colombel JF, Jess T. Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts. Gut. 2019 Jun;68(6):977-984. doi: 10.1136/gutjnl-2018-317021. Epub 2018 Nov 12.

  PMID: 30420398 BACKGROUND

• Bernstein CN, Tenakoon A, Singh H, Targownik LE. Continued 5ASA use after initiation of anti-TNF or immunomodulator confers no benefit in IBD: a population-based study. Aliment Pharmacol Ther. 2021 Sep;54(6):814-832. doi: 10.1111/apt.16518. Epub 2021 Jul 11.

  PMID: 34247410 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Seung Min Hong, M.D.

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Min Hong, M.D.

CONTACT

+82-10-2330-8181; lucky77i@naver.com

Dong Hoon Baek, M.D., Ph.D.

CONTACT

+82-10-4592-1120; dhbeak77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 5-ASA Discontinuation Group

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: March 17, 2025
• Study Start: June 15, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share