Crohn'sUCNot yet recruiting
Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
Not applicable · Testing Discontinuation of 5-ASA · Sites not listed yet · Pusan National University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Discontinuation of 5-ASA. Condition(s) listed: Ulcerative Colitis (UC), Crohn's Disease and Inflammatory Bowel Disease (IBD).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 19 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 14 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 100 participants are expected to take part.
- Start date: 2025-06-15 (planned).
- Main results expected around 2025-12-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Disease relapse rate (Through study completion, an average of 9 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Crohn's Disease; Inflammatory Bowel Disease (IBD) |
| Lead sponsor | Pusan National University Hospital |
| Enrollment | 100 (estimated) |
| Start date | 2025-06-15 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2025-03-17 |
| Last updated | 2025-05-29 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06878495 |
Interventions
- Discontinuation of 5-ASA (Other)
Discontinuation of 5-ASA from the time of study enrollment.
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.