An interventional study of Discontinuation of 5-ASA in Ulcerative Colitis (UC), Crohn's Disease and Inflammatory Bowel Disease (IBD), sponsored by Pusan National University Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-05-29.
Sponsored by Pusan National University Hospital · Not applicable, Interventional, and Other
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.
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
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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
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.
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.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group discontinuing 5-ASA.
Other: Discontinuation of 5-ASA
Discontinuation of 5-ASA from the time of study enrollment.
Disease relapse rate
Time frame: Through study completion, an average of 9 months
Changes in serum C-reactive protein (CRP) level
Time frame: Through study completion, an average of 9 months
Changes in fecal calprotectin level
Time frame: Through study completion, an average of 9 months
Number of hospitalizations
Time frame: Through study completion, an average of 9 months
Number of emergency department visits
Time frame: Through study completion, an average of 9 months
Quality of life assessment (32-Item Inflammatory Bowel Disease Questionnaire)
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)
Time frame: Through study completion, an average of 9 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Pusan National University Hospital