Ulcerative Colitis (UC)NCT06878495
Efficacy and Safety of Discontinuing 5-ASA in Patients With Inflammatory Bowel Disease
A study testing Discontinuation of 5-ASA in people with Ulcerative Colitis (UC) and Crohn's Disease, run by Pusan National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn's Disease, Inflammatory Bowel Disease (IBD)
- What is being tested?
- Discontinuation of 5-ASA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- No recent medication changes
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- Discontinuation of 5-ASA
- Keywords
- 5-ASA Discontinuation, Inflammatory Bowel Disease, Biologic Therapy
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of 5-ASAOther
Discontinuation of 5-ASA from the time of study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| 5-ASA Discontinuation Group | Experimental | The group discontinuing 5-ASA. Receives: Other: Discontinuation of 5-ASA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease relapse rate
Measured: Through study completion, an average of 9 months
Secondary outcomes (5)
Changes in serum C-reactive protein (CRP) level
Measured: Through study completion, an average of 9 months
Changes in fecal calprotectin level
Measured: Through study completion, an average of 9 months
Number of hospitalizations
Measured: Through study completion, an average of 9 months
Number of emergency department visits
Measured: 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)
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5-ASA Discontinuation Group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Min Hong, Pusan National University Hospital
- Investigators
- Seung Min Hong, M.D., Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878495
- Sponsor's protocol ID
- 2412-015-145
- Status last verified
- May 2025
- First submitted
- 2 Feb 2025
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38866064Chapman 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.
PubMed 32452591Singh 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.
PubMed 32573825Ungaro 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.
PubMed 31419574Ungaro 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.
PubMed 30420398Bernstein 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.
PubMed 34247410
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2412-015-145
- Keywords
- 5-ASA Discontinuation, Inflammatory Bowel Disease, Biologic Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5-ASA Discontinuation Group
| Arm | Type | Receives |
|---|---|---|
| 5-ASA Discontinuation Group | Experimental | Other: Discontinuation of 5-ASAThe group discontinuing 5-ASA. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of 5-ASADiscontinuation of 5-ASA from the time of study enrollment. | Other | 5-ASA Discontinuation Group |
Primary outcome
Disease relapse rate
Time frame: Through study completion, an average of 9 months
5 secondary outcomes
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)
Time frame: Through study completion, an average of 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Results publication: PubMed 38866064Seo 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.
- Results publication: PubMed 32452591Chapman 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.
- Results publication: PubMed 32573825Singh 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.
- Results publication: PubMed 31419574Ungaro 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.
- Results publication: PubMed 30420398Ungaro 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.
- Results publication: PubMed 34247410Bernstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seung Min Hong, M.D. principal investigator
Pusan National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of 5-ASA in people with Ulcerative Colitis (UC) and Crohn's Disease, run by Pusan National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Min Hong, M.D. (+82-10-2330-8181, lucky77i@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease relapse rate (time frame: Through study completion, an average of 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06878495, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.