Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remis… (NCT07248644) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission
304 participantsStarted 2026-05-01
Plain-language summary
IDEA is a Phase IV, prospective, randomised, open-label, multicentre clinical trial designed to evaluate the safety and efficacy of withdrawing thiopurines in elderly (≥60 years) patients with ulcerative colitis (UC) who are in sustained clinical and biological remission. The study compares discontinuation of thiopurines versus continuation while maintaining background mesalamine therapy over 24 months of treatment.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female patients aged ≥60 years at screening.
. Established diagnosis of ulcerative colitis according to ECCO criteria.
. Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice.
. Treatment with a thiopurine (azathioprine 1-2.5 mg/kg/day or mercaptopurine 0.75-1.5 mg/kg/day) for ≥60 months. Treatment at stable doses (minimum effective dose without adverse events in the last 12 months.
. In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months.
. Clinical remission (at the discretion of the investigator) for at least 3 years, without the need for treatment with oral or intravenous steroids or biological agents (topical rectal treatments are permitted as well as oral mesalazine if the dose has remained stable over the past 12 months).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
Timeframe: From enrollment to the end of treatment suspension at 24 months.
Trial details
NCT IDNCT07248644
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
. Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice.
. Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values \<150 mg/kg during screening.
Exclusion criteria
. Ulcerative proctitis (maximum observed extension \<25 cm throughout the course of the disease)
. History of colectomy or imminent need for surgery.
. Presence of ileoanal reservoir
. History of complex perianal disease
. Intolerance to oral 5-ASA treatment
. Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition.
. Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg/dL (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²).
. Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT \> 2X the upper limit of normal (ULN) at screening.