UCNot yet recruiting
Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission
Phase 4 · Testing Discontinuation of thiopurines. · Sites not listed yet · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Discontinuation of thiopurines. (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 60 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 6 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 304 participants are expected to take part.
- Start date: 2026-05-01 (planned).
- Main results expected around 2026-09 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation (From enrollment to the end of treatment suspension at 24 months.)
In the researchers’ words
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.
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 | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Enrollment | 304 (estimated) |
| Start date | 2026-05-01 |
| Primary completion (est.) | 2026-09 |
| First posted | 2025-11-25 |
| Last updated | 2026-04-15 |
| Official title | Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients With Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA) |
| ClinicalTrials.gov ID | NCT07248644 |
Interventions
- Discontinuation of thiopurines. (Drug)
Because thiopurine-related toxicity rises with age while late-onset UC tends to be less aggressive, replacing thiopurines with high-dose oral mesalazine (≥ 3 g/day) may preserve remission and simultaneously reduce long-term oncological and infectious risks.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Male or female patients aged ≥60 years at screening. 2. Established diagnosis of ulcerative colitis according to ECCO criteria. 3. Clinical and endoscopic remission ≥12 months (Mayo score ≤2, subscore ≤1) according to clinical practice. 4. 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. 5. In case of concomitant treatment with oral mesalazine, the dose must´ve been stable for ≥12 months. 6. 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). 7. Colonoscopy performed within 6 months prior to the start of the study in endoscopic remission (Mayo endoscopic index 0) according to clinical practice. 8. Two consecutive (centralised determinations in the period of one month) basal faecal calprotectin values <150 mg/kg during screening. 9. Written informed consent. Exclusion Criteria: 1. Ulcerative proctitis (maximum observed extension <25 cm throughout the course of the disease) 2. History of colectomy or imminent need for surgery. 3. Presence of ileoanal reservoir 4. History of complex perianal disease 5. Intolerance to oral 5-ASA treatment 6. Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition. 7. Severe chronic renal insufficiency, defined as serum creatinine ≥ 2 mg/dL (estimated glomerular filtration rate ≤ 30 mL/min/1.73 m²). 8. Abnormal hepatic laboratory parameters, defined as AST, ALT, alkaline phosphatase, or GGT > 2X the upper limit of normal (ULN) at screening. 9. Hematologic abnormalities at screening, defined as any of the following: absolute neutrophil count < 1,500 cells/mm³, lymphocytes < 500 cells/mm³, platelets < 120,000 cells/mm³, or haemoglobin < 12 g/dL (females) / < 13 g/dL (males). 10. Any condition that in the investigator's opinion may compromise study participation.
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.