Stopping thiopurine medicines in older people with ulcerative colitis in long-term remission
Compares stopping thiopurines with continuing them in older adults whose ulcerative colitis is controlled.
Plain-language title generated from the registry record
Registry title: Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission
Key facts
- Where
- Badalona, Barcelona, Burgos, Girona, Madrid, Mataro, Motril, Ourense, Sabadell, Santander, Santiago de Compostela, Sevilla, Terrassa, Vigo, and Zaragoza, SpainSee the 15 sites
- Phase
- Phase 4
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainTaking people
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Hospital Universitario De BurgosBurgos, SpainTaking people
- Hospital Universitari de Girona Doctor Josep TruetaGirona, SpainTaking people
- Hospital Universitario La PazMadrid, SpainTaking people
- Consorci Sanitari Del MaresmeMataro, SpainTaking people
- Hospital Santa AnaMotril, SpainTaking people
- Complejo Hospitalario Universitario de OurenseOurense, SpainTaking people
- Parc Tauli Hospital UniversitariSabadell, SpainTaking people
- Hospital Universitario Marqués de ValdecillaSantander, SpainTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Fundacio Assistencial De Mutua De Terrassa FpcTerrassa, SpainTaking people
- Hospital Alvaro CunqueiroVigo, SpainTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Trial code
- NCT07248644EU 2025-524675-23-00
- Record updated
- 15 April 2026
- Original description
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.Read full original descriptionShow less
Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients With Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA)
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.
Inclusion: 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); 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; Written informed consent.
Exclusion: Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition; Ulcerative proctitis (maximum observed extension <25 cm throughout the course of the disease); History of colectomy or imminent need for surgery; History of complex perianal disease; Any condition that in the investigator's opinion may compromise study participation; 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; 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); Presence of ileoanal reservoir; Intolerance to oral 5-ASA treatment.