NCT07248644

Immunosuppressant Discontinuation in Elderly Patients With Ulcerative Colitis And Long-term Remission

Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients With Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA)

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study population and total sample size: 304 patients aged ≥ 60 years with ulcerative colitis in sustained clinical remission while on long-term thiopurine therapy. Treatment strategies Group 1 - Continuation of thiopurines (± baseline oral mesalazine). Group 2 - Discontinuation of thiopurines and initiation/maintenance of oral mesalazine at a dose of 4 g/day. Patients will attend a screening visit, a baseline visit (Day 0), and subsequently follow-up visits every 4 months until month 24. Fecal calprotectin will be measured at each visit according to standardized and validated procedures. The occurrence of relapse will lead to discontinuation of the patient's participation in the trial. Thereafter, rescue therapy will be initiated at the investigator's discretion and outside the scope of the study.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	Discontinuation of thiopurines.	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-11-25
• Last updated: 2026-04-15