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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
304
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.
Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
To compare the biological-relapse rate at 24 months in elderly patients with quiescent ulcerative colitis (UC) in long-term remission who discontinue thiopurines versus those who continue thiopurine therapy.
Time frame: From enrollment to the end of treatment suspension at 24 months.
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