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 follow-up.
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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