Switching to Mesalazine Monotherapy vs Continuing Thiopurines in Older Patients With Ulcerative Colitis in Sustained Remission: A Multicenter Randomized Controlled Trial (IDEA)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 304
- 主要终点
- Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Ulcerative proctitis (maximum observed extension <25 cm throughout the course of the disease)
- •History of colectomy or imminent need for surgery.
- •Presence of ileoanal reservoir
- •History of complex perianal disease
- •Intolerance to oral 5-ASA treatment
- •Previous or concomitant biologic anti-TNF (vedolizumab, Ustekinumab) or JAK-inhibitor therapy for any condition.
- •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).
- •Any condition that in the investigator's opinion may compromise study participation.
研究组 & 干预措施
Discontinuation Arm
Immediate cessation of thiopurine therapy while continuing standard mesalamine
干预措施: Discontinuation of thiopurines. (Drug)
Continuation Arm
Maintenance of current thiopurine dose together with mesalamine.
结局指标
主要结局
Biologic Relapse at 24 Months in Elderly UC Patients After Thiopurine Discontinuation
时间窗: From enrollment to the end of treatment suspension at 24 months.
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.
次要结局
未报告次要终点