NCT06691061招募中不适用
Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
Humanitas Clinical and Research Center1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2023年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Clinical and endoscopic effectiveness of the three treatments
研究概览
简要总结
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
- •Age ≥ 18 years-old;
- •Capability of expressing informed consent;
- •Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
- •Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
- •Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
- •No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
- •At least 1 follow-up visit after baseline
排除标准
- •Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
- •Age < 18 years-old;
- •Incapability of expressing informed consent;
- •Acute severe UC requiring hospitalization at baseline;
- •No previous exposure to anti-TNFα therapies;
- •Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
- •Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.
结局指标
主要结局
Clinical and endoscopic effectiveness of the three treatments
时间窗: 12 months
Rates of steroid-free clinical remission and endoscopic remission
次要结局
未报告次要终点
研究者
Alessandro Armuzzi
Professor
Humanitas Clinical and Research Center
研究点 (1)
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