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临床试验/NCT05186623
NCT05186623招募中不适用

Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Response to induction therapy

研究概览

简要总结

This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.

详细描述

In this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. In the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. Before drug administration (week 0), baseline lower GI endoscopy will be performed and colon tissues will be collected. Blood sample and fecal sample will also be collected. After induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. Combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. Similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features
  • Patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment

排除标准

  • Not Korean ethnicity by family history
  • Inflammatory Bowel Disease Unclassified
  • Patients who already received colectomy due to ulcerative colitis

研究组 & 干预措施

Patients with confirmed ulcerative colitis

Patients with confirmed ulcerative colitis, who are going to receive vedolizumab therapy (n=100: development cohort n=70 and validation cohort n=30), ustekinumab therapy (n=100: development cohort n=70 and validation cohort n=30), or tofacitinib therapy (n=100: development cohort n=70 and validation cohort n=30), will be enrolled.

干预措施: Vedolizumab, Ustekinumab, or Tofacitinib (Drug)

结局指标

主要结局

Response to induction therapy

时间窗: Week 14 to Week 16

A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1

次要结局

  • Remission to induction therapy(Week 14 to Week 16)
  • Complete Mayo endoscopic subscore remission to induction therapy(Week 14 to Week 16)
  • Ulcerative colitis endoscopic index of severity remission to induction therapy(Week 14 to Week 16)
  • Response to maintenance therapy(Week 52)
  • Remission to maintenance therapy(Week 52)
  • Complete Mayo endoscopic subscore remission to maintenance therapy(Week 52)
  • Ulcerative colitis endoscopic index of severity remission to maintenance therapy(Week 52)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Byong Duk Ye

Professor

Asan Medical Center

研究点 (1)

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