Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
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
- 否
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
Byong Duk Ye
Professor
Asan Medical Center
