Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Mucosal healing
研究概览
简要总结
Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).
Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.
In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients with IBD:
- •Patients with IBD treated with approved biologics
- •Age 18 or over
- •Written informed consent obtained from patient for participation
- •For non-IBD healthy volunteers:
- •Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study
- •Age 18 or over
- •Written informed consent obtained from patient for participation
排除标准
- •Unable to obtain written informed consent
- •Patient is, in the opinion of the investigator, not suitable to participate in the study
研究组 & 干预措施
CD group
A group in which patients are diagnosed as crohn's disease
干预措施: Biologics (Drug)
UC group
A group in which patients are diagnosed as ulcerative colitis
干预措施: Biologics (Drug)
结局指标
主要结局
Mucosal healing
时间窗: At week 42-64
Mucosal healing is defined as absence of mucosal ulceration
Clinical response
时间窗: At week 14-26
The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI \<150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis
次要结局
- Clinical response rate with steroids or without steroids(At week 14-26 and week 42-64)
- EQ-5D score(At baseline, week 14-26 and week 42-64)
- Clinical remission rate with steroids or without steroids(At week 14-26 and week 42-64)
- Objective response rate(At week 14-26 and week 42-64)
- 36-Item Short Form Health Survey (SF-36) score(At baseline, week 14-26 and week 42-64)
- Incidence of adverse events(Through study completion)
- Inflammatory Bowel Disease Questionnaire (IBDQ) score(At baseline, week 14-26 and week 42-64)
- Objective remission rate(At week 14-26 and week 42-64)
研究者
Xiang Gao
Director
Sixth Affiliated Hospital, Sun Yat-sen University