NCT02693340Unknown不适用
Evolution of Lymphocyte Populations Under Biotherapy in Inflammatory Bowel Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response to biological treatments
研究概览
简要总结
This is a monocentric prospective study for the collection of biological samples (blood and biopsies) to be used for in vitro biomarker assay(s) performed to identify predictive markers of response to biological treatments in inflammatory bowel disease (IBD).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or more.
- •Crohn's Disease Diagnosis (CD) or ulcerative colitis (UC) according to defined criteria (ECCO recommendations).
- •Active disease as defined by clinical biological and/or morphological assessment.
- •Initiation of an anti-Tumor Necrosis Factor (TNF) therapy (Infliximab, Adalimumab, Golimumab) or new biotherapy (Vedolizumab, Ustekinumab) provided in connection with the management of digestive disease.
- •Patient (e) have signed and dated consent of the study before undertaking procedures related to the study.
排除标准
- •Patients under guardianship / curators
- •Following Situations
- •Persons unable to understand, read and / or sign an informed consent
- •Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
- •Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
- •No affiliation to a social security scheme, a universal medical coverage or any similar plan.
- •Pregnant or lactating women.
结局指标
主要结局
Response to biological treatments
时间窗: 12 months
次要结局
- Microbiota variation(12 months)
研究者
研究点 (1)
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