NCT03257345Unknown不适用
VEST: The UK Vedolizumab Real Life Experience Study in Inflammatory Bowel Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 22
- 主要终点
- Steroid-free remission
研究概览
简要总结
Vedolizumab has been approved for the treatment of both ulcerative colitis and Crohn's disease. The aim of this study is to capture the early real life UK experience of vedolizumab including the outcomes of treatment, describing the patient population treated, drug persistence, IBD control PROM, durable remission, tolerance and safety.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants being given vedolizumab as part of routine care, and vedo naïve prior to study
- •Age 18 or over
- •Written informed consent obtained from patient for participation in the UK IBD Registry
排除标准
- •Patient unwilling to take part in the UK IBD Registry
- •Unable to obtain written informed consent
- •Patient is, in the opinion of the investigator, not suitable to participate in the study
- •Patients with contraindications to the use of vedolizumab
结局指标
主要结局
Steroid-free remission
时间窗: Week 56
Steroid-free remission at one year as defined by an HBI at week 56 of ≤4 or a UCDAI of ≤2
次要结局
- HES data(1 year)
- Remission and response(Multiple)
- Durable remission(Multiple)
- Effect of vedolizumab(TBC)
- Description of disease(TBC)
- Tolerance and safety(1 year)
研究者
Fraser Cummings
Consultant Gastroenterologist
University Hospital Southampton NHS Foundation Trust
研究点 (22)
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