NCT03839680Unknown不适用
Measuring Endoscopic ACTIvity in Patients Treated With VEDOlizumab for Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1
研究概览
简要总结
Describe the proportion of patients with ulcerative colitis (UC) treated with vedolizumab (VDZ) who achieve mucosal healing at week 54 of treatment.
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
- •age over 18 years,
- •established diagnosis of ulcerative colitis for at least 3 months
- •moderate to severe active ulcerative colitis with a Mayo endoscopic sub-score ≥ 1 before vedolizumab introduction
- •patients receiving vedolizumab according to French drug labelling (previous exposure to anti-TNF, contraindicated or intolerant to anti-TNF),
- •possibility of concomitant therapy including corticosteroids and immunosuppressors,
- •patients naive to anti-integrin,
- •no contraindication to proctosigmoidoscopy
排除标准
- •age under 18 years
- •ulcerative colitis not proven, Crohn's disease, or inderterminate colitis
- •personal history of high-grade dysplasia or colorectal cancer
- •surgery with ileo-anal anastomosis
- •patients' refusal to participate in the study
结局指标
主要结局
Mucosal healing at defined by Mayo endoscopic sub-score ≤ 1 or UCEIS ≤ 1
时间窗: 54 weeks
次要结局
- Mucosal healing at defined by Mayo endoscopic sub-score 0 or UCEIS 0(54 weeks)
- Endoscopic pattern of mucosal healing(54 weeks)
研究者
研究点 (4)
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