2024-514740-82-00尚未招募4 期
Subcutaneous vedolizumab drug de-escalation in inflammatory bowel disease: a multicentre randomised controlled study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 278
- 试验地点
- 7
- 主要终点
- Difference in relapse rate
研究概览
简要总结
Evaluating the effectiveness of subcutaneous vedolizumab dose de-escalation
研究设计
- 分配方式
- Randomized
- 主要目的
- Full trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adults diagnosed with Crohn's Disease or Ulcerative Colitis in steroïd-free clinical and biochemical remission treated with bi-weekly subcutaneous vedolizumab for six or more months
排除标准
- •Use of corticosteroïds, active fistula or need for IBD-related surgery
结局指标
主要结局
Difference in relapse rate
Difference in relapse rate
次要结局
- Factors associated with successful interval extension
- Proportion of patients having needed corticosteroïd treatment during follow-up
- Differences in emergency visits, hospitalizations and surgery
- Difference in quality of life
- Cost-effectiveness of interval extension
- Differences in adverse events
- Vedolizumab pharmacodynamics and pharmacokinetics
研究者
IBD trial bureau
Scientific
Stichting Amsterdam UMC
研究点 (7)
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