ACTRN12622001458729招募中3 期
Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease: a randomised controlled trial - DISCUS-IBD
The Alfred Hospital0 个研究点目标入组 120 人开始时间: 2022年11月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Adult luminal CD or UC patients on maintenance escalated IV infliximab in clinical steroid-free remission for at least 6 months and biochemical remission at study entry, defined as:
- •- Modified HBI <5 for CD and partial Mayo score <2 for UC) AND
- •- CRP <5 mg/L AND FCP <250 µg/g
排除标准
- •- Patients with recent IV infliximab dose change (within 3 months)
- •- Patients with perianal CD in the absence of luminal CD
- •- Pregnancy or planning pregnancy within 12 months
- •- Actively breastfeeding
- •- Weight <40 kg or >120 kg
研究者
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