EUCTR2016-004572-21-DK进行中（未招募）1 期
Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 18 – 75 years at screening and randomisation
- •- Diagnosis of ulcerative colitis = 5 months prior to screening
- •- ReceivingTNFi treatment with doses unchanged for =4 months (infliximab) or = 2 months (adalimumab and golimumab) prior to randomisation
- •- Mild or moderate disease activity, defined as total Mayo Score (MCS) (=10)
- •- Further criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Prior use of more than two different TNF inhibitors or vedolizumab
- •- Extensive colonic resection
- •- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- •- Active or latent tuberculosis
- •- Further criteria apply
研究者
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