EUCTR2016-004572-21-NO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
相似试验
进行中（未招募）
1 期
A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.Mild-to-moderately active ulcerative colitis on TNF inhibitor therapyMedDRA version: 19.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2016-004572-21-ESBoehringer Ingelheim España, S.A.39
已完成
2 期
Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapybowel inflammation10017969ulcerative colitisNL-OMON47670Boehringer Ingelheim6
进行中（未招募）
1 期
A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.Mild-to-moderately active ulcerative colitis on TNF inhibitor therapyMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856EUCTR2016-004572-21-GBBoehringer Ingelheim Limited30
进行中（未招募）
1 期
A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.EUCTR2016-004572-21-DKBoehringer Ingelheim Pharma GmbH & Co. KG30
进行中（未招募）
1 期
A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.Mild-to-moderately active ulcerative colitis on TNF inhibitor therapyMedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856EUCTR2016-004572-21-DEBoehringer Ingelheim Pharma GmbH & Co. KG30