跳至主要内容
临床试验/NCT02694588
NCT02694588已完成不适用

Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Mucosal healing week 2

研究概览

简要总结

Inflammatory bowel disease (IBD) and psoriasis (Ps) are common, chronic, immune- mediated barrier diseases with shared inflammatory pathways. Current therapeutic interventions with anti-cytokine antibodies (TNF-α, IL-23/IL-12) reflect the intent to disrupt specific pathways of inflammatory immunopathology. Individual responses to biological treatment can be thereby be exploited in a systems biology approach that employs a targeted mechanism of action (MOA) to decipher molecular signatures of therapeutic responses in the context of a distinct disease entity. Using a translational approach to investigate clinical and molecular phenotypes during therapeutic interference with cytokine signaling and leukocyte trafficking, the investigators aim to trace common and unique signatures of drug- and therapy-specific responses.

Patients will undergo endoscopic evaluation of the mucosal surface and gastrointestinal wall by conventional HD-colonoscopy, endoscopic ultrasound and confocal laser endomicroscopy prior to and during specific therapies with biologicals. In parallel, mucosa samples will be obtained to define molecular phenotypes during the course of therapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • inflammatory bowel disease
  • indication for biological therapy

排除标准

  • pregnancy, breast feeding
  • no written informed consent to participate in the study

研究组 & 干预措施

Infliximab

Active Comparator

5 mg/kg body weight, week 0/2/6, then every 8 weeks

干预措施: Infliximab (Drug)

Vedolizumab

Active Comparator

300 mg, week 0/2/6, then every 8 weeks

干预措施: Vedolizumab (Drug)

结局指标

主要结局

Mucosal healing week 2

时间窗: week 2

Scoring of mucosal healing according to endoscopic Mayo score at week 2 after initiation of therapy

次要结局

未报告次要终点

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Ellrichmann

Head of Interdisciplinary Endoscopy

University Hospital Schleswig-Holstein

研究点 (1)

Loading locations...

相似试验

Clinical and Molecular Phenotyping in IBD | 临床试验