Systematic Profiling of Anti-inflammatory Drugs for the Detection of Drug- Specific Response Signatures in the Treatment of Chronic Inflammatory Disorders
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
- 否
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
5 mg/kg body weight, week 0/2/6, then every 8 weeks
干预措施: Infliximab (Drug)
Vedolizumab
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
Mark Ellrichmann
Head of Interdisciplinary Endoscopy
University Hospital Schleswig-Holstein
