NCT02790281已完成不适用
A Study to Investigate Interleukin-6 (IL-6) and IL-6/Soluble IL-6 Receptor (sIL-6R) Complex Levels in Subjects With Active Inflammatory Bowel Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Exploratory: Levels of IL-6
研究概览
简要总结
The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with active moderate to severe ulcerative colitis (*partial Mayo ≥ 5) or Crohn's disease (Harvey & Bradshaw ≥ 8) *partial Mayo: 9-point scale that excludes the endoscopic components of the Mayo score
排除标准
- •Presence of another inflammatory disease, except for mild cutaneous psoriasis
- •Concomitant gastrointestinal infection or otherwise serious infection including Crohn's disease infectious complication
- •Treatment with Infliximab, Adalimumab, Certolizumab Pegol or other immune-modulating biologics within 8 weeks prior to the visit
- •Having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit
- •Concomitant diagnosed or suspected malignant disease
结局指标
主要结局
Exploratory: Levels of IL-6
时间窗: At Day 1
Blood sample was taken for analysis of levels of IL-6.
Exploratory: Levels of C-reactive Protein (CRP)
时间窗: At Day 1
Blood sample was taken for analysis of levels of CRP.
Exploratory: Levels of IL-6/sIL-6R Complex
时间窗: At Day 1
Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.
次要结局
未报告次要终点
研究者
研究点 (2)
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