NCT01759264已完成不适用
An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience
AbbVie (prior sponsor, Abbott)0 个研究点目标入组 101 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 主要终点
- Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
研究概览
简要总结
The objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's Disease who were treated with adalimumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's Disease participants were defined as:
- •Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) greater than 220, who started Adalimumab treatment in a normal clinical practice setting.
- •Fecal Calprotectin greater than or equal to 150 microgram/g.
- •Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.
排除标准
- •Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
- •Participants who had undergone colectomy other than ileocecal resection.
- •Pregnancy or breast feeding.
- •Contraindication to any anti-tumor necrosis factors (TNF) agent.
- •Any drug dependency.
结局指标
主要结局
Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram
时间窗: At Week 4
Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.
次要结局
- Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram(At Week 8 and 12)
- Mean Percent Change of Fecal Calprotectin From Baseline(Week 4, 8, and 12)
- Percentage of Participants With Remission of Crohn's Disease(At Week 4, 8, and 12)
- Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment(At Week 4, 8, and 12)
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