NCT00736983已完成3 期
Adalimumab for the Treatment of Perianal Fistulas in Crohn's Disease More Effective Alone or Combined to Ciprofloxacin
Foundation for Liver Research13 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
研究概览
简要总结
To assess whether a combination of ciprofloxacin and adalimumab is more effective than adalimumab alone for the treatment of perianal fistulas in Crohn's disease
详细描述
Dutch multicenter, randomized, double-blind study with two arms. 146 patients will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •proven Crohn's disease
- •Single or multiple draining perianal fistulas
排除标准
- •Abscesses
- •Infliximab, cyclosporine, tacrolimus and antibiotics for Crohn's disease within past 3 months
- •active viral infection
- •significate cardiovascular dysfunction
- •Pregnancy, Lactation
- •Surgical bowel resection to be expected within 6 months
- •Positive stool culture for enteric pathogens
- •Total parental nutrition
研究组 & 干预措施
1
Active Comparator
Adalimumab
干预措施: adalimumab (Drug)
2
Placebo Comparator
ciprofloxacin
干预措施: ciprofloxacin (Drug)
结局指标
主要结局
Reduction of 50% or more from baseline to week 12 in the number of draining perianal fistulas.
时间窗: 12 week
次要结局
- Proportion of patients in remission(12 week)
研究者
研究点 (13)
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