EUCTR2010-019973-13-DE进行中（未招募）不适用
A multi-center, randomized, double-blind, active controlled study to assess efficacy, safety and tolerability of the anti-IL13 monoclonal antibody QAX576 in the treatment of perianal fistulas in patients suffering from Crohn’s disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At least one draining enterocutaneous perianal fistula
- •Diagnosis of Crohn's disease (CD) must have been established for at
- •least 6 months
- •At least one ineffective fistula treatment (but no previously failed anti-
- •TNFa (tumour necrosis factor) antibody treatment)
- •Patients should not suffer from any other health problems that may
- •jeopardize their participation in the study.
- •Additional details and inclusion criteria are available in the clinical study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current or recent (within 30 days of enrollment, or 5 half-lives of the
- •compound, whichever is longer) use of anti-TNFa antibody treatment
- •Active Crohn's disease
- •Recent or pending abdominal or ano-rectal surgery, particularly
- •presence of stricture, or abscess, or retention for which surgery might be indicated
- •Previously failed anti-TNFa antibody treatment
- •Intercurrent bacterial or viral (intestinal) infection (serologically or
- •microbiologically confirmed)
- •Additional details and exclusion criteria are available in the clinical study
研究者
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