NCT01355614已完成2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation
研究概览
简要总结
This study will assess the safety and efficacy of QAX576 if patients with fistulizing Crohn's disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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-TNFα (tumour necrosis factor) antibody treatment)
- •Patients should not suffer from any other health problems that may jeopardize their participation in the study.
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-TNFα 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-TNFα antibody treatment
- •Intercurrent bacterial or viral (intestinal) infection (serologically or microbiologically confirmed)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QAX576
Experimental
干预措施: QAX576 (Drug)
Infliximab
Other
干预措施: Infliximab (Drug)
结局指标
主要结局
Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation
时间窗: 52 weeks
次要结局
- Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc(52 weeks)
研究者
研究点 (1)
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