A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.
详细描述
This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.
Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's disease of at least 3 months duration confirmed by radiography orendoscopy
- •Having single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration
- •If treated with oral prednisone (or equivalent), the dose must be <=40 mg/day and must have been stable for at least 3 weeks prior to enrollment. (If currently not treated with oral prednisone, the stop date must have been at least 4 weeks prior to enrollment)
- •If treated with 6-mercaptopurine or azathioprine, the start date must have been at least 6 months prior to enrollment. (The dose must have been stable for at least 8 weeks prior to enrollment. If currently not treated with 6-mercaptopurine or azathioprine, the stop date must have been at least 4 weeks prior to enrollment.)
排除标准
- •Patients with local complications of Crohn's disease such as strictures or abscesses that might confound the evaluations of the benefit from cA2 treatment
- •Having abscesses that should be drained prior to enrollment, with at least 3 weeks between drainage of the abscess and enrollment
- •Having a serious infection, such as hepatitis, pneumonia or pyelonephritis, in the previous 3 months or a history of opportunistic infection such as herpes zoster within 2 months prior to screening, or evidence of active cytomegalovirus, active pneumocystis carinii, or drug resistant atypical mycobacterium
- •Currently having signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- •Currently having any known malignancy or any history of malignancy within the past 5 years
研究组 & 干预措施
Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
干预措施: Infliximab 10 mg/kg (Drug)
Infliximab 5 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
干预措施: Infliximab 5 mg/kg (Drug)
Placebo
Matching placebo will be administered at Week 0, 2 and 6.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients with 50% or more reduction from baseline in the number of open fistulae at Week 3
时间窗: Week 3
Number patients with 50% or more reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits that is not accompanied by initiation of a therapeutic agent or increase in dose.
次要结局
- Percentage of patients achieving a complete response at week 52(Week 52)