NCT00206674已完成3 期
Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease
Genzyme, a Sanofi Company0 个研究点目标入组 286 人开始时间: 2004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
- 286
- 主要终点
- Induction of clinical response and/or remission as defined by decrease in CDAI score
研究概览
简要总结
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohn's disease.
详细描述
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
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
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
- •Stable but active Crohn's disease at the time of screening
- •Must be able to self-inject or have another person who can help with the injection
排除标准
- •Not have a colostomy or ileostomy
- •Not be taking prohibited medications as defined in the protocol
- •Not have had GI surgery or a bowel obstruction in the last 6 months or planned surgery for the next months
- •Not have ever taken this drug or drugs of similar type in the past
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sargramostim (Leukine) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Induction of clinical response and/or remission as defined by decrease in CDAI score
时间窗: After 8 weeks of treatment
次要结局
- Time and duration to response/remission(During the 8 weeks of treatment)
- QoL (different methods)(During the whole study)
- Safety Profile ( Adverse Event, Serious Adverse Event collection, laboratories especially AB test etc.)(About 20 months)
研究者
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