A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response 70 at Week 4
研究概览
简要总结
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Subjects must be at least 18 years of age at screening
- •Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
- •Subjects with moderate to severe Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
排除标准
- •Subjects currently receiving immunosuppressants, interferon, anti-TNFa
- •Subjects with evidence of hematopoietic disorders
- •Subjects with evidence of active or latent TB
研究组 & 干预措施
1mg BD
干预措施: CP-690,550 (Drug)
Placebo BID
干预措施: Placebo (Drug)
5mg BD
干预措施: CP-690,550 (Drug)
15mg BD
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Number of Participants With Clinical Response 70 at Week 4
时间窗: Week 4
Clinical response 70: defined as a reduction in Crohn's Disease Activity Index (CDAI) score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
次要结局
- Number of Participants With Clinical Response 70 at Week 1 and 2(Week 1, 2)
- Number of Participants Achieving Clinical Remission at Week 4(Week 4)
- Number of Participants With Clinical Response 100 at Week 4(Week 4)
- Time to First Clinical Remission(Week 1 through Week 4)
- Time to First Response 70(Week 1 through Week 4)
- Time to First Response 100(Week 1 through Week 4)