A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy 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
- 180
- 试验地点
- 91
- 主要终点
- Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
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 who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A
- •Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A
- •Women of childbearing potential must test negative for pregnancy prior to study enrolment.
排除标准
- •Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
- •Subjects likely to require any type of surgery during the study period.
- •Fecal culture/toxin assay indicating presence of pathogenic infection.
研究组 & 干预措施
10mg BID
干预措施: CP-690,550 (Drug)
Placebo BID
干预措施: Placebo (Drug)
5mg BID
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
时间窗: Week 26
Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score \<150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.
次要结局
- Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase(Weeks 20 and 26)
- CDAI Score by Week(Baseline and Weeks 4, 8, 12, 20 and 26)
- Change From Baseline in CDAI Score by Week(Weeks 4, 8, 12, 20 and 26)
- Kaplan-Meier Estimate of the Rate of Time to Relapse(Weeks 4, 8 12, 20 and 26)
- Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline(Week 26)
- C-Reactive Protein (CRP) by Week(Baseline and Weeks 4, 8, 12, 20 and 26)
- Change From Baseline in CRP by Week(Weeks 4, 8, 12, 20 and 26)
- Fecal Calprotectin by Week(Baseline and Weeks 8, 12 and 26)
- Change From Baseline in Fecal Calprotectin by Week(Weeks 8, 12 and 26)
- Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose(Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit)
- Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20(Weeks 4, 8, 12 and 20)
- Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26(Weeks 4, 8, 12, 20 and 26)
- Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26(Weeks 4, 8, 12, 20 and 26)
- Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study(Weeks 4, 8, 12, 20 and 26)
- Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase(Weeks 20 and 26)