A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 593
- 试验地点
- 271
- 主要终点
- Percentage of Participants In Remission at Week 52
研究概览
简要总结
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
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
- •Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
- •Subjects who achieved clinical response in Study A3921094 or A3921095
- •Women of childbearing potential must test negative for pregnancy prior to study enrollment
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
- •Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
研究组 & 干预措施
Placebo Comparator
干预措施: Placebo (Drug)
CP-690,550 5 mg Arm
干预措施: CP690,550 (Drug)
CP-690,550 10 mg Arm
干预措施: CP-690,550 (Drug)
结局指标
主要结局
Percentage of Participants In Remission at Week 52
时间窗: Week 52
Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
次要结局
- Percentage of Participants With Mucosal Healing at Week 24(Week 24)
- Percentage of Participants With Sustained Mucosal Healing(Week 24, 52)
- Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline(Week 24, 52)
- Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline(Week 24, 52)
- Percentage of Participants With Clinical Response at Week 24 and 52(Week 24, 52)
- Percentage of Participants With Sustained Clinical Response(Week 24, 52)
- Percentage of Participants in Clinical Remission at Week 24 and 52(Week 24, 52)
- Percentage of Participants in Sustained Clinical Remission(Week 24, 52)
- Percentage of Participants With Mucosal Healing at Week 52(Week 52)
- Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline(Week 24, 52)
- Percentage of Participants in Remission at Week 24(Week 24)
- Percentage of Participants in Sustained Remission(Week 24, 52)
- Percentage of Participants in Deep Remission at Week 24 and 52(Week 24, 52)
- Percentage of Participants in Sustained Deep Remission(Week 24, 52)
- Percentage of Participants in Symptomatic Remission at Week 24 and 52(Week 24, 52)
- Percentage of Participants in Sustained Symptomatic Remission(Week 24, 52)
- Percentage of Participants in Endoscopic Remission at Week 24 and 52(Week 24, 52)
- Percentage of Participants in Sustained Endoscopic Remission(Week 24, 52)
- Total Mayo Score at Baseline, Week 24 and 52(Baseline, Week 24, 52)
- Change From Baseline in Total Mayo Score at Week 24 and 52(Baseline, Week 24, 52)
- Percentage of Participants in Remission, Among Participants With Remission at Baseline(Week 24, 52)
- Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline(Week 24, 52)
- Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline(Week 24, 52)
- Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline(Week 24, 52)
- Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline(Week 24, 52)