A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 614
- 试验地点
- 177
- 主要终点
- Percentage of Participants With Remission at Week 8
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
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
- Quadruple (Participant, Care Provider, 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
- •Subject must be at least 18 years of age.
- •Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
- •Subjects with moderately to severely active UC based on Mayo score criteria.
- •Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- •Corticosteroids (oral or intravenous).
- •Azathioprine or 6 mercaptopurine (6 MP).
- •Anti TNF-alpha therapy.
排除标准
- •Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- •Subjects with disease limited to distal 15 cm.
- •Subjects without previous treatment for UC (ie, treatment naïve).
- •Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
研究组 & 干预措施
tofacitinib 10 mg BID
干预措施: tofacitinib (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Remission at Week 8
时间窗: Week 8
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 is 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 proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
次要结局
- Percentage of Participants Achieving Mucosal Healing at Week 8(Week 8)
- Percentage of Participants Achieving Clinical Response at Week 8(Week 8)
- Percentage of Participants With Endoscopic Remission at Week 8(Week 8)
- Percentage of Participants With Clinical Remission at Week 8(Week 8)
- Percentage of Participants With Symptomatic Remission at Week 8(Week 8)
- Percentage of Participants With Deep Remission at Week 8(Week 8)
- Partial Mayo Scores(Baseline, Weeks 2, 4, 8)
- Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8(Baseline, Weeks 2, 4, 8)
- Change From Baseline in Total Mayo Scores at Week 8(Baseline, Week 8)