A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Clinical Response
研究概览
简要总结
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
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
- •Patients must be at least 18 years of age at screening
- •Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
- •Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
- •Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.
排除标准
- •Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
- •Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
- •Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
研究组 & 干预措施
Placebo
干预措施: placebo (Other)
3 mg BID
干预措施: CP- 690 550 (Drug)
10 mg BID
干预措施: CP- 690 550 (Drug)
15 mg BID
干预措施: CP- 690 550 (Drug)
0.5 mg BID
干预措施: CP- 690 550 (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Response
时间窗: Week 8
Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).
次要结局
- Percentage of Participants With Clinical Remission(Week 8)
- Percentage of Participants With Endoscopic Response(Week 8)
- Percentage of Participants With Endoscopic Remission(Week 8)
- Change From Baseline in Partial Mayo Score at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, 12)
- Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8(Baseline, Week 8)
- Change From Baseline in Level of C-Reactive Protein (CRP) at Week 4 and 8(Baseline, Week 4, 8)
- Change From Baseline in Level of Fecal Calprotectin at Week 2, 4, 8 and 12(Baseline, Week 2, 4, 8, 12)
- Plasma Concentration of CP-690,550(0.25, 0.5, 1, 2 hours post-dose on Day 1, 0 (pre-dose) and 1 hour post-dose on Week 2, Week 4, 0 (pre-dose), 0.25, 0.5, 1, 2 hours post-dose on Week 8)