A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 265
- 试验地点
- 137
- 主要终点
- Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
研究概览
简要总结
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
- •hsCRP greater than 3mg/L
- •Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening
排除标准
- •Pregnant or breast feeding
- •Short bowel syndrome due to multiple small bowel resections
- •Presence of a stoma
研究组 & 干预措施
Drug Dose level 1- SC injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
干预措施: PF-00547659 SC injection (Drug)
Placebo-SC Injection
Placebo delivered SC, 3 doses separated by 4 weeks.
干预措施: PF-00547659 SC injection (Drug)
Drug Dose level 2-SC injection
Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
干预措施: PF-00547659 SC injection (Drug)
Drug Dose level 3- SC injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
干预措施: PF-00547659 SC injection (Drug)
结局指标
主要结局
Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate
时间窗: Week 8 and week 12
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
次要结局
- Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo(Week 0-12)
- The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)(Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)
- Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo(Week 0-12)
- Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission(Weeks 8 and week 12)
- The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)(Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)
- Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time(Week 2, 4, 6, 8, 10 and 12)
- Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer(Week 2, 4, 6, 8, 10 and 12)
- The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)(Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)
- Immunogenicity Assessment of Anti-drug Antibodies (ADAs)(Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36)
- The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)(Day 1, 14, and 28)
- The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)(Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)
- The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)(Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252)