NCT01009281终止2 期
A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 5
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.
排除标准
- •Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- •Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study
- •Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457
Experimental
干预措施: AIN457 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From Start of the Study up to Study Termination (up to 42 Weeks)
次要结局
- Number of Participants With Anti-AIN457 Antibodies(From Start of the Study up to Study Termination (up to 42 Weeks))
- Change From Baseline in Concentration of Interleukin 17 (IL-17)(Baseline up to Study Termination (up to 42 Weeks))
- Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin(Baseline up to Study Termination (up to 42 Weeks))
- Change From Baseline in C-Reactive Protein Levels(Baseline up to Study Termination (up to 42 Weeks))
- Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss)(Pre-dose, post dose on week 44 (end of infusion))
- Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss)(Pre-dose, post dose on week 44 (end of infusion))
研究者
研究点 (5)
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