NCT01327664撤回3 期
A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
研究概览
简要总结
This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed
- •Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1)
- •Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator
排除标准
- •Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457
- •Pregnant or nursing (lactating) women
- •Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AIN457 300mg s.c every 2 weeks
Experimental
干预措施: AIN457 (Biological)
结局指标
主要结局
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
时间窗: up to 36 months
Participants with adverse events as a measure of safety and tolerability
时间窗: up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis
时间窗: up to 36 months
次要结局
- Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment(up to 36 months)
- Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457(up to 36 months)
- Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment(up to 36 months)
研究者
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