NCT01279954已完成2 期
An Openlabel, Phase II Trial of Abatacept (Orencia) in the Treatment of Refractory Non-infectious Uveitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of abatacept in the treatment of uveitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with vision-threatening autoimmune uveitis
- •failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
排除标准
- •serious concomitant illness that could interfere with the subject's participation
研究组 & 干预措施
open-label abatacept first, then 5 mg/kg abatacept
Experimental
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
干预措施: Abatacept (Drug)
open-label abatacept first, then 10 mg/kg abatacept
Experimental
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
干预措施: Abatacept (Drug)
结局指标
主要结局
Adverse Events
时间窗: 2 years
number of participants with adverse events
次要结局
- Number of Participants With Improvement by 2 or More Lines of Best-corrected Visual Acuity(Week 24)
- Number of Participants With Reduction in Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%(Week 24)
- Number of Participants With Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods(Week 24)
研究者
Eric B. Suhler
Associate Professor
Oregon Health and Science University
研究点 (1)
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