NCT00739960终止2 期
Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
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
- 1
- 试验地点
- 1
- 主要终点
- Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
研究概览
简要总结
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of sarcoidosis for at least 1 year with lung disease
- •Active disease despite current treatment
- •On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days
排除标准
- •Previous treatment with Abatacept
- •Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab)
- •Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide
- •Previous treatment of IVIg within the last 6 months
- •History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks
- •History of congestive heart failure
研究组 & 干预措施
Abatacept
Other
干预措施: Abatacept (Drug)
结局指标
主要结局
Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
时间窗: 24 weeks and 52 weeks
Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.
次要结局
- Change From Baseline in 6-minute Walk Distance.(24 weeks and 52 weeks)
研究者
研究点 (1)
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