NCT01339481已完成不适用
A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- CD86 Receptor Occupancy
研究概览
简要总结
The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label
- •Subject is willing and able to comply with study visits and procedures
排除标准
- 未提供
研究组 & 干预措施
Subjects with RA initiating abatacept treatment regimen
Subjects naïve to both abatacept and belatacept
干预措施: abatacept (Drug)
结局指标
主要结局
CD86 Receptor Occupancy
时间窗: Day 1, Weeks 2, 4, 8, and 12
次要结局
- Abatacept serum concentration(Day 1, Weeks 2, 4, 8 and 12)
- Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis(Day 1 and Week 12)
- CD80 Receptor Occupancy(Day 1, Weeks 2, 4, 8, and 12)
- Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis(Day 1 and Week 12)
- Safety assessed by adverse event reporting including Physical Examination findings(Day 1 through Week 12 post-infusion)
研究者
研究点 (7)
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