NCT01555879已完成不适用
Abatacept in T3: A Characterization of Abatacept's Efficacy and Outcomes From a Real-Word Clinical Practice Information Hub on Novel Patient Sub-Groups
Arthritis Northwest PLLC1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年3月最近更新:
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
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
研究概览
简要总结
The purpose of this study is to assess the effectiveness of Abatacept in real-world clinical practice. The main hypothesis to be examined in this study is, "Abatacept's effectiveness results in a single real-world clinic (n = 100) are reproducible at another site (n ~= 200)".
详细描述
Two secondary hypotheses that will be tested are:
- Abatacept aids in achieving low disease activity or clinical remission in patients of the following Rheumatoid Arthritis (RA) sub-groups: RF+/CCP+, RF+/CCP- RF-/CCP+ RF-/CCP-; first time on a bio-tech drug; having previously failed a biological drug; having interstitial lung disease; identified as disabled; twenty-eight individual joints identified as {swollen, painful, tender, deformed or having decreased range of motion}; on or not on oral DMARD; age; or gender.
- A database with sufficient attributes exists from which a patient's efficacy on abatacept is accurately predictable.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rheumatoid arthritis
- •Have used Abatacept for 3 or more months
排除标准
- 未提供
研究组 & 干预措施
All patients
All patients in T3 who have used Abatacept for at least 3 months between 2009-03-17 and 2011-11-30.
干预措施: Abatacept (Drug)
结局指标
主要结局
Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.
时间窗: Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 6 months.
次要结局
- Determine the efficacy of abatacept by analyzing the change in CDAI, DAS28, and RAPID3 scores.(Change from baseline in CDAI, DAS28, and RAPID3 scores at approximately 9 months.)
研究者
研究点 (1)
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