NCT01088360进行中（未招募）不适用
An Observational Cohort to Assess Safety and Outcomes in Patients Treated With Abatacept and Other Anti-Rheumatic Therapies
Bristol-Myers Squibb0 个研究点目标入组 20,000 人开始时间: 2005年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20,000
- 主要终点
- Key safety outcomes (targeted infections, malignancies, mortality)
研究概览
简要总结
The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.
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
- •Signed informed consent
- •Diagnosis of rheumatoid arthritis
- •> 18 years at index treatment initiation or switch
- •Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
- •Read/write English
排除标准
- 未提供
结局指标
主要结局
Key safety outcomes (targeted infections, malignancies, mortality)
时间窗: Every 6 months throughout the study
次要结局
- Adverse events in subjects on abatacept who receive concomitant biologics(Every 6 months throughout the study)
- Patient-reported infusion reactions(Every 6 months throughout the study)
- Multiple sclerosis, lupus, and psoriasis(Every 6 months throughout the study)
- Adverse events in pregnant women who receive abatacept(Every 6 months throughout the study)
研究者
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