NCT01247766已完成不适用
Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia
Bristol-Myers Squibb0 个研究点目标入组 6,367 人开始时间: 2010年12月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,367
- 主要终点
- Serious infection
研究概览
简要总结
The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.
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
- •Rheumatoid arthritis
- •Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
- •Age 18 years or older
排除标准
- •Below 18 years of age
结局指标
主要结局
Serious infection
时间窗: Every 2 years throughout the study
Incidence rates of malignancy
时间窗: Every 2 years throughout the study
(total, lymphoma, lung cancer, breast cancer, colorectal cancer)
Total mortality
时间窗: Every 2 years throughout the study
次要结局
- Multiple sclerosis(Every 2 years throughout the study)
研究者
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