NCT01088321已完成不适用
Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
Bristol-Myers Squibb0 个研究点目标入组 81,332 人开始时间: 2005年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81,332
- 主要终点
- Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
研究概览
简要总结
The purpose of this study is to compare the incidence rates of infection 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of rheumatoid arthritis
- •Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
- •Age 18 years or older at the time of drug initiation
- •Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation
排除标准
- •Below 18 years of age at the time of BDM or DMARD initiation
- •Lacking six months of continuous enrollment prior to the initiation of one of the study drugs
结局指标
主要结局
Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
时间窗: Every four months throughout the study
次要结局
- Anaphylactic reactions(Every four months throughout the study)
- Concomitant biologic use(Every four months throughout the study)
- Multiple sclerosis, lupus, and psoriasis(Every four months throughout the study)
研究者
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