NCT03696173已完成不适用
Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 5,800 人开始时间: 2015年12月17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
- 5,800
- 试验地点
- 1
- 主要终点
- Incidence of increased risk of serious infection while taking abatacept
研究概览
简要总结
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date
- •Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date
- •Patient is aged 18 years or older on the entry date
- •Patient was enrolled in the database for at least 180 days before the entry date
排除标准
- •Patient is younger than 18 years on the entry date
- •Patients who receive abatacept and another biologic simultaneously
- •Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Incidence of increased risk of serious infection while taking abatacept
时间窗: Approximately 7 years
Without methotrexate
Incidence of malignancy while taking abatacept
时间窗: Approximately 7 years
Without methotrexate
次要结局
未报告次要终点
研究者
研究点 (1)
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