Post-marketing Study Assessing the Long-Term Safety of Abatacept
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100,000
- 主要终点
- Risk of Lung Cancer
研究概览
简要总结
The purpose of this study is to evaluate the risk of infections and malignancies among Rheumatoid Arthritis (RA) patients treated with Abatacept compared to other RA treatments.
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 has at least two claims for RA (714.xx) in the 180 days prior to and including the index date (baseline period)
- •Patient is aged 18 years or older on the index date
- •Patient was enrolled in the database for at least 180 days before the index date
- •Patient is newly prescribed Abatacept or another RA treatment and has at least two claims for the treatment
排除标准
- 未提供
研究组 & 干预措施
RA patients who are prescribed Abatacept
Abatacept
干预措施: Abatacept (Drug)
结局指标
主要结局
Risk of Lung Cancer
时间窗: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of lymphoma
时间窗: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of breast cancer
时间窗: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of non-melanoma skin cancer
时间窗: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of all malignancies
时间窗: Cancer: From 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of hospitalized infections
时间窗: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of pneumonia
时间窗: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of opportunistic infections
时间窗: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
Risk of tuberculosis
时间窗: Infection: From the index date until the first of the following: end of treatment +90 days, event of interest, death or end of study (approximately 1 year)
The index date is defined as the date that the patient initiates Abatacept or a comparison anti-rheumatic drug
次要结局
- Incidence of lupus(Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years))
- Incidence of multiple sclerosis(Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years))
- Incidence of psoriasis(Outcomes will be assessed from 180 days after the index date until the first of the following: event of interest, death, or end of study (approximately 2 years))