NCT05421442已完成不适用
A Nationwide Post-marketing Study on the Safety of Abatacept Treatment in Denmark Using the DANBIO Register
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 38,396 人开始时间: 2019年6月13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
- 38,396
- 试验地点
- 1
- 主要终点
- Incidence Rates of Squamous Cell Carcinoma
研究概览
简要总结
The purpose of this study is to expand on the ongoing post-marketing monitoring of abatacept to include all participants with rheumatoid arthritis (RA) and psoriatic arthritis (PsA) treated with abatacept captured in Danish Database for Biologic Therapies (DANBIO).
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
- •Diagnosis of rheumatoid arthritis (RA) or psoriatic arthritis (PsA)
- •Receiving treatment with abatacept
- •Receiving treatment with non-targeted DMARD
- •Receiving treatment with targeted DMARD
排除标准
- •Not applicable
结局指标
主要结局
Incidence Rates of Squamous Cell Carcinoma
时间窗: Up to 5 years
Incidence Rates of Non-melanoma Skin Cancer
时间窗: Up to 5 years
Incidence Rates of Overall Malignancies
时间窗: Up to 5 years
Incidence Rates of Basal Cell Carcinoma
时间窗: Up to 5 years
Incidence Rates of Melanoma
时间窗: Up to 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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