NCT02739386已完成不适用
Evaluation of Hospitalization for Complications of Autoimmune Disease Following Ipilimumab Treatment Among Melanoma Patients With Underlying Autoimmune Diseases Treated in Routine Clinical Practices in the US
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2016年2月29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
- 370
- 试验地点
- 1
- 主要终点
- Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
研究概览
简要总结
The research questions to be addressed by this study are as follows:
- What is the prevalence of ipilimumab use among adults with a history of autoimmune disease that received treatment with ipilimumab for advanced melanoma?
- Do melanoma patients with a history of autoimmune disease experience complications that require hospitalization related to their underlying autoimmune disease following treatment with ipilimumab?
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
- •Received ipilimumab therapy between 03/01/2011 and 6/30/2014
- •Aged 18 years or older at index date (initiation of ipilimumab)
- •Diagnosed with melanoma before index
- •Documented history of an autoimmune disease
- •Have at least 6 months of continuous pharmaceutical and medical benefit enrollment prior to the index
- •Have at least 3 months of continuous pharmaceutical and medical benefit enrollment following and including the index date
排除标准
- •Diagnosed with melanoma but NO record of exposure to ipilimumab
- •No exposure to nivolumab (Opdivo ®) at any time
结局指标
主要结局
Incidence of ipilimumab treatment among adult melanoma patients with a prior or existing autoimmune disease/condition
时间窗: Approximately 40 months
Incidence of hospitalizations related to the pre-existing autoimmune disease/condition following treatment with ipilimumab
时间窗: Approximately 40 months
次要结局
- Incidence rate of hospitalization related to a complication of the underlying autoimmune condition after exposure to ipilimumab treatment(Approximately 40 months)
- Incidence rate of hospitalization related to a complication of the underlying autoimmune condition before exposure to ipilimumab treatment(Approximately 40 months)
研究者
研究点 (1)
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