NCT05544292已完成不适用
Rheumatic IMmune-Related Adverse Events in Patients Treated With Immune Check Point Inhibitors - a Prospective Observational Study
Diakonhjemmet Hospital5 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2018年3月5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
- 69
- 试验地点
- 5
- 主要终点
- Swollen joint count
研究概览
简要总结
RIMRA is a prospective, longitudinal, observational study including patients with de novo symptoms of rheumatic disease or a flare of established rheumatic disease after treatment with an immune check point inhibitor. The aim of the study is to describe the clinical presentation, disease course and outcome of rheumatic irAEs in patients treated with immune check point inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •De novo symptoms of rheumatic disease or a flare of established rheumatic disease after >/= 1 dose of treatment with an immune check point inhibitor
- •Adult patients (> 18 years)
- •Subject capable of understanding and signing an informed consent form
排除标准
- •Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
结局指标
主要结局
Swollen joint count
时间窗: 1 year follow-up
Numbers (0-66)
次要结局
- C reactive protein(1 year)
- Proportion of pateints with arthritis after one year(1 year)
研究者
研究点 (5)
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