Setting up a Pediatric Cohort for Inflammatory Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 15,000
- 试验地点
- 45
- 主要终点
- Number of treatments prescribed off label
研究概览
简要总结
The investigators created a cohort of patients with juvenile inflammatory rheumatisms with the purpose to follow them prospectively, and investigate the tolerance and efficacy of immunosuppresive and biological agents.
详细描述
The JIR-cohort has to be filled by an authorized investigator during or after the consultation. Each patient much be followed at least once a year.
Different data are requested in the JIR-cohort: diagnosis, treatment, adverse events and outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with juvenile inflammatory diseases
- •Age at onset up to 18 years old
- •Consent according national codes of ethics and current laws
排除标准
- •Non-consent from patients and/or legal representative
结局指标
主要结局
Number of treatments prescribed off label
时间窗: 10 Years
Length in months of drug survival in patient treated with at least two consecutive biological agents
时间窗: 10 Years
Number of severe and very severe adverse event as a mesure of safety and tolerability
时间窗: 10 years
次要结局
未报告次要终点
研究者
Michaël Hofer
Head of Pediatric Rheumatology unit
University of Lausanne Hospitals