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临床试验/NCT02880527
NCT02880527已完成不适用

Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
187
试验地点
1
主要终点
Confirmed diagnosis of polymyositis / dermatomyositis

研究概览

简要总结

Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor of morbidity and mortality in these patients. At present, studies that evaluated the prevalence of polymyositis / dermatomyositis are very few; they were mainly recorded in the United States and Japan, the prevalence of polymyositis / dermatomyositis has been estimated between 3.5 and 21.5 cases / 100 000 (according to the old diagnostic criteria of Bohan and Peter). However, previous works are old and retrospective; above all, they have almost always been performed (90% of cases) from cases reported to the hospital, leading to selection bias and an underestimate of the true prevalence of polymyositis / dermatomyositis in the general population.

Thus, these data lead to achieve this epidemiological study, descriptive, multicenter, based on the population of Normandy.

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

入选标准

  • patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
  • patient living Normandy ;
  • patient has been informed and has given its verbal agreement ;

排除标准

  • patients with myositis diagnosed before inclusion (including pathophysiology, clinical phenotype and therapeutic care are different from polymyositis / dermatomyositis)

结局指标

主要结局

Confirmed diagnosis of polymyositis / dermatomyositis

时间窗: approximately 1 month

recruitment of patients with polymyositis / dermatomyositis

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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