Skip to main content
OpenTrials
Completed

NCT Number: NCT02880527

Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polymyositis Connective Tissue Diseases Dermatomyositis Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Patients with polymyositis / dermatomyositis

Other

recruitment of patients with polymyositis / dermatomyositis using :

  • medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
  • general practitioners
  • the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )
  • Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association

Primary outcomes

  1. Confirmed diagnosis of polymyositis / dermatomyositis

    Time frame: approximately 1 month

    recruitment of patients with polymyositis / dermatomyositis

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EPIDEMYOSITIS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.