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Completed

NCT Number: NCT02881450

Epidemiological Study of Inflammatory Myopathies in a French Region

Knowledge of the descriptive epidemiology of MIs is very limited. The main objective of this study is to determine the prevalence of inflammatory myopathies in Alsace at the 1st January 2012 with "capture-recapture" design using several independent sources of case identification.

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Key information

About this study

Inflammatory myopathies (MIs) are a group of muscle diseases with a significant heterogeneity, clinical, immunological and prognosis.

The old classifications, still currently used, highlight this heterogeneity. Therefore Troyanov and coll. and Hoogendijk and coll. have each recently proposed a classification based on clinical and serological - and immuno- histological examination.

The pathogenesis and prognosis of MIs is very different depending on the entity in question.

Knowledge of the descriptive epidemiology of MIs is very limited. In fact no epidemiological work using criteria consensual classification is actually started.

We propose an epidemiological study of MIs. The main objective of the study is to determine the prevalence of MIs in Alsace at 1stJanuary 2012 by means of a "capture- recapture" study using several independent sources of case identification. The secondary objectives of the study are:

  • estimating the geographical distribution of the disease in the Alsace region and / or Auvergne
  • demographic description of patients : age, sex, residence , occupation
  • description of the disease: patient age at diagnosis, disease classification , main clinical manifestations and complications
  • Identification of paraneoplastic forms will be for the Alsace region by crossing with Alsatian cancer registries. These records will be interviewed to identify cases of MIs associated with cancers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patient reported suffering from inflammatory myopathy
  • Meeting the Hoogendijk, Troyanov and Griggs classification criteria
  • Alive at 1st January 2012- Domiciled in Alsace (Bas-Rhin or Haut-Rhin counties of France)

Exclusion criteria

  • All patient reported with a different or incomplete diagnosis of inflammatory myopathy (not meeting the Hoogendijk, Troyanov and Griggs criteria)
  • All patient dead and/or non-domiciled in Alsace at 1st January 2012

Treatment and study plan

Primary outcomes

  1. Estimate the prevalence of idiopathic inflammatory myopathies in Alsace.

    Time frame: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Prevalence of Inflammatory Myopathies in Alsace

Acronym: PREMIA

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2016
Registry last updated
Aug 20, 2019

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.

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