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Epidemiological Study of Inflammatory Myopathies in a French Region (PREMIA)

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ClinicalTrials.gov Identifier: NCT02881450
Recruitment Status : Completed
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
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.

Condition or disease
Polymyositis

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Inflammatory Myopathies in Alsace
Study Start Date : January 2012
Actual Primary Completion Date : December 2013





Primary Outcome Measures :
  1. Estimate the prevalence of idiopathic inflammatory myopathies in Alsace. [ Time Frame: Prevalence of idiopathic inflammatory myopathies in Alsace at 1st January 2012 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Resident of Alsace region located in North-east France
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881450


Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jean SIBILIA, MD University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02881450     History of Changes
Other Study ID Numbers: 4963
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: December 2013

Additional relevant MeSH terms:
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases