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Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy (EPIDEMYOSITIS)

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ClinicalTrials.gov Identifier: NCT02880527
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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.


Condition or disease Intervention/treatment
Polymyositis Dermatomyositis Other: Patients with polymyositis / dermatomyositis

Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016


Group/Cohort Intervention/treatment
patients with polymyositis / dermatomyositis

recruitment of patients with polymyositis / dermatomyositis will be used:

  1. medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
  2. general practitioners
  3. the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )

5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association

Other: Patients with polymyositis / dermatomyositis

recruitment of patients with polymyositis / dermatomyositis using :

  1. medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
  2. general practitioners
  3. the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )

5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association





Primary Outcome Measures :
  1. Confirmed diagnosis of polymyositis / dermatomyositis [ Time Frame: approximately 1 month ]
    recruitment of patients with polymyositis / dermatomyositis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients living in the Normandy with polymyositis / dermatomyositis
Criteria

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)

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): NCT02880527


Locations
France
Rouen University Hospital
Rouen, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Isabelle MARIE, Pr Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02880527     History of Changes
Other Study ID Numbers: 2013/007/HP
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases