Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Completed

• Conditions: Dermatomyositis; Polymyositis
• Interventions: Other: Patients with polymyositis / dermatomyositis

• Registration Number: NCT02880527
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2016-08
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with polymyositis / dermatomyositis	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

Primary Outcome Measures

Name	Time	Method
Confirmed diagnosis of polymyositis / dermatomyositis	approximately 1 month	recruitment of patients with polymyositis / dermatomyositis

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France