Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Dermatomyositis Clinical Trial

— EPIDEMYOSITIS  

Official title:

Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880527
• Other study ID #: 2013/007/HP
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: August 23, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatomyositis
• Polymyositis

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed diagnosis of polymyositis / dermatomyositis	recruitment of patients with polymyositis / dermatomyositis	approximately 1 month	No