Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

NCT02880527 | Completed

• 1 other identifier: 2013/007/HP
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

Polymyositis; Dermatomyositis

Outcome Measures

Primary Outcomes (1)

• Confirmed diagnosis of polymyositis / dermatomyositis

  recruitment of patients with polymyositis / dermatomyositis

  approximately 1 month

Study Arms (1)

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

Interventions

Patients with polymyositis / dermatomyositis OTHER

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

patients with polymyositis / dermatomyositis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living in the Normandy with polymyositis / dermatomyositis

You may qualify if:

• patients with polymyositis / dermatomyositis, meeting the diagnostic criteria for ENMC;
• patient living Normandy ;
• patient has been informed and has given its verbal agreement ;

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Polymyositis; Dermatomyositis

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Isabelle MARIE, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

FR (1)