EPIDEMYOSITIS: Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT02880527
Collaborator
(none)
187
1
22
8.5

Study Details

Study Description

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 Phase
  • Other: Patients with polymyositis / dermatomyositis

Study Design

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 :
Jul 1, 2014
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
patients with polymyositis / dermatomyositis

recruitment of patients with polymyositis / dermatomyositis will be used: 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

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

Outcome Measures

Primary Outcome Measures

  1. Confirmed diagnosis of polymyositis / dermatomyositis [approximately 1 month]

    recruitment of patients with polymyositis / dermatomyositis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rouen University Hospital Rouen France

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

  • Principal Investigator: Isabelle MARIE, Pr, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02880527
Other Study ID Numbers:
  • 2013/007/HP
First Posted:
Aug 26, 2016
Last Update Posted:
Aug 26, 2016
Last Verified:
Aug 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 26, 2016