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

August 23, 2016 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Rouen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients living in the Normandy with polymyositis / dermatomyositis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed diagnosis of polymyositis / dermatomyositis
Time Frame: approximately 1 month
recruitment of patients with polymyositis / dermatomyositis
approximately 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/007/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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