- PGRx : Myositis

Head :
Grimaldi-Bensouda Lamiae

Last update : 04/12/2012 | Version : 1 | ID : 2413

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name PGRx : Myositis
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CNIL : 907.309
General Aspects
Medical area Internal medicine
Rare diseases
Rheumatology
Others (details) Incident cases of myositis and dermatomyositis
Keywords pharmaco-epidemiology
Scientific investigator(s) (Contact)
Name of the director Grimaldi-Bensouda
Surname Lamiae
Address 10 place de Catalogne, 75014 Paris
Phone + 33 (0)1 55 42 53 00
Email contact@la-ser.com
Collaborations
Funding
Funding status Private
Details LA-SER
Governance of the database
Sponsor(s) or organisation(s) responsible LA-SER
Organisation status Private
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Case control study
Database recruitment is carried out by an intermediary A selection of health institutions and services
A population file
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Cases of myositis and dermatomyositis are recruited by a network of internal medicine, dermatology, rheumatology and pediatrics centers and the referents by a network of GPs across the territory.
Database objective
Main objective Surveillance and assessment of the risk of myositis and/or dermatomyositis associated with drug or vaccine use under real life situations.
Inclusion criteria For cases: patient, man and woman aged from 0 to 79 years inclusive, with a clinico-biological presentation evocative of myositis/dermatomyositis declared by the specialist, for which the first symptoms of the episode began less than 12 months ago.
For controls: patient, man and woman aged from 0 to 79 years, who have consulted a GP.
Population type
Age Newborns (birth to 28 days)
Infant (28 days to 2 years)
Early childhood (2 to 5 years)
Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered General population
Gender Male
Woman
Geography area International
Detail of the geography area France, Italy, Spain, United Kingdom, Canada
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 04/2008
Size of the database
Size of the database (number of individuals) [10 000-20 000[ individuals
Details of the number of individuals - 57 cas/cases - 11125 référents/controls
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Declarative data (detail) Phone interview
Presence of a biobank No
Health parameters studied Health event/morbidity
Procedures
Participant monitoring No
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) methods for accessing the database are currently being defined
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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