- PGRx: Rheumatoid polyarthritis suspicion

Head :
Grimaldi-Bensouda Lamiae

Last update : 10/29/2013 | Version : 1 | ID : 2409

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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: Rheumatoid polyarthritis suspicion
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
Health determinants Genetic
Others (details) Rheumatoid polyarthritis (PAR) suspicion
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 Mixed
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
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Cases of central demyelination are recruited by a network of internal medicine, rheumatology and pediatric centers, and the referral agents by a network of general practitioners, distributed all across the territory.
Database objective
Main objective Surveillance and evaluation of the risk of an initial rheumatoid polyarthritis, associated with drug or vaccine exposure under real treatment situations.
Inclusion criteria For cases: patient, men or women, aged from 18 to 79 included, having a clinico-biological presentation evocative of rheumatoid polyarthritis declared by the specialist, the early symptoms of the episode of which date back less than 12 months.
For controls: patient, men or women aged from 18 to 79 included, having consulted a general practitioner.
Population type
Age 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 - 151 cas/cases - 11125 témoins/referents
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) Terms of data access to be defined.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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