Last update : 04/12/2012 | Version : 1 | ID : 2405
General | |
Identification | |
Detailed name | PGRx : Lupus |
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) | Systemic and cutaneous lupus, Systemic lupus erythematosus (SLE) |
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 |
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 lupus are recruited by a network of internal medicine, dermatology, rheumatology and pediatrics centers and the referenst by a network of GPs across France. |
Database objective | |
Main objective | Surveillance and assessment of the risk of lupus 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 an incident lupus declared by the specialist, for which 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 | - 98 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 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05