3A-Pégase - Programme d'études 3A-Pégase (Pharmaco-Epidémiologie de la Gonarthrose et de la coxArthoSE)

Head :
Grimaldi - Bensouda Lamiae

Last update : 06/19/2012 | Version : 1 | ID : 2611

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

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
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Programme d'études 3A-Pégase (Pharmaco-Epidémiologie de la Gonarthrose et de la coxArthoSE)
Sign or acronym 3A-Pégase
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation N°CNIL : 909473
General Aspects
Medical area Rheumatology
Others (details) Gonarthrosis, coxarthrosis
Keywords Symptomatic slow-acting anti-arthritics, intake of NSAIDs
Scientific investigator(s) (Contact)
Name of the director Grimaldi - Bensouda
Surname Lamiae
Address LA-SER, 10, Place de Catalogne - 75014 Paris
Phone + 33 (0)1 55 42 53 00
Email contact@la-ser.com
Organization LA-SER
Collaborations
Funding
Funding status Private
Details EXPANSCIENCE, Pierre FABRE, GENEVRIER, NEGMA, NOVARTIS, ROTTAPHARM
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) Longitudinal study (except cohorts)
Database recruitment is carried out by an intermediary A selection of health care professionals
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Eligible patients are recruited by general practitioners or participating private-practice rheumatologists and exercising in metropolitan France
Database objective
Main objective Evaluate the impact (benefit and risk) of osteoarthritis treatments in terms of public health.
Inclusion criteria Men or women, aged 18 years or older, having painful gonarthrosis and/or coxarthrosis, non-treated or treated with a symptomatic slow-acting anti-arthritic for less than 3 months.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area Metropolitan France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 03/2010
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 1900 patients
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
Data collection method The data is collected using medical questionnaires and during standardized telephone interviews with the patient included. The telephone interviews are conducted after sending an interview guide beforehand (visual support).
Participant monitoring Yes
Details on monitoring of participants Patients included are followed for 12 months. Follow-up for patients included comprises 4 telephone interviews: 1 month after inclusion, then at 4, 8 and 12 months of follow-up. After the 12 months of follow-up, a medical questionnaire is completed by the participating practitioner.
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 disseminating and access to the data are being finalized.
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

View Edit Create here