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