ITMO public health
Last update : 02/03/2012 | Version : 2 | ID : 122
| General | |
| Identification | |
| Detailed name | Survey of the therapeutic management of rheumatoid arthritis in France in 2006 |
| Sign or acronym | OPALE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 833542 version 11 |
| General Aspects | |
| Medical area |
Rheumatology |
| Health determinants |
Genetic |
| Others (details) | rheumatoid arthritis |
| Keywords | Rheumatoid arthritis, epidemiology, DMARD, treatments |
| Scientific investigator(s) (Contact) | |
| Name of the director | Bregman |
| Surname | Bruno |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| bruno.bregman@bms.com | |
| Unit | Bristol-Myers Squibb |
| Name of the director | Schmidely |
| Surname | Nathalie |
| Address | 3, rue J. Monier - 92500 Rueil Malmaison |
| Phone | +33 (0)1 58 83 60 00 |
| nathalie.schmidely@bms.com | |
| Unit | Bristol-Myers Squibb |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Bristol-Myers Squibb |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Bristol-Myers Squibb (BMS) |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| 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. | Random sampling in clusters |
| Database objective | |
| Main objective | Describe the therapeutic pratice used by French rhumatologists in patients suffering from rheumatoid arthritis patients, and describe the treatment patterns used, in a general manner and according to the patients' and disease characteristics. |
| Inclusion criteria |
Register Part: M/F >=18 years, with a midl to severe rheumatoid arthritis currently treated or not treated with either symptomatic agents or DMARD (disease-modifying anti-rheumatism drug treatment) (biological or non-biological), seen in rheumatology clinic visit. Detailed Study Part: patients eligible for the register part, currently treated or initiating a first DMARD (disease-modifying anti-rheumatism drug treatment) (biological or non-biological) at the time of inclusion in the study |
| 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) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1600 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | ESR, CRP, Rheumatoid factor, HLA DR4, Anti CCP |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Paper or electronic form |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-OPALE |
| Description | |
| Link to the document | http://tinyurl.com/HAL-OPALE |
| Description | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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