ITMO public health
Last update : 03/06/2012 | Version : 1 | ID : 92
| General | |
| Identification | |
| Detailed name | Profiles of patients suffering from MS-RR according to the delay of appearance of the first attack after initiation the first immunomodulator treatment |
| Sign or acronym | OPISEP |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Numéro CNIL 908245, CPP = NA, AFSSAPS = NA |
| General Aspects | |
| Medical area |
Neurology |
| Others (details) | multiple sclerosis MS-RR (Relapsing - Remitting) |
| Keywords | central nervous system, first attack under IMD treatment |
| Scientific investigator(s) (Contact) | |
| Name of the director | VIGNAL |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| 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 institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Describe the profiles of patients suffering from MS-RR according to the delay of appearance of the first attack after initiation the first immunomodulator treatment. |
| Inclusion criteria |
• Patient of legal age (≥ 18 years) • Patient suffering from MS-RR • Patient having, after initiation the first immunomodulator treatment, a recent first attack (less than 10 days) • Patient accepting to participate in the survey Criteria for non-inclusion • Patient participating in clinical research (pre-market authorization) |
| 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 | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | Less than 500 individuals |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Face to face interview |
| Paraclinical data (detail) | MRI |
| Biological data (detail) | Search for IFN neutralizing antibodies |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Others |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Other (detail) | EDSS scale |
| 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 |
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