ITMO public health
Last update : 10/18/2017 | Version : 1 | ID : 73330
| General | |
| Identification | |
| Detailed name | A retrospective study on the epidemiology and treatments of patients with multiple sclerosis (MS) in Metropolitan France |
| Sign or acronym | MS Network |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS : 14.296 bis; CNIL: 914245 |
| General Aspects | |
| Medical area |
Neurology |
| Pathology (details) | Multiple Sclerosis |
| Health determinants |
Medicine |
| Keywords | Multiple Sclerosis |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pr CLANET |
| Surname | Michel |
| Address | Toulouse |
| Name of the director | Pr DE SEZE |
| Surname | Jerôme |
| Address | Strasbourg |
| Name of the director | Pr DEFER |
| Surname | Gilles |
| Address | Caen |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | MS networks |
| Funding | |
| Funding status |
Private |
| Details | Merck |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Merck |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Labelling and database evaluation | Scientific Committee |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
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 is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Observational, descriptive, and retrospective study based on the data available in health-care centres specialised in MS. |
| Database objective | |
| Main objective |
Describe the demographic characteristics of patients with Multiple Sclerosis (MS) in Metropolitan France and describe their therapeutic management
Secondary objectives: - describe the conditions of use of long-term MS treatments; - evaluate the therapeutic effect in real observational situations of the long-term MS treatments; - describe the reasons for change and discontinuation of long-term MS treatments; - evaluate compliance to treatment with Rebif |
| Inclusion criteria | Patients monitored in health-care centres specialised in MS and whose data was recorded in the database of each centre. |
| Population type | |
| Age |
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) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | VI - Diseases of the nervous system |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2015 |
| Date of last collection (YYYY or MM/YYYY) | 01/2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 15039 (11 centres) |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Sociodemographic characteristics of patients; Diagnosis of the disease; Clinical evaluation of the disease; History of MS treatments and ongoing treatments; Effectiveness of treatments / Compliance data (Rebif) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Quality of life/perceived health (detail) | Level/Progression of disability (EDSS score, MSSS score) |
| Procedures | |
| Data collection method | Extraction, processing and analysis of databases of French health-care centres managing MS / Extraction of the injection log of the RebiSmart system |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) |
Access terms and conditions are being defined
Contact: juliette.longin@merckgroup.com |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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