ITMO public health
Last update : 11/03/2015 | Version : 2 | ID : 6829
| General | |
| Identification | |
| Detailed name | Research Axed on Tolerance of BIOtherapies |
| Sign or acronym | RATIO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Infectious diseases |
| Pathology (details) | Infections |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Anti-TNF-alpha, tolerance |
| Scientific investigator(s) (Contact) | |
| Name of the director | Mariette |
| Surname | Xavier |
| Address | 63 rue Gabriel Peri 94270 LE KREMLIN BICETRE |
| Phone | +33 (0)1 45 21 21 21 |
| xavier.mariette@bct.aphp.fr | |
| Organization | AP-HP Hôpital |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | - Institut National pour la Santé et la Recherche Médicale- Laboratoire Abbott- Laboratoire Schering Plough- Laboratoire Wyeth |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | AP-HP Hôpital Bicêtre |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Agence Française de Sécurité Sanitaire des Produits de Santé |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Patients enrolled at time opportunistic infection occurs and subsequently monitored over a prolonged period. |
| Database objective | |
| Main objective | To describe cases of opportunistic infection, severe bacterial infection and lymphoma in patients who are receiving or have received anti-TNF-alpha therapy. |
| Inclusion criteria | - Men or women - receiving or have received anti-TNFα therapy |
| Population type | |
| Age |
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) |
| 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) | 02/2004 |
| Date of last collection (YYYY or MM/YYYY) | 01/2007 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 57 711 par an / by year |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Capture-recapture system used to control and improve recorded data for each case. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 3-year observational follow-up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://rheumatology.oxfordjournals.org/content/50/1/222.long |
| Link to the document | http://tinyurl.com/HAL-RATIO |
| Description | Liste des publications dans HAL |
| Link to the document | http://tinyurl.com/PUBMED-RATIO |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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