ITMO public health
Last update : 09/06/2017 | Version : 2 | ID : 8794
| General | |
| Identification | |
| Detailed name | Longitudinal Study on Patients with Rheumatoid Arthritis and Study on Tolerance and Efficacy of Tocilizumab (REGistry-RoAcTEmra) |
| Sign or acronym | REGATE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL REGistry-RoAcTEmra |
| General Aspects | |
| Medical area |
Geriatrics Rheumatology |
| Health determinants |
Medicine |
| Keywords | RA, TCZ, tolerance, comorbidity, efficacy |
| Scientific investigator(s) (Contact) | |
| Name of the director | Morel |
| Surname | Jacques |
| Address | 191 Avenue du Doyen Gaston, Giraud, 34295 Montpellier, Cedex 5, France |
| Phone | +33 (0)4 67 33 73 14 |
| jacquesmorel@yahoo.com | |
| Unit | Service de RheumatologieCHU Lapeyronie |
| Organization | CHU de |
| Name of the director | Sibilia |
| Surname | Jean |
| Address | avenue Molière, 67098 Strasbourg cedex, France. |
| Phone | +33 (0)3 88 12 79 54 |
| jean.sibilia@chru-strasbourg.fr | |
| Unit | Service de rhumatologie, Centre national de références des maladies auto-immunes systémiqueshôpital de HautepierreCHU de Strasbourg |
| Organization | CHU de |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | French Rheumatology Society |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société Française de Rhumatologie |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Club Rhumatiques et Inflammation |
| 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 | The main objective of the REGATE study is to identify the tolerance and efficacy of Tocilizumab currently used for Rheumatoid Arthritis (RA). |
| Inclusion criteria |
- aged 18 or over
- patient with rheumatoid arthritis |
| 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) | 01/2011 |
| Date of last collection (YYYY or MM/YYYY) | 10/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 1,500 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | History, drug intake, DAS28 score, comorbidities such as: Severe infection, cancer, infusion reactions, pregnancy, gastrointestinal perforation, cardiovascular events, cytopenia, cytolysis. |
| Biological data (detail) | Rheumatoid factor, ACPA |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | at 3 and 6 months, then every 6 months for 5 years. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=regate+AND+%28Morel[author]+OR+Sibilia[author]%29 |
| Description | List of publications in 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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