CEMARA - Inflammatory Diseases in Paediatric Rheumatology
Head :
Quartier-dit-Maire Pierre, UNITE D’IMMUNO-HEMATOLOGIE PEDIATRIQUE
Last update : 06/30/2015 | Version : 2 | ID : 60138
| General | |
| Identification | |
| Detailed name | Inflammatory Diseases in Paediatric Rheumatology |
| Sign or acronym | CEMARA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 1187326 (23/05/2007) |
| General Aspects | |
| Medical area |
Rheumatology |
| Health determinants |
Genetic |
| Keywords | adverse events, life-threatening, sequelae, embryonic/foetal impairment, neoplasia, Health episodes, death, hospitalisation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Quartier-dit-Maire |
| Surname | Pierre |
| Address | 75015 PARIS |
| pierre.quartier@aphp.fr | |
| Unit | UNITE D’IMMUNO-HEMATOLOGIE PEDIATRIQUE |
| Organization | UIH) ET INSERM U768 HOPITAL NECKER-ENFANTS MALADES |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | CENTRE DE REFERENCE MALADIES RARES « ARTHRITES JUVENILES » |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de Santé et Recherche Médicale |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | APHP |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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. | Inclusion method: Prospective Inclusion cut-off date not determined |
| Database objective | |
| Main objective | General objective: To evaluate the risk of the occurrence of serious adverse events under or after exposure to prescribed biotherapy for rheumatoid arthritis. The selected population consists of a growing proportion of patients exposed to early introductory biotherapy from childhood (TNF-Alpha antagonists, IL-1, IL-6, anti-CD20, CTLA-4Ig etc.), sometimes in combination with immunosuppressants Secondary objectives: 1/ To simultaneously assess the risk of the occurrence of serious adverse events (SAE) in the absence of biotherapy for the entire paediatric rheumatology cohort. 2/ To assess the risk of SAEs in the presence or absence of biotherapy for main sub-cohorts: juvenile idiopathic arthritis, paediatric autoimmune diseases, systemic vasculitis and childhood collagen diseases including lupus. 3/ To describe progressive characteristics and treatment of these patients in more detail. 4/ To further basic, clinical and epidemiological studies by creating a biobank and connections with other cohorts and registries 5/ To promote the assessment of medical practices and the application of national protocol recommendations for diagnosis and care. |
| Inclusion criteria | Patients included in the CEMARA database must have a diagnosis relevant to the label "juvenile arthritis" in the rare disease reference centre = inflammatory paediatric rheumatology diseases identified in the CEMARA thesaurus (and Orphanet thesauraus) belonging to one of the following 4 categories: juvenile idiopathic arthritis, other juvenile arthritis, paediatric autoinflammatory diseases, systemic diseases and paediatric vasculitis |
| Population type | |
| Age |
Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2007 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1068 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA DNAc/RNAm |
| Details of biobank content | Serum bank, plasma bank, DNA bank, RNA (TEMPUS TUBES OR EQUIVALENT) |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview: Direct input Cinical examiniations: Direct input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDc |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://cemara.org |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams. Contractual access. Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
