CORPUS - Observational Cohort on Rheumatology Practices and Uses
Head :
Guillemin Francis, CIC-EC NANCY
Last update : 07/05/2014 | Version : 1 | ID : 60035
| General | |
| Identification | |
| Detailed name | Observational Cohort on Rheumatology Practices and Uses |
| Sign or acronym | CORPUS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL : 14/11/2006 |
| General Aspects | |
| Medical area |
Rheumatology |
| Others (details) | Spondyloarthritis, juvenile arthritis |
| Keywords | Quality of life, health, healthcare usage, resumption of activity, biotherapy treatment, side effects, switch |
| Scientific investigator(s) (Contact) | |
| Name of the director | Guillemin |
| Surname | Francis |
| Phone | + 33 (0)3 83 85 21 63 |
| francis.guillemin@chu-nancy.fr | |
| Unit | CIC-EC NANCY |
| Organization | CHU |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | WYETH PHARMACEUTICALS FRANCE, SCHERING PLOUGH, ABBOTT FRANCE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Nancy |
| 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 is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Inclusion cut-off date: 01/02/2010 Other bodies active in creating this cohort: SFR DNFMI SFD |
| Database objective | |
| Main objective | General objective: to determine the impact of basic prescribed treatment with or without prescribed biotherapy, focussing on the impact of changes in biotherapy over time. Epidemiological recording of the occurrence of adverse events in the long term. Secondary objective: To investigate the role of biotherapy in patient treatment by determining its position in prescribed treatment order during therapeutic sequences. |
| Inclusion criteria | All patients that have never received biotherapy and are monitored in one of the participating centres: - patients with active rheumatoid arthritis (with or without prescription), DAS28 score greater than 3.2 regardless of disease onset age, with hand and feet x-rays in the last 3 months - active idiopathic juvenile arthritis (JIA) (with or without prescription), following methrexate intolerance or failure, x-ray in the last 3 months - active (with or without prescription) spondyloarthritis (SPA) (ankylosing or psoriatic arthritis) regardless of disease onset age, pelvic and spinal x-ray in the last 3 months, or of hands and feet according to peripheral or axial form |
| 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 | Muticentic cohort throughout France (133 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 02/2007 |
| Date of last collection (YYYY or MM/YYYY) | 02/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 640 (407 PAR, 192 SPA, 41 AJI) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Presence of a biobank |
No |
| Health parameters studied |
Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: optical input from a paper questionnaire Clinical examinations: optical input from a form Biological analysis: optical input from a paper form |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 5 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may not be used by academic teams. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
