CORPUS - Observational Cohort on Rheumatology Practices and Uses

Head :
Guillemin Francis, CIC-EC NANCY

Last update : 07/05/2014 | Version : 1 | ID : 60035

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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

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