SPARE-1 - Description in real life of glucocorticoid-sparing in patients treated with Roactemra® for moderate to severe rheumatoid arthritis

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Roche Medical Data Center

Last update : 06/30/2022 | Version : 1 | ID : 74129

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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 Description in real life of glucocorticoid-sparing in patients treated with Roactemra® for moderate to severe rheumatoid arthritis
Sign or acronym SPARE-1
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML25634
General Aspects
Medical area Rheumatology
Study in connection with Covid-19 No
Pathology (details) Moderate to severe rheumatoid arthritis
Health determinants Medicine
Keywords Tocilizumab
Scientific investigator(s) (Contact)
Name of the director Roche Medical Data Center
Address 4 cours de l'Ile Seguin - 92650 BOULOGNE-BILLANCOURT
Email data_sharing_france@roche.com
Organization Roche SAS
Collaborations
Participation in projects, networks and consortia No
Funding
Funding status Private
Governance of the database
Sponsor(s) or organisation(s) responsible Roche SAS
Organisation status Private
Presence of scientific or steering committees Yes
Additional contact
Name of the contact https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html
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
Database objective
Main objective Primary objective : To describe in real life the glucocorticoid-sparing effect after 12 months of treatment with RoActemra® in patients with moderate to severe RA and to determine predictive factors.

Secondary objectives:
1. to describe the characteristics of the population at baseline;
2. to evaluate efficacy of RoActemra® (EULAR response and/or glucocorticoid dosage) in real life;
3. to describe therapeutic management of RA [glucocorticoids and/or conventional Disease-Modifying Anti-Rheumatic Drug(s) (DMARDs) in combination with RoActemra®];
4. to describe change in functional capacity of patients and impact of the disease on the patient over time during follow-up (HAQ-DI and RAID self-report questionnaires);
5. to assess safety of RoActemra®.
Inclusion criteria Inclusion criteria:
- Patients aged 18 years and older;
- Patients with moderate to severe rheumatoid arthritis;
- Patients for whom the rheumatologist decided to initiate treatment with RoActemra®;
- Patients taking oral glucocorticoids >5 mg/day of prednisone or equivalent for at least 3 months;
- Patients having received oral and written information about the study and having raised no objections to the collection and computer processing of his/her personal data.

Exclusion criteria:
- Patients participating in a clinical trial on rheumatoid arthritis at time of inclusion could not participate to the study.
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
Pathology M05-M14 - Inflammatory polyarthropathies
Gender Male
Woman
Geography area National
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2011
Date of last collection (YYYY or MM/YYYY) 2013
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 321
Data
Database activity Data collection completed
Type of data collected Clinical data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data Validation of inclusion and exclusion criteria - Sociodemographic data - Medical history and concomitant diseases - RA history, previous and/or ongoing RA treatments - Most recent clinical and biological data - Physician global assessment of RA activity (asymptomatic to very severe) - RA treatments and reason for discontinuation where applicable - Treatment with RoActemra® - Adverse events - Reason for early study discontinuation - HAQ-DI, RAID scale.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Medicines consumption
Procedures
Data collection method paper
Classifications used CDISC
Quality procedure(s) used GCP/GVP
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the referring doctor
Links to administrative sources No
Promotion and access
Promotion
Access
Dedicated website https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html
Presence of document that lists variables and coding procedures Yes
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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