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