TANDEM - Subcutaneous Tocilizumab in monotherapy or in combination with csDMARD in patients with moderate to severe active Rheumatoid Arthritis and followed by hospital and office-based rheumatologists: Non-interventional study to describe realworld drug retention rate of the biotherapy at 1 year

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Medical data center

Last update : 01/18/2022 | Version : 1 | ID : 74116

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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 Subcutaneous Tocilizumab in monotherapy or in combination with csDMARD in patients with moderate to severe active Rheumatoid Arthritis and followed by hospital and office-based rheumatologists: Non-interventional study to describe realworld drug retention rate of the biotherapy at 1 year
Sign or acronym TANDEM
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML29256
General Aspects
Medical area Rheumatology
Study in connection with Covid-19 No
Pathology (details) Rheumatoid arthritis
Health determinants Medicine
Keywords Tocilizumab
Scientific investigator(s) (Contact)
Name of the director Medical data center
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
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
Database objective
Main objective Primary objective : To assess the drug retention rate of TCZ sc at 12 months under real-world conditions in patients with moderate to severe active RA followed by hospital- and office-based rheumatologists
Secondary objectives :
- To assess the drug retention rate of TCZ sc at 6 and 18 months.
- To compare the drug retention of TCZ sc in monotherapy and in combination with MTX or other csDMARD.
- To describe steroid dosing after introduction of TCZ sc with a stratification on the use of MTX or other csDMARDs at 6, 12 and 18 months.
- To assess adherence to TCZ sc using a French version of the Compliance Questionnaire for Rheumatology 5 (CQR5) and patient diary at 6, 12 and 18 months.
- To evaluate the French version of the CQR5 by assessing the correlation with the data collected from the patient diary data.
- To describe the modalities of use of TCZ sc.
- To describe the management of RA and patients’ healthcare pathway between hospital- and office-based rheumatologists.
- To describe the efficacy of TCZ sc under real-world conditions of use.
- To describe the characteristics of patients treated with TCZ sc and the characteristics of the involved physicians.
- To assess the tolerability profile of TCZ sc under real-world conditions of use.
- To describe the quality of life (QoL) in patients receiving TCZ sc under real-world conditions of use.
Inclusion criteria Inclusion criteria :
- Patients at least 18 years-old.
- Patients with moderate to severe RA not previously treated with TCZ (iv or sc), for whom the rheumatologists have decided to initiate TCZ sc treatment as monotherapy or in combination with another csDMARD.
- Patients who have been informed verbally and in writing about this study, who do not object to their data being electronically processed or subjected to data quality control and who have signed the consent 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
Pathology M05-M14 - Inflammatory polyarthropathies
Gender Male
Woman
Geography area National
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2015
Date of last collection (YYYY or MM/YYYY) 2018
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 286
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Medical registration
Details of collected clinical data Eligibility /Consent form ; Inclusion criteria / Exclusion criteria ; Status ; Demography ; History of Rheumatoid Arthritis and Medical history ; Prior treatments ; Activity of RA : ESR / CRP ; Treatment with RoActemra® sc ; Hospitalization for RA ; Early termination ; Concomitant Treatment ; Adverse Events ; CQR-5/CQ5D/HAQDI.
Presence of a biobank No
Procedures
Data collection method eCRF
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
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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