ACTSOLO - Evaluation of factors influencing use of Roacterma® as monotherapy in Rheumatoid Arthritis patients in a real life setting

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Medical data center

Last update : 01/18/2022 | Version : 1 | ID : 74117


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General Aspects
Scientific investigator(s) (Contact)
Governance of the database
Additional contact
Type of database
Database objective
Population type
Size of the database
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Detailed name Evaluation of factors influencing use of Roacterma® as monotherapy in Rheumatoid Arthritis patients in a real life setting
Sign or acronym ACTSOLO
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML27873
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
Organization Roche SAS
Participation in projects, networks and consortia No
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 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 a real-life setting the factors influencing the use of RoActemra® as monotherapy or in combination with DMARDs in patients with rheumatoid arthritis
Secondary objectives :
- To describe the characteristics of patients treated with RoActemra® as monotherapy or in combination with another treatment.
- To describe impact of physician characteristics on use of RoActemra® as monotherapy or in combination.
- For patients on RoActemra® monotherapy, to describe reasons for discontinuation or non-use of csDMARDs.
- To evaluate treatment maintenance one year after RoActemra® initiation in a real-life setting.
- To describe efficacy of RoActemra® in real conditions of use.
- To describe effect of RoActemra® on quality of life in real conditions of use.
- To assess safety profile of RoActemra® in real conditions of use.
Inclusion criteria Inclusion criteria :
- Patient >=18 years of age
- Patient with rheumatoid arthritis, for whom the rheumatologist decided to start RoActemra® in combination with a csDMARD or as monotherapy
- Patient having received both oral and written information about the study, without any objections for the use of his/her personal data
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
Geography area National
Data collection
Date of first collection (YYYY or MM/YYYY) 2013
Date of last collection (YYYY or MM/YYYY) 2014
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 603
Database activity Data collection completed
Type of data collected Clinical 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 ; Pain VAS, fatigue VAS, and patient’s global assessment of disease activity ; HAQ-DI, RAID scale, and PASS.
Presence of a biobank No
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
Dedicated website
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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