ITMO public health
Last update : 01/18/2022 | Version : 1 | ID : 74117
| General | |
| Identification | |
| 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 |
| 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 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 Woman |
| Geography area |
National |
| Data collection | |
| Dates | |
| 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 |
| Data | |
| 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 |
| Procedures | |
| 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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