PEPS - PharmacoEpidemiological study of the imPact of RoActemra® treatment on fatigue in rheumatoid arthritis patientS in a real life setting

Head :
Roche Medical Data Center

Last update : 06/30/2022 | Version : 1 | ID : 74130

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

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
Select all | Invert selection | No selection

Which version do you want to export ?

French version
send
Send
General
Identification
Detailed name PharmacoEpidemiological study of the imPact of RoActemra® treatment on fatigue in rheumatoid arthritis patientS in a real life setting
Sign or acronym PEPS
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML22457
General Aspects
Medical area Rheumatology
Study in connection with Covid-19 No
Pathology (details) Rheumatoid arthritis
Health determinants Iatrogenic
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 a real life setting the evolution of fatigue in patients with moderate to severe RA during the first 4 months of RoActemra® treatment, as well as to search for predictive factors of an improvement in this symptom.

Secondary objectives:
- To describe patient baseline characteristics and level of fatigue experienced at inclusion by the patient population treated with RoActemra®;
- To evaluate the correlation between the evolutions of fatigue as assessed by FACIT-Fatigue questionnaire and VAS fatigue during the first 4 months of RoActemra® treatment;
- To evaluate the time of onset of RoActemra® effect on fatigue in a real life setting;
- To assess the correlation between evolution of fatigue and disease activity during 4 months of RoActemra® treatment;
- To evaluate the PASS of the fatigue scales (FACIT-Fatigue, VAS fatigue, SF36 vitality) after 4 months of RoActemra® treatment;
- To evaluate the correlation between evolution of fatigue and other patient reported outcomes (PROs): pain, quality of sleep, disability, SF36 vitality, anxiety, depression;
- To describe the management of RA patients treated with RoActemra®;
- To describe all adverse events occurring during the study.
Inclusion criteria Inclusion criteria:
- Male or woman aged over 18 years.
- Patients presenting with moderate to severe rheumatoid arthritis and for which treatment with RoActemra(R) was planned by the investigator;
- Patients willing and able to complete, during consultations and at home, the study questionnaires aimed at evaluating the impact of their disease and treatment;
- Patients who received complete written and oral information about the study, and who gave their consent for future automated processing of the data generated during the study.

Exclusion criteria:
- Patient with known hypersensitivity to RoActemra®, or to any constituent of the study medication;
- Patient presenting with an active concomitant infection;
- Patient currently participating in a clinical trial aimed at evaluating another treatment in rheumatoid arthritis.
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) 2010
Date of last collection (YYYY or MM/YYYY) 2011
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 721
Data
Database activity Data collection completed
Type of data collected Clinical data
Clinical data (detail) Medical registration
Details of collected clinical data Patient demographic characteristics - History of rheumatoid arthritis - Concomitant treatments - Tender and swollen joint counts - Biological parameters - Management of rheumatoid arthritis - Adverse events - FACIT-Fatigue - VAS fatigue - VAS pain - VAS disease activity - VAS quality of sleep - HAQ-DI - SF36 vitality - HADS - PASS Fatigue.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Medicines consumption
Procedures
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

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05