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