74117117/01/2022Validated04/02/2022Camille Bachothttp://epidemiologie-france.aviesan.fr/en/content/view/full/91000http://epidemiologie-france.aviesan.fr/en/ccontent/xml/(NodeId)/91000Evaluation of factors influencing use of Roacterma® as monotherapy in Rheumatoid Arthritis patients in a real life settingACTSOLOML27873RheumatologyNoRheumatoid arthritis MedicineTocilizumabMedical data centerdata_sharing_france@roche.comRoche SASNoPrivateRoche SASPrivateYesStudy databasesCohort studyA selection of health institutions and servicesMedication(s) takenNoPrimary 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 :
- 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 dataAdulthood (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)Sick populationM05-M14 - Inflammatory polyarthropathiesMaleWomanNational20132014[500-1000[ individuals603Data collection completedClinical dataMedical registrationValidation 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.NoGCP/GVPYesMonitoring by contact with the referring doctorNohttp://epidemiologie-france.aviesan.fr/enhttps://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.htmlAccess on specific project onlyAccess on specific project only