RUBY: Real world Use of tocilizumab Biosimilar study
Research type
Research Study
Full title
A multinational, prospective, non-interventional study, to assess real world use of a tocilizumab biosimilar in rheumatoid arthritis patients. RUBY: Real world Use of tocilizumab Biosimilar studY
IRAS ID
1009371
Contact name
Graziella Pourcel
Contact email
Sponsor organisation
Fresenius Kabi SwissBioSim GmbH
Research summary
Rheumatoid arthritis (RA) is a chronic, potentially debilitating disease characterized by inflammation of the joints leading to joint damage, functional disability, pain, poor quality of life and premature mortality. This is non-interventional study aims to assess real world use of a tocilizumab biosimilar in rheumatoid arthritis patients treatment. Tocilizumab, recombinant humanized monoclonal antibody, a biological disease-modifying antirheumatic drug is worldwide approved. Patients are selected by the study doctor after clinical decision to prescribe the tocilizumab FK biosimilar is made. There are two types of patients, initiation of treatment naive patients (first time receiving tocilizumab) , and second, switched from the originator product to tocilizumab FK biosimilar. Enrolled patients will be followed for 12 months once they start receiving tocilizumab biosimilar treatment, or until they permanently discontinue FK tocilizumab biosimilar product, whichever occurs first. Data collection will be performed ideally during four study visits ( Baseline, 3 month follow-up , 6 months follow-up and 12-months follow-up). Patients will be asked to complete questionnaires (online or in a paper format) during the study visits. All follow-up visits will be conducted according to the doctor's current clinical practice and will not be affected by this protocol. The study will end as soon the last study patient has completed last assessment 1 year after the study enrolment or has discontinued earlier. Patients who discontinue the treatment temporarily will continue participating in the study until the data collection completion or FK tocilizumab permanent withdrawal, whichever occurs first. The main endpoint is persistence of tocilizumab. Sample size is 600 pts. and approximately 60 sites plan to recruit from four EU countries including the UK.
REC name
Wales REC 2
REC reference
24/WA/0009
Date of REC Opinion
16 Jan 2024
REC opinion
Unfavourable Opinion