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Real World Use of Tocilizumab Biosimilar studY
Sponsor: Fresenius Kabi SwissBioSim GmbH
Summary
The goal of this non interventional study is to evaluate the use of Tyenne, a tocilizumab biosimilar, in a real world setting in Rheumatoid Arthritis (RA) patients over a period of 12 months. The main questions it aims to answer are: * What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 6 months after treatment start? * What is the patients' persistence on Tyenne (patient's ability to continue the treatment for the prescribed duration), 12 months after treatment start? The decision of prescribing Tyenne will be done by the physician independently, prior to patient enrolment in the study. Enrolled patients will be followed for 12 months following Tyenne treatment start, or until they permanently discontinue Tyenne. There will be one baseline visit and three follow-up visits at approximately 3, 6 and 12 months after Tyenne treatment initiation. All follow-up visits will be conducted according to the physician current clinical practice and are not imposed due to this protocol.
Official title: A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2024-03-05
Completion Date
2026-03-31
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Locations (8)
Rheumatologische Schwerpunktpraxis Berlin
Berlin, Germany
Rheumapraxis Dr. Liebhaber Halle
Halle, Germany
Facharztpraxis für Innere Medizin Ludwigsfelde
Ludwigsfelde, Germany
Rheumatologische Facharztpraxis
Magdeburg, Germany
Facharztpraxis für Innere Medizin
Naumburg, Germany
Klinische Forschung
Planegg, Germany
Rheumahaus Potsdam
Potsdam, Germany
Rheumatologische Facharztpraxis Templin
Templin, Germany