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ACTIVE NOT RECRUITING
NCT06247722

Real World Use of Tocilizumab Biosimilar studY

Sponsor: Fresenius Kabi SwissBioSim GmbH

View on ClinicalTrials.gov

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

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