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Real World Use of Tocilizumab Biosimilar studY - Trial NCT06247722

Access comprehensive clinical trial information for NCT06247722 through Pure Global AI's free database. This phase not specified trial is sponsored by Fresenius Kabi SwissBioSim GmbH and is currently Not yet recruiting. The study focuses on Rheumatoid Arthritis. Target enrollment is 600 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06247722
Not yet recruiting
Trial Details
ClinicalTrials.gov โ€ข NCT06247722
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Real World Use of Tocilizumab Biosimilar studY
A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients

Study Focus

Rheumatoid Arthritis

Observational

Sponsor & Location

Fresenius Kabi SwissBioSim GmbH

Timeline & Enrollment

N/A

Feb 28, 2024

Feb 28, 2026

600 participants

Primary Outcome

Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar

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.

ICD-10 Classifications

Rheumatoid arthritis, unspecified
Other rheumatoid arthritis
Other specified rheumatoid arthritis
Rheumatoid arthritis with involvement of other organs and systems
Seronegative rheumatoid arthritis

Data Source

ClinicalTrials.gov

NCT06247722

Non-Device Trial