Real World Use of Tocilizumab Biosimilar studY

Rheumatoid Arthritis Clinical Trial

— RUBY  

Official title:

A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247722
• Other study ID #: TOCI-001-CNI
• Status: Recruiting
• Start date: March 5, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: Fresenius Kabi SwissBioSim GmbH
• Contact: Clinical Developement Director
• Phone: +41223076100
• Email: medinfo_biosim[@]fresenius-kabi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients initially diagnosed with moderate to severe rheumatoid arthritis (RA) according to ACR/EULAR 2010 rheumatoid arthritis classification criteria
• Patients for whom the decision to prescribe Tyenne, a tocilizumab biosimilar has been made by the investigator prior to the inclusion, in accordance with the Summary of Product Characteristics (SmPC), local label and physician' current clinical practice
• Patients able to understand and complete the study questionnaires in local language during the study visits
• Patients are willing to enter the study (signed informed consent)

Exclusion Criteria:

• Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi SwissBioSim GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar	A patient is considered to still be on tocilizumab biosimilar treatment (persistence equal "Yes") if no permanent discontinuation of the tocilizumab biosimilar treatment and no lost to follow-up is reported by the investigator before the visit. A patient will be considered to have discontinued the tocilizumab biosimilar (not persistent) at 6 month timepoint if a) the investigator reports a permanent discontinuation of the treatment before the timepoint or b) the patient is lost to follow-up at the timepoint. Temporary cessations of the biosimilar will not be considered as treatment discontinuation, and the treatment will be considered persistent.	6 months after treatment start
Secondary	Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar	A patient is considered to still be on tocilizumab biosimilar treatment (persistence equal "Yes") if no permanent discontinuation of the tocilizumab biosimilar treatment and no lost to follow-up is reported by the investigator before the visit. A patient will be considered to have discontinued the tocilizumab biosimilar (not persistent) at 12 month timepoint if a) the investigator reports a permanent discontinuation of the treatment before the timepoint or b) the patient is lost to follow-up at the timepoint. Temporary cessations of the biosimilar will not be considered as treatment discontinuation, and the treatment will be considered persistent.	12 months after treatment start
Secondary	Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12		12 months after treatment start
Secondary	Change from Baseline in Patient Global Assessment of Disease Activity at Month 12		12 months after treatment start
Secondary	Change from Baseline in Physician Global Assessment of Disease Activity at Month 12		12 months after treatment start