Real World Use of Tocilizumab Biosimilar studY (RUBY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Clinical Developement Director; Phone Number: +41223076100; Email: medinfo_biosim@fresenius-kabi.com

Study Locations

• Germany
  • Berlin, Germany, 12161
    • Recruiting
    • Rheumatologische Schwerpunktpraxis Berlin
  • Halle, Germany, 06128
    • Recruiting
    • Rheumapraxis Dr. Liebhaber Halle
  • Ludwigsfelde, Germany, 14974
    • Recruiting
    • Facharztpraxis für Innere Medizin Ludwigsfelde
  • Magdeburg, Germany, 39104
    • Recruiting
    • Rheumatologische Facharztpraxis
  • Naumburg, Germany, 06618
    • Recruiting
    • Facharztpraxis für Innere Medizin
  • Planegg, Germany, 82152
    • Recruiting
    • Klinische Forschung
  • Potsdam, Germany, 14467
    • Recruiting
    • Rheumahaus Potsdam
  • Templin, Germany, 17268
    • Recruiting
    • Rheumatologische Facharztpraxis Templin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include male and female adult patients with moderate to severe rheumatoid arthritis (RA) who

• were prescribed Tyenne, a tocilizumab biosimilar
• meet all the study inclusion criteria
• meet none of the exclusion criteria
• provide written informed consent to participate.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12		12 months after treatment start
Change from Baseline in Patient Global Assessment of Disease Activity at Month 12		12 months after treatment start
Change from Baseline in Physician Global Assessment of Disease Activity at Month 12		12 months after treatment start

Collaborators and Investigators

• Sponsor: Fresenius Kabi SwissBioSim GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; biosimilar; tocilizumab; persistence; real world use; biosimilar switch; Tyenne
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: TOCI-001-CNI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No