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Active, Not Recruiting

NCT Number: NCT06247722

Real World Use of Tocilizumab Biosimilar studY

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatologische Schwerpunktpraxis Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months after treatment start

    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.

Secondary outcomes

  1. Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar

    Time frame: 12 months after treatment start

    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.

  2. Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12

    Time frame: 12 months after treatment start

  3. Change from Baseline in Patient Global Assessment of Disease Activity at Month 12

    Time frame: 12 months after treatment start

  4. Change from Baseline in Physician Global Assessment of Disease Activity at Month 12

    Time frame: 12 months after treatment start

Sponsors and collaborators

Lead sponsor

Fresenius Kabi SwissBioSim GmbH

Industry

Registry information

Official study title

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

Acronym: RUBY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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