Real World Use of Tocilizumab Biosimilar studY

Last updated: April 22, 2024
Sponsor: Fresenius Kabi SwissBioSim GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT06247722
TOCI-001-CNI
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beenmade by the investigator prior to the inclusion, in accordance with the Summary ofProduct Characteristics (SmPC), local label and physician' current clinical practice
  • Patients able to understand and complete the study questionnaires in local languageduring the study visits
  • Patients are willing to enter the study (signed informed consent)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 600
Study Start date:
March 05, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Rheumatologische Schwerpunktpraxis Berlin

    Berlin, 12161
    Germany

    Active - Recruiting

  • Rheumapraxis Dr. Liebhaber Halle

    Halle, 06128
    Germany

    Active - Recruiting

  • Facharztpraxis für Innere Medizin Ludwigsfelde

    Ludwigsfelde, 14974
    Germany

    Active - Recruiting

  • Rheumatologische Facharztpraxis

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Facharztpraxis für Innere Medizin

    Naumburg, 06618
    Germany

    Active - Recruiting

  • Klinische Forschung

    Planegg, 82152
    Germany

    Active - Recruiting

  • Rheumahaus Potsdam

    Potsdam, 14467
    Germany

    Active - Recruiting

  • Rheumatologische Facharztpraxis Templin

    Templin, 17268
    Germany

    Active - Recruiting

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