Real World Use of Tocilizumab Biosimilar studY

N/AActive Not RecruitingNCT06247722

Fresenius Kabi SwissBioSim GmbH600 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

600

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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, Germany

Outcomes

Primary Outcomes

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.

Time frame: 6 months after treatment start

Secondary Outcomes

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.

Time frame: 12 months after treatment start

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

Time frame: 12 months after treatment start

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

Time frame: 12 months after treatment start

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

Time frame: 12 months after treatment start