Real World Use of Tocilizumab Biosimilar studY
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT06247722
- Lead Sponsor
- Fresenius Kabi SwissBioSim GmbH
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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)
- Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar 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 Outcome Measures
Name Time Method 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 Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar 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.
Change from Baseline in Physician Global Assessment of Disease Activity at Month 12 12 months after treatment start
Trial Locations
- Locations (8)
Rheumatologische Facharztpraxis Templin
🇩🇪Templin, Germany
Rheumahaus Potsdam
🇩🇪Potsdam, Germany
Facharztpraxis für Innere Medizin Ludwigsfelde
🇩🇪Ludwigsfelde, Germany
Rheumatologische Schwerpunktpraxis Berlin
🇩🇪Berlin, Germany
Rheumapraxis Dr. Liebhaber Halle
🇩🇪Halle, Germany
Rheumatologische Facharztpraxis
🇩🇪Magdeburg, Germany
Klinische Forschung
🇩🇪Planegg, Germany
Facharztpraxis für Innere Medizin
🇩🇪Naumburg, Germany