Clinical trial NCT06247722: Real World Use of Tocilizumab Biosimilar studY
Official title: A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: tocilizumab
rheumatoid arthritis
persistence
real world use
biosimilar
biosimilar switch
Tyenne
Lead sponsor: Fresenius Kabi SwissBioSim GmbH
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar
timeFrame: 6 months after treatment start
Secondary outcomes:
measure: Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar
timeFrame: 12 months after treatment start
measure: Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12
timeFrame: 12 months after treatment start
measure: Change from Baseline in Patient Global Assessment of Disease Activity at Month 12
timeFrame: 12 months after treatment start
measure: Change from Baseline in Physician Global Assessment of Disease Activity at Month 12
timeFrame: 12 months after treatment start
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Rheumatologische Schwerpunktpraxis Berlin
city: Halle
country: Germany
facility: Rheumapraxis Dr. Liebhaber Halle
city: Ludwigsfelde
country: Germany
facility: Facharztpraxis für Innere Medizin Ludwigsfelde
city: Magdeburg
country: Germany
facility: Rheumatologische Facharztpraxis
city: Naumburg
country: Germany
facility: Facharztpraxis für Innere Medizin
city: Planegg
country: Germany
facility: Klinische Forschung
city: Potsdam
country: Germany
facility: Rheumahaus Potsdam
city: Templin
country: Germany
facility: Rheumatologische Facharztpraxis Templin
Study officials:
References: