Real World Use of Tocilizumab Biosimilar studY (RUBY)

Fresenius Kabi

Status: Active, not recruiting

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT06247722

TOCI-001-CNI

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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