NCT06247722Active, not recruiting
Real World Use of Tocilizumab Biosimilar studY
A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 22 Jan 2024
- Start date
- 5 Mar 2024
- Primary completion date
- 5 Mar 2026
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbH
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06247722
What you commit to
- Study type: Observational
- Planned participants: 600
- From 5 Mar 2024 to the primary completion date, 5 Mar 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatologische Schwerpunktpraxis Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Rheumapraxis Dr. Liebhaber Halle Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Facharztpraxis für Innere Medizin Ludwigsfelde Coordinator of this site? Confirm its status | Ludwigsfelde | Germany | Unknown status |
| Rheumatologische Facharztpraxis Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| Facharztpraxis für Innere Medizin Coordinator of this site? Confirm its status | Naumburg | Germany | Unknown status |
| Klinische Forschung Coordinator of this site? Confirm its status | Planegg | Germany | Unknown status |
| Rheumahaus Potsdam Coordinator of this site? Confirm its status | Potsdam | Germany | Unknown status |
| Rheumatologische Facharztpraxis Templin Coordinator of this site? Confirm its status | Templin | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.