Evaluating the use of a tocilizumab biosimilar in rheumatoid arthritis patients
A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
This study is testing how well patients with moderate to severe rheumatoid arthritis stick with a new medication called Tyenne over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fresenius Kabi SwissBioSim GmbH Industry-sponsored |
| Drugs / interventions | tocilizumab |
| Locations | 8 sites (Berlin and 7 other locations) |
| Trial ID | NCT06247722 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world use of Tyenne, a biosimilar of tocilizumab, in patients diagnosed with moderate to severe rheumatoid arthritis. Over a 12-month period, the study will monitor patient persistence on Tyenne, specifically evaluating their ability to continue treatment at 6 and 12 months after initiation. Physicians will independently decide on prescribing Tyenne before patient enrollment, and participants will have one baseline visit followed by three follow-up visits. The study focuses on gathering data on treatment adherence in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with moderate to severe rheumatoid arthritis who are prescribed Tyenne by their physician.
Not a fit: Patients currently participating in interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and adherence to a biosimilar treatment option for rheumatoid arthritis patients.
How similar studies have performed: While this approach is observational, similar studies evaluating biosimilars have shown promising results in terms of treatment adherence and effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 7 other locations
- Rheumatologische Schwerpunktpraxis Berlin — Berlin, Germany (Recruiting)
- Rheumapraxis Dr. Liebhaber Halle — Halle, Germany (Recruiting)
- Facharztpraxis für Innere Medizin Ludwigsfelde — Ludwigsfelde, Germany (Recruiting)
- Rheumatologische Facharztpraxis — Magdeburg, Germany (Recruiting)
- Facharztpraxis für Innere Medizin — Naumburg, Germany (Recruiting)
- Klinische Forschung — Planegg, Germany (Recruiting)
- Rheumahaus Potsdam — Potsdam, Germany (Recruiting)
- Rheumatologische Facharztpraxis Templin — Templin, Germany (Recruiting)
Study contacts
- Study coordinator: Clinical Developement Director
- Email: medinfo_biosim@fresenius-kabi.com
- Phone: +41223076100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.