Real World Use of Tocilizumab Biosimilar studY

NCT06247722 | Active Not Recruiting

• 1 other identifier: TOCI-001-CNI
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

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.

Conditions

Rheumatoid Arthritis

Keywords

tocilizumab; rheumatoid arthritis; persistence; real world use; biosimilar; biosimilar switch; Tyenne

Outcome Measures

Primary Outcomes (1)

• Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar

  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.

  6 months after treatment start

Secondary Outcomes (4)

• Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar

  12 months after treatment start

• 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

• Change from Baseline in Physician Global Assessment of Disease Activity at Month 12

  12 months after treatment start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients initially diagnosed with moderate to severe rheumatoid arthritis (RA) according to ACR/EULAR 2010 rheumatoid arthritis classification criteria
• 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)

You may not qualify if:

• Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar

Sponsors & Collaborators

• Fresenius Kabi SwissBioSim GmbH: lead

Study Sites (8)

Rheumatologische Schwerpunktpraxis Berlin

Berlin, 12161, Germany

Location

Rheumapraxis Dr. Liebhaber Halle

Halle, 06128, Germany

Location

Facharztpraxis für Innere Medizin Ludwigsfelde

Ludwigsfelde, 14974, Germany

Location

Rheumatologische Facharztpraxis

Magdeburg, 39104, Germany

Location

Facharztpraxis für Innere Medizin

Naumburg, 06618, Germany

Location

Klinische Forschung

Planegg, 82152, Germany

Location

Rheumahaus Potsdam

Potsdam, 14467, Germany

Location

Rheumatologische Facharztpraxis Templin

Templin, 17268, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: March 5, 2024
• Primary Completion: March 5, 2026
• Study Completion: March 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8)