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Biosimilar arthritis drug under Real-World watch

NCT ID NCT06247722

Knowledge-focused Sponsor: Fresenius Kabi SwissBioSim GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 600 people with moderate to severe rheumatoid arthritis who are prescribed Tyenne, a biosimilar of tocilizumab. Researchers will track how long patients stay on the treatment over 12 months. The goal is to see how well the drug works in everyday medical practice, outside of controlled trial settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tyenne (tocilizumab biosimilar)
What this could lead to
If successful, this study could show that Tyenne works well in everyday use for rheumatoid arthritis, supporting its wider adoption.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Facharztpraxis für Innere Medizin

    Naumburg, 06618, Germany

  • Facharztpraxis für Innere Medizin Ludwigsfelde

    Ludwigsfelde, 14974, Germany

  • Klinische Forschung

    Planegg, 82152, Germany

  • Rheumahaus Potsdam

    Potsdam, 14467, Germany

  • Rheumapraxis Dr. Liebhaber Halle

    Halle, 06128, Germany

  • Rheumatologische Facharztpraxis

    Magdeburg, 39104, Germany

  • Rheumatologische Facharztpraxis Templin

    Templin, 17268, Germany

  • Rheumatologische Schwerpunktpraxis Berlin

    Berlin, 12161, Germany

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