Rheumatoid ArthritisRUBYNCT06247722
Real World Use of Tocilizumab Biosimilar studY
An observational study of Rheumatoid Arthritis, run by Fresenius Kabi SwissBioSim GmbH at 8 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 600 participants
- Where
- 8 sitesGermany
- Study dates
- 5 Mar 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Rheumatologische Schwerpunktpraxis Berlin
Berlin, 12161
Rheumapraxis Dr. Liebhaber Halle
Halle, 06128
Facharztpraxis für Innere Medizin Ludwigsfelde
Ludwigsfelde, 14974
Rheumatologische Facharztpraxis
Magdeburg, 39104
Facharztpraxis für Innere Medizin
Naumburg, 06618
Klinische Forschung
Planegg, 82152
Rheumahaus Potsdam
Potsdam, 14467
Rheumatologische Facharztpraxis Templin
Templin, 17268
About this study
Official title: A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
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:
Read more
- 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
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after treatment start
Secondary outcomes (4)
Persistence of tocilizumab treatment 12 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 12 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.
Measured: 12 months after treatment start
Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12
Measured: 12 months after treatment start
Change from Baseline in Patient Global Assessment of Disease Activity at Month 12
Measured: 12 months after treatment start
Change from Baseline in Physician Global Assessment of Disease Activity at Month 12
Measured: 12 months after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start5 Mar 2024
- Primary completion5 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247722
- Sponsor's protocol ID
- TOCI-001-CNI
- Acronym
- RUBY
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Prospective, Non-interventional Study, to Assess Real World Use of a Tocilizumab Biosimilar in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT06247722
- Acronym / sponsor ID
- RUBY / TOCI-001-CNI
- Conditions
- Rheumatoid Arthritis
- Keywords
- tocilizumab, rheumatoid arthritis, persistence, real world use, biosimilar, biosimilar switch, Tyenne
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fresenius Kabi SwissBioSim GmbHIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients participating or expected to participate in any interventional clinical trial during their treatment with Tyenne, a tocilizumab biosimilar
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar
Time frame: 6 months after treatment start
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.
4 secondary outcomes
Persistence of tocilizumab treatment 12 months after treatment start with Tyenne, a tocilizumab biosimilar
Time frame: 12 months after treatment start
Change from Baseline in Disease Activity Score 28 (DAS28-ESR or DAS 28-CRP) at Month 12
Time frame: 12 months after treatment start
Change from Baseline in Patient Global Assessment of Disease Activity at Month 12
Time frame: 12 months after treatment start
Change from Baseline in Physician Global Assessment of Disease Activity at Month 12
Time frame: 12 months after treatment start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Fresenius Kabi SwissBioSim GmbH at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of tocilizumab treatment 6 months after treatment start with Tyenne, a tocilizumab biosimilar (time frame: 6 months after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.