Rheumatoid ArthritisYU-MATTERNCT05427942
Yuflyma® (Adalimumab), Patient Experience After Switching
An observational study of Rheumatoid Arthritis and Ankylosing Spondylarthritis, run by Celltrion HealthCare France at 2 sites in France.
Trial summary
Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2022to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Rheumatoid Arthritis (RA) * Ankylosing Spondylarthritis (AS) * Axial Spondyloarthritis with no signs of AS (AxSpa) * Psoriatic Arthritis (PsA) * Crohn's Disease (CD) * Ulcerative Colitis (UC) Participants are included by practising physicians.
Who may be able to join
- Adult (aged 18 or older at the time of inclusion) rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies : Rheumatoid Arthritis (RA) Ankylosing Spondylarthritis (AS) Axial Spondyloarthritis with no signs of AS (AxSpa) Psoriatic Arthritis (PsA) Crohn's Disease (CD) Ulcerative Colitis (UC)
- Stable and treated for at least 3 months prior to inclusion either with an adalimumab (ADA) biosimilar or originator adalimumab (40 mg dose injections only)
- For whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study)
- Able to initiate treatment within 4 weeks of inclusion
- Have an email account
- Have a mobile phone number
Show all 17Show fewer
- Able to understand and complete French-language questionnaires
- Are not opposed to participating in the study.
- Are covered by French National Health Insurance.
- Non inclusion Criteria:
- Patients meeting any of the following exclusion criteria will not be included in the study:
- Patients younger than 18 years old at the date of inclusion
- Patients treated with adalimumab for any other pathology than those specified in the inclusion criteria.
- Patients treated with adalimumab originator 80 mg.
- Patients under curatorship or guardianship or otherwise deprived of liberty
- Patients unable to understand and complete French-language questionnaires
- Pregnant women or women of childbearing potential with a desire of becoming pregnant concomitant to treatment with Yuflyma®.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Private Practice - ES
Marseille
E S
- Recruiting
Private practice GB
Toulouse
G B
About this study
Official title: YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study
Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. This is compounded by the fact that many switched patients are not trained on how to use the new injection device.
Specifically, some patients report a degraded experience with current adalimumab biosimilars (40mg/0.8mL) as compared to the originator: injections appear more painful and seem to cause more bruising. Indeed, treatment-related factors such as treatment volume or the presence of citrate have the potential to negatively impact patient experience and contribute to local reactions at or around the injection site, such as pain and swelling.
Read more
Yuflyma® (CT-P17 adalimumab), developed by Celltrion Inc., is a biosimilar of the anti-TNF treatment adalimumab, having obtained a marketing authorisation from the European Commission on 11th February 2021 (addressed to Celltrion Healthcare).
Yuflyma® is the first high-concentration adalimumab biosimilar (40mg/0.4mL) available in France, which makes the product similar to the currently available adalimumab originator formula in terms of drug concentration.
Studying patient experience over the course of a switch involves querying patients at the time of prescription, while they are still under the previous treatment, and for the following 3 months, during which they have been able to pick up their prescribed medication from a pharmacy and have started using the new treatment. Describing patient experience over the course of a switch from another adalimumab (originator or biosimilar) to Yuflyma® would contribute to identifying significant factors which contribute to patient experience and satisfaction.
Our primary objective is to assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab.
- Overall satisfaction with the injection (7-level likert) before initiation
- Overall satisfaction with the injection (7-level likert) 3 months after initiation
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
- Being tested
- Adalimumab
- Keywords
- CT-P17, Patient experience, Satisfaction, Biosimilar
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Non-Radiographic Axial Spondyloarthritis, Arthritis, Psoriatic, Crohn Disease, Colitis, Ulcerative, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Stable and treated for at least 3 months prior to inclusion either with an adalimumab biosimilar or originator adalimumab (40 mg dose injections only) and for whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study)
| Study group | Role | What they receive |
|---|---|---|
| Switch from adalimumab originator | Not described Receives: Drug: Adalimumab | |
| Switch from adalimumab biosimilar 40 mg/0,8 mL | Not described Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall satisfaction
Assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab.
- Overall satisfaction with the injection (7-level likert) before initiation
- Overall satisfaction with the injection (7-level likert) 3 months after initiation
Measured: March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start3 Jun 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltrion HealthCare France
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427942
- Sponsor's protocol ID
- 2022-A00448-35
- Acronym
- YU-MATTER
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gossec L, Bouguen G, Dellal A, Foulley L, Habauzit C, Benkhalifa S, Marotte H. Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study. Rheumatol Ther. 2026 Jun;13(3):645-658. doi: 10.1007/s40744-026-00840-7. Epub 2026 Mar 16.
PubMed 41838366Bouguen G, Gossec L, Abitbol V, Senbel E, Bonnaud G, Roblin X, Bouhnik Y, Nancey S, Mathieu N, Filippi J, Vuitton L, Nahon S, Dellal A, Denis A, Foulley L, Habauzit C, Benkhalifa S, Marotte H. Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study. BioDrugs. 2024 Nov;38(6):867-878. doi: 10.1007/s40259-024-00681-2. Epub 2024 Sep 25.
PubMed 39322802
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YUflyma® (Adalimumab), Patient Experience After Switching to adaliMumab biosimilAr High concenTration, Low Volume (40mg/0.4mL) (Yuflyma®) by Taking Patient pERception of Treatment Into Account: The YU-MATTER Study
- ClinicalTrials.gov ID
- NCT05427942
- Acronym / sponsor ID
- YU-MATTER / 2022-A00448-35
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
- Keywords
- CT-P17, Patient experience, Satisfaction, Biosimilar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Celltrion HealthCare FranceIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 22 Jun 2022 (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.
Patient preference and experience can impact patients' adherence and persistence regarding a treatment, especially when switching. A number of factors contribute to this, including their beliefs, fears, expectations, and overall knowledge. This is compounded by the fact that many switched patients are not trained on how to use the new injection device.
Specifically, some patients report a degraded experience with current adalimumab biosimilars (40mg/0.8mL) as compared to the originator: injections appear more painful and seem to cause more bruising. Indeed, treatment-related factors such as treatment volume or the presence of citrate have the potential to negatively impact patient experience and contribute to local reactions at or around the injection site, such as pain and swelling.
Yuflyma® (CT-P17 adalimumab), developed by Celltrion Inc., is a biosimilar of the anti-TNF treatment adalimumab, having obtained a marketing authorisation from the European Commission on 11th February 2021 (addressed to Celltrion Healthcare).
Yuflyma® is the first high-concentration adalimumab biosimilar (40mg/0.4mL) available in France, which makes the product similar to the currently available adalimumab originator formula in terms of drug concentration.
Studying patient experience over the course of a switch involves querying patients at the time of prescription, while they are still under the previous treatment, and for the following 3 months, during which they have been able to pick up their prescribed medication from a pharmacy and have started using the new treatment. Describing patient experience over the course of a switch from another adalimumab (originator or biosimilar) to Yuflyma® would contribute to identifying significant factors which contribute to patient experience and satisfaction.
Our primary objective is to assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab.
- Overall satisfaction with the injection (7-level likert) before initiation
- Overall satisfaction with the injection (7-level likert) 3 months after initiation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch from adalimumab originator | – | Drug: Adalimumab |
| Switch from adalimumab biosimilar 40 mg/0,8 mL | – | Drug: Adalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies: * Rheumatoid Arthritis (RA) * Ankylosing Spondylarthritis (AS) * Axial Spondyloarthritis with no signs of AS (AxSpa) * Psoriatic Arthritis (PsA) * Crohn's Disease (CD) * Ulcerative Colitis (UC) Participants are included by practising physicians.
Key inclusion criteria (17 listed)
- Adult (aged 18 or older at the time of inclusion) rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies : Rheumatoid Arthritis (RA) Ankylosing Spondylarthritis (AS) Axial Spondyloarthritis with no signs of AS (AxSpa) Psoriatic Arthritis (PsA) Crohn's Disease (CD) Ulcerative Colitis (UC)
- Stable and treated for at least 3 months prior to inclusion either with an adalimumab (ADA) biosimilar or originator adalimumab (40 mg dose injections only)
- For whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study)
- Able to initiate treatment within 4 weeks of inclusion
- Have an email account
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabStable and treated for at least 3 months prior to inclusion either with an adalimumab biosimilar or originator adalimumab (40 mg dose injections only) and for whom the treating physician has decided to switch to Yuflyma® (40 mg / 0.4 mL) on the day of their inclusion (decision independent from the study) | Drug | Switch from adalimumab biosimilar 40 mg/0,8 mL, Switch from adalimumab originator |
Primary outcome
Overall satisfaction
Time frame: March 2023
Assess patients' overall satisfaction with the injection after the switch to the high-concentration adalimumab biosimilar Yuflyma®, at 3 months following the initiation, compared to their experience with the previous adalimumab. * Overall satisfaction with the injection (7-level likert) before initiation * Overall satisfaction with the injection (7-level likert) 3 months after initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 41838366Gossec L, Bouguen G, Dellal A, Foulley L, Habauzit C, Benkhalifa S, Marotte H. Sex Differences in Treatment Expectations, Satisfaction and Tolerance After Switching to CT-P17, an Adalimumab Biosimilar: A Post Hoc Analysis of the YU-MATTER Study. Rheumatol Ther. 2026 Jun;13(3):645-658. doi: 10.1007/s40744-026-00840-7. Epub 2026 Mar 16.
- Derived from this study: PubMed 39322802Bouguen G, Gossec L, Abitbol V, Senbel E, Bonnaud G, Roblin X, Bouhnik Y, Nancey S, Mathieu N, Filippi J, Vuitton L, Nahon S, Dellal A, Denis A, Foulley L, Habauzit C, Benkhalifa S, Marotte H. Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study. BioDrugs. 2024 Nov;38(6):867-878. doi: 10.1007/s40259-024-00681-2. Epub 2024 Sep 25.
- eCRF platformLink provided by the sponsor.
- 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.
2 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 and Ankylosing Spondylarthritis, run by Celltrion HealthCare France at 2 sites in France.
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 17 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salim BENKHALIFA, Dr (+33 1 71 25 27 00, yumatter@sanoia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall satisfaction (time frame: March 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427942, which also lists 2 linked publications.
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 22 Jun 2022.