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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch from adalimumab originator |
| ||
| Switch from adalimumab biosimilar 40 mg/0,8 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| March 2023 |
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Inclusion Criteria:
Non inclusion Criteria:
Patients meeting any of the following exclusion criteria will not be included in the study:
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Adult rheumatology or gastroenterology patients presenting a diagnosis for any of the following pathologies:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salim BENKHALIFA, Dr | Contact | +33 1 71 25 27 00 | yumatter@sanoia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice - ES | Recruiting | Marseille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41838366 | Derived | 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. | |
| 39322802 |
| Label | URL |
|---|---|
| eCRF platform | View source |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| D015535 | Arthritis, Psoriatic |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Private practice GB | Recruiting | Toulouse | France |
|
| Bouguen 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001519 | Behavior |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |