Yuflyma® (Adalimumab), Patient Experience After Switching

NCT05427942 | Unknown

• 1 other identifier: 2022-A00448-35
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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

  March 2023

Study Arms (2)

Switch from adalimumab originator

Drug: Adalimumab

Switch from adalimumab biosimilar 40 mg/0,8 mL

Drug: Adalimumab

Interventions

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)

Switch from adalimumab biosimilar 40 mg/0,8 mL; Switch from adalimumab originator

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

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.

You may qualify if:

• Have an email account
• Have a mobile phone number
• Able to understand and complete French-language questionnaires
• Are not opposed to participating in the study.
• Are covered by French National Health Insurance.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Celltrion HealthCare France: lead

Study Sites (2)

Private Practice - ES

Marseille, France

RECRUITING

Private practice GB

Toulouse, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39322802 DERIVED

Related Links

• eCRF platform

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Non-Radiographic Axial Spondyloarthritis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative; Personal Satisfaction

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Salim BENKHALIFA, Dr

CONTACT

+33 1 71 25 27 00; yumatter@sanoia.com

Study Design

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

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 22, 2022
• Study Start: June 3, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)