Yuflyma® (Adalimumab), Patient Experience After Switching

Brief Title

Yuflyma® (Adalimumab), Patient Experience After Switching

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

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
    



Study Type

Observational


Primary Outcome

Overall satisfaction


Condition

Rheumatoid Arthritis

Intervention

Adalimumab

Study Arms / Comparison Groups

 Switch from adalimumab originator
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

300

Start Date

June 3, 2022

Completion Date

March 1, 2023

Primary Completion Date

December 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  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®.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +33 1 71 25 27 00, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05427942

Organization ID

2022-A00448-35


Responsible Party

Sponsor

Study Sponsor

Celltrion HealthCare France


Study Sponsor

, , 


Verification Date

June 2022