Yuflyma® (Adalimumab), Patient Experience After Switching

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

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®.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celltrion HealthCare France
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Ankylosing Spondylarthritis, Axial Spondyloarthritis Without Radiographic Evidence of Ankylosing Spondylitis, Psoriatic Arthritis, Crohn Disease, Ulcerative Colitis
Study Website: View Trial Website
Arms & Interventions


: Switch from adalimumab originator

: Switch from adalimumab biosimilar 40 mg/0,8 mL


Drug: - Adalimumab

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)

Contact a Trial Team

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International Sites

Private Practice - ES, Marseille, France




Private Practice - ES

Marseille, ,

Private practice GB, Toulouse, France




Private practice GB

Toulouse, ,

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