Benepali® PEN Patient Satisfaction Survey

Study Overview
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Brief Summary
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The main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a standardised participant questionnaire. In addition, it is to be investigated whether differences exist in general participant satisfaction between participant groups who have undergone various prior treatment and/or have previous experience with application systems (participants new to the use of biologics, participants changing over from a prefilled injection or changing over from another pre-filled pen) and between participants of the various indication groups. Furthermore, the participants are to evaluate various aspects of using the Benepali® pre-filled pen based on their personal experience, such as e.g. handling, user-friendliness and features of the Benepali® pre-filled pen, as well as the effectiveness of the training on injection with the Benepali® pre-filled pen, based on participant satisfaction with the training received with the training pen and the evaluation of the training material received.

Official Title
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Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen

Conditions
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Rheumatoid Arthritis, Spondyloarthropathies

Intervention / Treatment
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* Biological: Benepali


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of moderate to severe active rheumatoid arthritis, severe active and progressive rheumatoid arthritis, active and progressive psoriatic arthritis, severe active ankylosing spondylitis, or severe non-radiographic axial spondyloarthritis Current treatment with the Benepali® pre-filled pen in accordance with prescribing information for at least 3 months beforehand The patient has signed a declaration of consent to take part in the study Key Exclusion Criteria: Patients who are receiving Benepali® for the treatment of moderate to severe plaque psoriasis Patients who exhibit contraindications in accordance with the prescribing information for Benepali® and therefore treatment with Benepali ® is not indicated NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benepali<br>Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice. | Biological: Benepali<br>* Administered as specified in the treatment arm.<br>* Other names: Etanercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants that are Very Satisfied (4) or Satisfied (3) with the Benepali Pre-Filled Pen | The Questionnaire is based on a 5-point Likert scale where 0 = very dissatisfied, 1 = dissatisfied, 2 = neither dissatisfied nor satisfied, 3 = satisfied, 4 = very satisfied. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants that Answered Questions on Their Personal Experience of Various Aspects of Using the Benepali Pre-Filled Pen with a (3) or (4) on a 5-point Likert Scale. | The questions comprise the areas of handling, user-friendliness and features of the Benepali® pre-filled pen, satisfaction compared with the previous application system and satisfaction with the training on injection with the training pen. 0 = worst rating, 4 = best rating. | Day 1 | 
| Percentage of Participants that Answered Yes in Terms of Satisfaction with Training Materials | The participants evaluated the training materials and answered yes or no to questions regarding the adequate effectiveness, clarity, and extent of information provided. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing spondylitis, Axial spondyloarthritis, Benepali pen, Etanercept, Patient questionnaire, Pre-filled pen, Biological DMARDs, Antirheumatic drug