Rheumatoid Arthritis, Spondyloarthropathies
Conditions
Keywords
Ankylosing spondylitis, Axial spondyloarthritis, Benepali pen, Etanercept, Patient questionnaire, Pre-filled pen, Biological DMARDs, Antirheumatic drug
Brief summary
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.
Interventions
BIOLOGICALBenepali
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants that are Very Satisfied (4) or Satisfied (3) with the Benepali Pre-Filled Pen | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 | 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. |
| Percentage of Participants that Answered Yes in Terms of Satisfaction with Training Materials | Day 1 | The participants evaluated the training materials and answered yes or no to questions regarding the adequate effectiveness, clarity, and extent of information provided. |
Countries
Germany
Outcome results
None listed