Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Biogen
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen
Time Frame: 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 Outcomes
- 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)
- Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials(Day 1)