Rheumatoid Arthritis Clinical Trial
Official title:
Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
Verified date | October 2018 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | June 21, 2018 |
Est. primary completion date | June 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Altenholz | |
Germany | Research Site | Bad Neuenahr-Ahrweiler | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Braunschweig | |
Germany | Research Site | Coburg | |
Germany | Research Site | Dresden | |
Germany | Research Site | Düsseldorf | |
Germany | Research Site | Ehringshausen | |
Germany | Research Site | Erfurt | |
Germany | Research Site | Essen | |
Germany | Research Site | Giessen | |
Germany | Research Site | Göpping | |
Germany | Research Site | Halle | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Homburg | |
Germany | Research Site | Jülich | |
Germany | Research Site | Köln | |
Germany | Research Site | Kronach | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Leipzig | |
Germany | Research Site | Ludwigshafen | |
Germany | Research Site | Magdeburg | |
Germany | Research Site | Mansfeld | |
Germany | Research Site | Mittelherwigsdorf | |
Germany | Research Site | München | |
Germany | Research Site | Neuss | |
Germany | Research Site | Norderstedt | |
Germany | Research Site | Nürnberg | |
Germany | Research Site | Offenberg | |
Germany | Research Site | Saarbrücken | |
Germany | Research Site | Seesen | |
Germany | Research Site | Tübingen | |
Germany | Research Site | Ulm |
Lead Sponsor | Collaborator |
---|---|
Biogen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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