Benepali® PEN Patient Satisfaction Survey
Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
1 other identifier
observational
500
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Shorter than P25 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2017
CompletedFirst Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2018
CompletedOctober 23, 2018
October 1, 2018
11 months
October 11, 2017
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
Benepali
Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice.
Interventions
Eligibility Criteria
Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (38)
Research Site
Altenholz, 24161, Germany
Research Site
Bad Neuenahr-Ahrweiler, 53474, Germany
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 10719, Germany
Research Site
Berlin, 12435, Germany
Research Site
Berlin, 12555, Germany
Research Site
Berlin, 13055, Germany
Research Site
Berlin, 13353, Germany
Research Site
Braunschweig, 38100, Germany
Research Site
Coburg, 96450, Germany
Research Site
Cologne, 50825, Germany
Research Site
Dresden, 01109, Germany
Research Site
Düsseldorf, 40211, Germany
Research Site
Ehringshausen, 35630, Germany
Research Site
Erfurt, 99096, Germany
Research Site
Essen, 45326, Germany
Research Site
Giessen, 35392, Germany
Research Site
Göpping, 73033, Germany
Research Site
Halle, 06128, Germany
Research Site
Hamburg, 22767, Germany
Research Site
Homburg, 66424, Germany
Research Site
Jülich, 52428, Germany
Research Site
Kronach, 96317, Germany
Research Site
Leipzig, 04109, Germany
Research Site
Leipzig, 04129, Germany
Research Site
Ludwigshafen, 67069, Germany
Research Site
Magdeburg, 39104, Germany
Research Site
Mansfeld, 06343, Germany
Research Site
Mittelherwigsdorf, 02763, Germany
Research Site
München, 80639, Germany
Research Site
Neuss, 41462, Germany
Research Site
Norderstedt, 22844, Germany
Research Site
Nuremberg, 90443, Germany
Research Site
Offenberg, 77652, Germany
Research Site
Saarbrücken, 66111, Germany
Research Site
Seesen, 38723, Germany
Research Site
Tübingen, 72072, Germany
Research Site
Ulm, 89073, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2017
First Posted
October 31, 2017
Study Start
August 10, 2017
Primary Completion
June 21, 2018
Study Completion
June 21, 2018
Last Updated
October 23, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share