Clinical trial NCT03327454: Benepali® PEN Patient Satisfaction Survey
Official title: Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Spondyloarthropathies
Keywords: Ankylosing spondylitis
Axial spondyloarthritis
Benepali pen
Etanercept
Patient questionnaire
Pre-filled pen
Biological DMARDs
Antirheumatic drug
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.

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.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen
timeFrame: Day 1
Secondary outcomes:
measure: 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.
timeFrame: Day 1
measure: Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials
timeFrame: Day 1
Other outcomes:
Locations:
city: Altenholz
country: Germany
facility: Research Site
city: Bad Neuenahr-Ahrweiler
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Ehringshausen
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Giessen
country: Germany
facility: Research Site
city: Göpping
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Jülich
country: Germany
facility: Research Site
city: Kronach
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Mansfeld
country: Germany
facility: Research Site
city: Mittelherwigsdorf
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Neuss
country: Germany
facility: Research Site
city: Norderstedt
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Offenberg
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Seesen
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Ulm
country: Germany
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: