Benepali® PEN Patient Satisfaction Survey

October 22, 2018 updated by: Biogen

Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Altenholz, Germany, 24161
        • Research Site
      • Bad Neuenahr-Ahrweiler, Germany, 53474
        • Research Site
      • Berlin, Germany, 10117
        • Research Site
      • Berlin, Germany, 13055
        • Research Site
      • Berlin, Germany, 13353
        • Research Site
      • Berlin, Germany, 10719
        • Research Site
      • Berlin, Germany, 12435
        • Research Site
      • Berlin, Germany, 12555
        • Research Site
      • Braunschweig, Germany, 38100
        • Research Site
      • Coburg, Germany, 96450
        • Research Site
      • Dresden, Germany, 01109
        • Research Site
      • Düsseldorf, Germany, 40211
        • Research Site
      • Ehringshausen, Germany, 35630
        • Research Site
      • Erfurt, Germany, 99096
        • Research Site
      • Essen, Germany, 45326
        • Research Site
      • Giessen, Germany, 35392
        • Research Site
      • Göpping, Germany, 73033
        • Research Site
      • Halle, Germany, 06128
        • Research Site
      • Hamburg, Germany, 22767
        • Research Site
      • Homburg, Germany, 66424
        • Research Site
      • Jülich, Germany, 52428
        • Research Site
      • Kronach, Germany, 96317
        • Research Site
      • Köln, Germany, 50825
        • Research Site
      • Leipzig, Germany, 04109
        • Research Site
      • Leipzig, Germany, 04129
        • Research Site
      • Ludwigshafen, Germany, 67069
        • Research Site
      • Magdeburg, Germany, 39104
        • Research Site
      • Mansfeld, Germany, 06343
        • Research Site
      • Mittelherwigsdorf, Germany, 02763
        • Research Site
      • München, Germany, 80639
        • Research Site
      • Neuss, Germany, 41462
        • Research Site
      • Norderstedt, Germany, 22844
        • Research Site
      • Nürnberg, Germany, 90443
        • Research Site
      • Offenberg, Germany, 77652
        • Research Site
      • Saarbrücken, Germany, 66111
        • Research Site
      • Seesen, Germany, 38723
        • Research Site
      • Tübingen, Germany, 72072
        • Research Site
      • Ulm, Germany, 89073
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Benepali
Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice.
Biological: Benepali
Administered as specified in the treatment arm.
Other Names:
  • Etanercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
Day 1
Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials
Time Frame: 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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2017

Primary Completion (ACTUAL)

June 21, 2018

Study Completion (ACTUAL)

June 21, 2018

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (ACTUAL)

October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-BNP-16-11103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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