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Benepali® PEN Patient Satisfaction Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03327454
Recruitment Status : Completed
First Posted : October 31, 2017
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Spondyloarthropathies Biological: Benepali

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : June 21, 2018
Actual Study Completion Date : June 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
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 Name: Etanercept

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03327454

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

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Responsible Party: Biogen Identifier: NCT03327454     History of Changes
Other Study ID Numbers: GER-BNP-16-11103
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Biogen:
Ankylosing spondylitis
Axial spondyloarthritis
Benepali pen
Patient questionnaire
Pre-filled pen
Biological DMARDs
Antirheumatic drug
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors