Benepali® PEN Patient Satisfaction Survey

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327454
• Other study ID #: GER-BNP-16-11103
• Status: Completed
• Start date: August 10, 2017
• Est. completion date: June 21, 2018

Study information

• Verified date: October 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylarthropathies
• Spondyloarthropathies

Intervention

Biological:
• Benepali
Administered as specified in the treatment arm.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

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