Benepali® PEN Patient Satisfaction Survey

Completed

• Conditions: Rheumatoid Arthritis; Spondyloarthropathies
• Interventions: Biological: Benepali

• Registration Number: NCT03327454
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-10
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-26
• Study First Posted: 2017-10-31
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benepali	Benepali	Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen	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

Name	Time	Method
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	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.
Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials	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.

Trial Locations

Locations (1)

Research Site; 🇩🇪 Ulm, Germany