Benepali® PEN Patient Satisfaction Survey

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Spondyloarthropathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Altenholz, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benepali

Biological

Administered as specified in the treatment arm.

Other names: Etanercept

Primary outcomes

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 outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Oct 31, 2017
Registry last updated: Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed