Benepali® PEN Patient Satisfaction Survey

Biogen

Status: Completed

Conditions: Spondyloarthropathies; Rheumatoid Arthritis

Treatments: Biological: Benepali

Study type: Observational

Funder types: Industry

Identifiers

NCT03327454

GER-BNP-16-11103

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

500 participants in 1 patient group

Benepali

Description:

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

Treatment:

Biological: Benepali