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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03327454
Other study ID # GER-BNP-16-11103
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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