Rheumatoid ArthritisNCT03327454
Benepali® PEN Patient Satisfaction Survey
An observational study of Rheumatoid Arthritis and Spondyloarthropathies, run by Biogen at 38 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthropathies
- What is being tested?
- Benepali
- How many people
- 500 participants
- Where
- 38 sitesGermany
- Study dates
- 10 Aug 2017to 21 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
38 sites in 1 country.
38 sites in 1 country
Germany38 sites
Research Site
Altenholz, 24161
Research Site
Bad Neuenahr-Ahrweiler, 53474
Research Site
Berlin, 10117
Research Site
Berlin, 10719
Research Site
Berlin, 12435
Research Site
Berlin, 12555
Research Site
Berlin, 13055
Research Site
Berlin, 13353
Research Site
Braunschweig, 38100
Research Site
Coburg, 96450
Research Site
Cologne, 50825
Research Site
Dresden, 01109
Research Site
Düsseldorf, 40211
Research Site
Ehringshausen, 35630
Research Site
Erfurt, 99096
Research Site
Essen, 45326
Research Site
Giessen, 35392
Research Site
Göpping, 73033
Research Site
Halle, 06128
Research Site
Hamburg, 22767
Research Site
Homburg, 66424
Research Site
Jülich, 52428
Research Site
Kronach, 96317
Research Site
Leipzig, 04109
Research Site
Leipzig, 04129
Research Site
Ludwigshafen, 67069
Research Site
Magdeburg, 39104
Research Site
Mansfeld, 06343
Research Site
Mittelherwigsdorf, 02763
Research Site
München, 80639
Research Site
Neuss, 41462
Research Site
Norderstedt, 22844
Research Site
Nuremberg, 90443
Research Site
Offenberg, 77652
Research Site
Saarbrücken, 66111
Research Site
Seesen, 38723
Research Site
Tübingen, 72072
Research Site
Ulm, 89073
About this study
Official title: Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
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.
- Conditions
- Rheumatoid Arthritis, Spondyloarthropathies
- Being tested
- Benepali
- Keywords
- Ankylosing spondylitis, Axial spondyloarthritis, Benepali pen, Etanercept, Patient questionnaire, Pre-filled pen, Biological DMARDs, Antirheumatic drug
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthropathies, Spondylitis, Ankylosing, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenepaliBiological
Also called Etanercept
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Benepali | Treatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice. Receives: Biological: Benepali |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start10 Aug 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327454
- Sponsor's protocol ID
- GER-BNP-16-11103
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2017
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Observational Study on Patient Satisfaction With the Benepali® Pre-Filled Pen
- ClinicalTrials.gov ID
- NCT03327454
- Acronym / sponsor ID
- GER-BNP-16-11103
- Conditions
- Rheumatoid Arthritis, Spondyloarthropathies
- Keywords
- Ankylosing spondylitis, Axial spondyloarthritis, Benepali pen, Etanercept, Patient questionnaire, Pre-filled pen, Biological DMARDs, Antirheumatic drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benepali | – | Biological: BenepaliTreatment of participants with the Benepali pre-filled pen takes place in accordance with the prescribing information and standard medical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are treated by practitioners in Germany and who are eligible according to the inclusion/exclusion criteria.
Key inclusion criteria (3 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenepaliAlso: EtanerceptAdministered as specified in the treatment arm. | Biological | Benepali |
Primary outcome
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.
2 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
Percentage of Participants that Answered "Yes" in Terms of Satisfaction with Training Materials
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthropathies, run by Biogen at 38 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants that are "Very Satisfied (4)" or "Satisfied (3)" with the Benepali Pre-Filled Pen (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.