Rheumatoid ArthritisBENEFITNCT03100734
Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
An observational study of Rheumatoid Arthritis and Axial Spondyloarthritis, run by Biogen at 1 site in Germany.
Trial summary
The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Axial Spondyloarthritis
- What is being tested?
- Benepali and Enbrel
- How many people
- 585 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 30 Nov 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 With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital
Who may be able to join
- Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice
- Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study
- Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period
- Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement
- Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy
Who cannot join
- Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:
- Hypersensitivity to the Benepali active substance, or to any of the associated excipients
- Sepsis, or risk of sepsis
- Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment
- Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator
- Treatment with another biologic agent
Show all 11Show fewer
- Are currently receiving or have previously received any therapies that would preclude administration of Benepali, such as the following:
- Immunizations with live or live-attenuated vaccines within the last 6 months prior to transition point and throughout the observation period
- Treatment with investigational agents within the last 6 months prior to transition point and during the period of observation.
- Any other unspecified reasons that would, in the opinion of the Investigator, make the patient unsuitable for enrollment.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study
The primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.
The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.
- Conditions
- Rheumatoid Arthritis, Axial Spondyloarthritis
- Being tested
- Benepali, Enbrel
- Keywords
- Observational, Biosimilar, Etanercept, Benepali, Enbrel
- Medical subject headings
- Arthritis, Rheumatoid, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenepaliBiological
As specified in the treatment arm
EnbrelBiological
Also called etanercept
As specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| With RA | Participants with RA previously treated with Enbrel and transitioned to Benepali Receives: Biological: Benepali; Biological: Enbrel | |
| With axSpA | Participants with axSpA previously treated with Enbrel and transitioned to Benepali Receives: Biological: Benepali; Biological: Enbrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from transition point in Disease Activity Score (DAS-28 score)
Score of 28 joints examined
Measured: Approximately 3 months after the transition
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
Mean BASDAI score
Measured: Approximately 3 months after the transition
Secondary outcomes (20)
Change in the DAS-28 score over time from the value obtained at the Transition Point
Score of 28 joints examined
Measured: Approximately 3 and 6 months after the transition
Proportion of participants with low disease activity or remission over time following Transition Point
Defined as DAS-28 score ≤ 3.2 or ≤ 2.6
Measured: Approximately 3 and 6 months after the transition
Proportion of participants with worsening disease over time following Transition Point
Defined by an increase in DAS-28 of ≥ 1.2, and a minimum DAS score of 3.2
Measured: Approximately 3 and 6 months after the transition
Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point
Improvement of ≥ 1.2 points in DAS-28 score data collected
Measured: Approximately 3 and 6 months after the transition
Change in the General Health Score (assessed using VAS) over time following transition point
Assessed using Visual Analogue Scale (VAS) over time
Measured: Approximately 3 and 6 months after the transition
Change in the BASDAI score over time from the value obtained at the Transition Point
BASDAI score
Measured: Approximately 3 and 6 months after the transition
Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point
(ASDAS-ESR ) or (CRP) score
Measured: Approximately 3 and 6 months after the transition
Proportion of participants with worsening disease over time following Transition Point
Defined by an increase in ASDAS score of ≥1.1, and a minimum ASDAS score of 2.1
Measured: Approximately 3 and 6 months after the transition
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Safety surveillance
Measured: Approximately 3 and 6 months after the transition
Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point
Assessed using Disease activity-VAS score
Measured: Approximately 3 and 6 months after the transition
Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point
Assessed using PAIN-VAS score
Measured: Approximately 3 and 6 months after the transition
Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point
Assessed using FATIGUE - VAS score
Measured: Approximately 3 and 6 months after the transition
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point
Assessed using the HAQ-DI score
Measured: Approximately 3 and 6 months after the transition
Change in PAIN-VAS score over time from the value obtained at the Transition Point
Assessed using Pain - VAS score
Measured: Approximately 3 and 6 months after the transition
Change in FATIGUE -VAS score over time from the value obtained at the Transition Point
Assessed using FATIGUE - VAS score
Measured: Approximately 3 and 6 months after the transition
Change in HAQ-DI score over time from the value obtained at the Transition Point
Assessed using the HAQ-DI score
Measured: Approximately 3 and 6 months after the transition
Number of Participants by Demographic Category
Measured: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medical History
Measured: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Disease Status
Measured: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medication Use
Measured: At baseline and approximately 3 and 6 months after the transition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jun 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Samsung Bioepis Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100734
- Sponsor's protocol ID
- EUR-BNP-16-11030
- Acronym
- BENEFIT
- Status last verified
- Feb 2021
- First submitted
- 29 Mar 2017
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Study to Evaluate the Real-Life Effectiveness of Benepali® Following Transition From Enbrel® in Patients With Rheumatoid Arthritis (RA) and Axial Spondyloarthritis (axSpA) - The BENEFIT Study
- ClinicalTrials.gov ID
- NCT03100734
- Acronym / sponsor ID
- BENEFIT / EUR-BNP-16-11030
- Conditions
- Rheumatoid Arthritis, Axial Spondyloarthritis
- Keywords
- Observational, Biosimilar, Etanercept, Benepali, Enbrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Samsung Bioepis Co., Ltd.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Apr 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 primary objective is to evaluate the effectiveness of Benepali in participants with Rheumatoid Arthritis (RA) and axial spondyloarthritis (axSpA), including participants with Ankylosing Spondylitis (AS) and non-radiographic axSpA, following their transition from treatment with Enbrel.
The secondary objectives of this study are to describe clinical characteristics of patients transitioned from Enbrel® to Benepali® in routine practice, to evaluate safety during and following the transition from Enbrel to Benepali and to evaluate patient-reported outcomes during and following the transition from Enbrel to Benepali.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With RA | – | Biological: Benepali, Biological: EnbrelParticipants with RA previously treated with Enbrel and transitioned to Benepali |
| With axSpA | – | Biological: Benepali, Biological: EnbrelParticipants with axSpA previously treated with Enbrel and transitioned to Benepali |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital
Key inclusion criteria (5 listed)
- Must have been diagnosed with either rheumatoid arthritis or axial spondyloarthritis, according to local practice
- Transition from Enbrel to Benepali at the physician's (Investigator's) discretion prior to enrolment into the study
- Must have been treated with the same dose of Enbrel for at least 6 months prior to transition to Benepali and have at least 1 efficacy data value including but not restricted to DAS-28 or BASDAI during that period
- Must have a stable disease throughout the 2 month prior to enrolment based on the Investigator's judgement
- Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy
Key exclusion criteria (11 listed)
- Have any medical conditions that precludes administration of Benepali according to Summary of Product Characteristics (SmPC), such as the following:
- Hypersensitivity to the Benepali active substance, or to any of the associated excipients
- Sepsis, or risk of sepsis
- Active clinically significant local or chronic viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 2 months prior to enrollment
- Show any clinical sign or medical condition not allowing for treatment continuation (of etanercept) in the judgment of the Investigator
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 |
|---|---|---|
| BenepaliAs specified in the treatment arm | Biological | With RA, With axSpA |
| EnbrelAlso: etanerceptAs specified in the treatment arm | Biological | With RA, With axSpA |
Primary outcome
Change from transition point in Disease Activity Score (DAS-28 score)
Time frame: Approximately 3 months after the transition
Score of 28 joints examined
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
Time frame: Approximately 3 months after the transition
Mean BASDAI score
20 secondary outcomes
Change in the DAS-28 score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Proportion of participants with low disease activity or remission over time following Transition Point
Time frame: Approximately 3 and 6 months after the transition
Proportion of participants with worsening disease over time following Transition Point
Time frame: Approximately 3 and 6 months after the transition
Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in the General Health Score (assessed using VAS) over time following transition point
Time frame: Approximately 3 and 6 months after the transition
Change in the BASDAI score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate (ASDAS-ESR ) or C-Reactive Protein (CRP) score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Proportion of participants with worsening disease over time following Transition Point
Time frame: Approximately 3 and 6 months after the transition
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Time frame: Approximately 3 and 6 months after the transition
Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in PAIN-VAS score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in FATIGUE -VAS score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Change in HAQ-DI score over time from the value obtained at the Transition Point
Time frame: Approximately 3 and 6 months after the transition
Number of Participants by Demographic Category
Time frame: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medical History
Time frame: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Disease Status
Time frame: At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medication Use
Time frame: At baseline and approximately 3 and 6 months after the transition
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 5 Feb 2021.
- Manuscript descriptionLink provided by the sponsor.
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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
1 site 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 Axial Spondyloarthritis, run by Biogen at 1 site 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 5 inclusion and 11 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from transition point in Disease Activity Score (DAS-28 score) (time frame: Approximately 3 months after the transition). The study lists 2 primary outcomes in all. 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 5 Feb 2021.