Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (BENEFIT)

February 3, 2021 updated by: Biogen

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
585

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • München, Bavaria, Germany, 80639
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital

Description

Key Inclusion Criteria:

  • 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:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
With RA
Participants with RA previously treated with Enbrel and transitioned to Benepali
Biological: Benepali
As specified in the treatment arm
Biological: Enbrel
As specified in the treatment arm
Other Names:
  • etanercept
With axSpA
Participants with axSpA previously treated with Enbrel and transitioned to Benepali
Biological: Benepali
As specified in the treatment arm
Biological: Enbrel
As specified in the treatment arm
Other Names:
  • etanercept

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from transition point in Disease Activity Score (DAS-28 score)
Time Frame: Approximately 3 months after the transition
Score of 28 joints examined
Approximately 3 months after the transition
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
Time Frame: Approximately 3 months after the transition
Mean BASDAI score
Approximately 3 months after the transition

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Score of 28 joints examined
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
Defined as DAS-28 score ≤ 3.2 or ≤ 2.6
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
Defined by an increase in DAS-28 of ≥ 1.2, and a minimum DAS score of 3.2
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
Improvement of ≥ 1.2 points in DAS-28 score data collected
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
Assessed using Visual Analogue Scale (VAS) over time
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
BASDAI score
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
(ASDAS-ESR ) or (CRP) score
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
Defined by an increase in ASDAS score of ≥1.1, and a minimum ASDAS score of 2.1
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
Safety surveillance
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
Assessed using Disease activity-VAS score
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
Assessed using PAIN-VAS score
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
Assessed using FATIGUE - VAS score
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
Assessed using the HAQ-DI score
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
Assessed using Pain - VAS score
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
Assessed using FATIGUE - VAS score
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
Assessed using the HAQ-DI score
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
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
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
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
At baseline and approximately 3 and 6 months after the transition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Samsung Bioepis Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EUR-BNP-16-11030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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