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

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ClinicalTrials.gov Identifier: NCT03100734
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Samsung Bioepis Co., Ltd.
Information provided by (Responsible Party):
Biogen

Brief 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.

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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Axial Spondyloarthritis Biological: Benepali Biological: Enbrel

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Study Type : Observational
Actual Enrollment : 585 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Group/Cohort Intervention/treatment
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 Name: 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 Name: etanercept




Primary Outcome Measures :
  1. Change from transition point in Disease Activity Score (DAS-28 score) [ Time Frame: Approximately 3 months after the transition ]
    Score of 28 joints examined

  2. Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score [ Time Frame: Approximately 3 months after the transition ]
    Mean BASDAI score


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Number of Participants by Demographic Category [ Time Frame: At baseline and approximately 3 and 6 months after the transition ]
  18. Number of Participants by Relevant Medical History [ Time Frame: At baseline and approximately 3 and 6 months after the transition ]
  19. Number of Participants by Disease Status [ Time Frame: At baseline and approximately 3 and 6 months after the transition ]
  20. Number of Participants by Relevant Medication Use [ Time Frame: At baseline and approximately 3 and 6 months after the transition ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100734


Locations
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Germany
Research Site
München, Bavaria, Germany, 80639
Sponsors and Collaborators
Biogen
Samsung Bioepis Co., Ltd.
Investigators
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Study Director: Medical Director Biogen
Additional Information:
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03100734    
Other Study ID Numbers: EUR-BNP-16-11030
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021

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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
Keywords provided by Biogen:
Observational
Biosimilar
Etanercept
Benepali
Enbrel
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylitis
Spinal Diseases
Bone Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors