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Completed

NCT Number: NCT03100734

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Benepali

Biological

As specified in the treatment arm

Enbrel

Biological

As specified in the treatment arm

Other names: etanercept

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Collaborators

  • Samsung Bioepis Co., Ltd.

Registry information

Official study 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

Acronym: BENEFIT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 4, 2017
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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