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

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: Completed
• Conditions: Rheumatoid Arthritis; Axial Spondyloarthritis
• Intervention / Treatment: Biological: Benepali; Biological: Enbrel

• Study Type: Observational
• Enrollment (Actual): 585

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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 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

Outcome Measure	Measure Description	Time Frame
Change from transition point in Disease Activity Score (DAS-28 score)	Score of 28 joints examined	Approximately 3 months after the transition
Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score	Mean BASDAI score	Approximately 3 months after the transition

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the DAS-28 score over time from the value obtained at the Transition Point	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	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	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	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	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	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	(ASDAS-ESR ) or (CRP) score	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	Approximately 3 and 6 months after the transition
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity	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	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	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	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	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	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	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	Assessed using the HAQ-DI score	Approximately 3 and 6 months after the transition
Number of Participants by Demographic Category		At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medical History		At baseline and approximately 3 and 6 months after the transition
Number of Participants by Disease Status		At baseline and approximately 3 and 6 months after the transition
Number of Participants by Relevant Medication Use		At baseline and approximately 3 and 6 months after the transition

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: Samsung Bioepis Co., Ltd.

Publications and helpful links

Helpful Links

• Manuscript description

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Observational; Enbrel; Benepali; Biosimilar; Etanercept
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; Arthritis; Arthritis, Rheumatoid; Spondylitis; Spondylarthritis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID 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