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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT03100734
• Date of registration: 29/03/2017
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel BENEFIT
• Scientific 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
• Date of first enrolment: June 1, 2017
• Target sample size: 585
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03100734
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Axial Spondyloarthritis

Rheumatoid Arthritis

Intervention(s)

Biological: Enbrel

Biological: Benepali

Primary Outcome(s)

Change from transition point in Disease Activity Score (DAS-28 score) [Time Frame: 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]

Secondary Outcome(s)

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]

Number of Participants by Relevant Medical History [Time Frame: At baseline and 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]

Number of Participants by Demographic Category [Time Frame: At baseline and 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 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]

Proportion of participants with low disease activity or remission over time following 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]

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]

Number of Participants by Disease Status [Time Frame: At baseline and 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 Relevant Medication Use [Time Frame: At baseline and 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 PAIN-VAS 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]

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 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 the DAS-28 score over time from the value obtained at the Transition Point [Time Frame: Approximately 3 and 6 months after the transition]

Secondary ID(s)

EUR-BNP-16-11030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Samsung Bioepis Co., Ltd.