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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis, Axial Spondyloarthritis

Intervention / Treatment
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* Biological: Benepali
* Biological: Enbrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With RA<br>Participants with RA previously treated with Enbrel and transitioned to Benepali | Biological: Benepali<br>* As specified in the treatment arm<br>Biological: Enbrel<br>* As specified in the treatment arm<br>* Other names: etanercept;|
| With axSpA<br>Participants with axSpA previously treated with Enbrel and transitioned to Benepali | Biological: Benepali<br>* As specified in the treatment arm<br>Biological: Enbrel<br>* As specified in the treatment arm<br>* Other names: etanercept;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational, Biosimilar, Etanercept, Benepali, Enbrel