Clinical trial NCT03100734: Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Axial Spondyloarthritis
Keywords: Observational
Biosimilar
Etanercept
Benepali
Enbrel
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Samsung Bioepis Co., Ltd.
First posted: 2017-04-04
Enrollment: 585
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants With Rheumatoid Arthritis or Axial Spondyloarthritis to be identified from Primary Care Practice / Hospital

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.


Eligibility 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.

Primary outcomes:
measure: Change from transition point in Disease Activity Score (DAS-28 score)
timeFrame: Approximately 3 months after the transition
measure: Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
timeFrame: Approximately 3 months after the transition
Secondary outcomes:
measure: Change in the DAS-28 score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Proportion of participants with low disease activity or remission over time following Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Proportion of participants with worsening disease over time following Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in the General Health Score (assessed using VAS) over time following transition point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in the BASDAI score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: 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
timeFrame: Approximately 3 and 6 months after the transition
measure: Proportion of participants with worsening disease over time following Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in PAIN-VAS score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in FATIGUE -VAS score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Change in HAQ-DI score over time from the value obtained at the Transition Point
timeFrame: Approximately 3 and 6 months after the transition
measure: Number of Participants by Demographic Category
timeFrame: At baseline and approximately 3 and 6 months after the transition
measure: Number of Participants by Relevant Medical History
timeFrame: At baseline and approximately 3 and 6 months after the transition
measure: Number of Participants by Disease Status
timeFrame: At baseline and approximately 3 and 6 months after the transition
measure: Number of Participants by Relevant Medication Use
timeFrame: At baseline and approximately 3 and 6 months after the transition
Other outcomes:
Locations:
city: München
country: Germany
facility: Research Site
state: Bavaria
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: