Axial Spondyloarthritis, Rheumatoid Arthritis
Conditions
Keywords
Observational, Biosimilar, Etanercept, Benepali, Enbrel
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.
Interventions
Sponsors
Samsung Bioepis Co., Ltd.
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from transition point in Disease Activity Score (DAS-28 score) | Approximately 3 months after the transition | Score of 28 joints examined |
| Change from transition point in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score | Approximately 3 months after the transition | Mean BASDAI score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with worsening disease over time following Transition Point | 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 |
| Proportion of participants with an improvement of ≥ 1.2 points in DAS-28 score from Transition Point | Approximately 3 and 6 months after the transition | Improvement of ≥ 1.2 points in DAS-28 score data collected |
| Change in the General Health Score (assessed using VAS) over time following transition point | Approximately 3 and 6 months after the transition | Assessed using Visual Analogue Scale (VAS) over time |
| Change in the BASDAI score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | BASDAI score |
| 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 | Approximately 3 and 6 months after the transition | (ASDAS-ESR ) or (CRP) score |
| Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity | Approximately 3 and 6 months after the transition | Safety surveillance |
| Change in Patient Global Assessment (PtGA)-Disease activity-VAS score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using Disease activity-VAS score |
| Change in Patient Global Assessment - Visual Analogue Scale (PGA PAIN-VAS) score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using PAIN-VAS score |
| Change in the DAS-28 score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Score of 28 joints examined |
| Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using the HAQ-DI score |
| Change in PAIN-VAS score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using Pain - VAS score |
| Change in FATIGUE -VAS score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using FATIGUE - VAS score |
| Change in HAQ-DI score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using the HAQ-DI score |
| 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 | — |
| Change in Patient PGA FATIGUE -VAS score over time from the value obtained at the Transition Point | Approximately 3 and 6 months after the transition | Assessed using FATIGUE - VAS score |
| Proportion of participants with low disease activity or remission over time following Transition Point | Approximately 3 and 6 months after the transition | Defined as DAS-28 score ≤ 3.2 or ≤ 2.6 |
Countries
Germany
Outcome results
None listed