Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel (BENEFIT)
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About
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.
Enrollment
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Volunteers
Inclusion and 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.
Trial design
585 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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