Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel
NCT03100734 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 585
Last updated 2021-02-05
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.
Conditions
- Rheumatoid Arthritis
- Axial Spondyloarthritis
Interventions
- BIOLOGICAL
-
Benepali
As specified in the treatment arm
- BIOLOGICAL
-
Enbrel
As specified in the treatment arm
Sponsors & Collaborators
-
Samsung Bioepis Co., Ltd.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Medical Director · Biogen
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-01
- Primary Completion
- 2018-11-30
- Completion
- 2018-11-30
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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