Switching treatment from innovator etanercept (Enbrel) to etanercept biosimilar (Benepali) in patients with a rheumatic disease in daily clinical care.
Completed
- Conditions
- Rheumatic diseases BiosimilarPersistence
- Registration Number
- NL-OMON21708
- Lead Sponsor
- Sint Maartenskliniek Nijmegen
- Brief Summary
https://pubmed.ncbi.nlm.nih.gov/29609207/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 500
Inclusion Criteria
Switched from Enbrel to Benepali in daily clinical practice in the Sint Maartenskliniek
- Older than 18 years of age
Exclusion Criteria
None
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in 6-months treatment persistence rate between Benepali in the switch cohort and Enbrel in the historical cohort.
- Secondary Outcome Measures
Name Time Method - To compare persistence of treatment with Benepali at 6 months of follow-up between the patient group that was randomly asked to fill in questionnaires at baseline and the patient group that was not. <br /><br>- To compare initial beliefs about biosimilar treatment (measured with CEQ, SETS and BMQ) between patients and rheumatologists.<br /><br>- To compare efficacy (difference in mean DAS28-CRP (for RA and PsA) and mean BASDAI (for SpA) between baseline (before first biosimilar injection) and at 6 and 12 months of treatment.<br /><br>- To evaluate safety (adverse events (AEs) and serious adverse events (SAEs)) during the follow-up period. <br /><br>- To assess whether patients’ and rheumatologists’ characteristics and initial beliefs are associated with persistence of treatment with Benepali at 6 months of follow-up.<br>