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Switching treatment from innovator etanercept (Enbrel) to etanercept biosimilar (Benepali) in patients with a rheumatic disease in daily clinical care.


- candidate number24490
- NTR NumberNTR5901
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jun-2016
- Secondary IDs2016-2612 Submitted to CMO: not WMO liable
- Public TitleSwitching treatment from innovator etanercept (Enbrel) to etanercept biosimilar (Benepali) in patients with a rheumatic disease in daily clinical care.
- Scientific TitleBIO-SPAN: BIOsimilar switch, Study on Persistence and role of Attribution and Nocebo
- ACRONYMBIO-SPAN
- hypothesisTo investigate patients’ and rheumatologists’ characteristics and initial beliefs as determinants of the 6-months persistence of treatment with a biosimilar.
- Healt Condition(s) or Problem(s) studiedRheumatic diseases, Biological, Biosimilar
- Inclusion criteria- Switched from Enbrel to Benepali in daily clinical practice in the Sint Maartenskliniek
- Older than 18 years of age
- Ability to read and communicate well in Dutch
- Informed consent
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 15-jun-2016
- planned closingdate1-dec-2017
- Target number of participants500
- InterventionsPatients who switch treatment from Enbrel to Benepali will be asked to participate in this study. At baseline, patient and rheumatologist characteristics will be collected. Half of the included patients will randomly be asked to fill in validated questionnaires before the administration of the first Benepali injection (CEQ, SETS, BMQ, ASES). Rheumatologists will be asked to fill in the adapted CEQ, SETS and BMQ and perform an Implicit Association Test. Data on efficacy and safety will be obtained during the outpatient clinical visits performed in usual care at baseline and after 6 and 12 months of follow-up.
- Primary outcomeTo assess whether patients’ and rheumatologists’ characteristics and initial beliefs are associated with persistence of treatment with Benepali at 6 months of follow-up.
- Secondary outcome- 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.
- To compare initial beliefs about biosimilar treatment (measured with CEQ, SETS and BMQ) between patients and rheumatologists.
- 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.
- To evaluate safety (adverse events (AEs) and serious adverse events (SAEs)) during the follow-up period.
- TimepointsData will be recorded at baseline and after 6 and 12 months (+/- 2 months) of treatment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. L. Tweehuysen
- CONTACT for SCIENTIFIC QUERIESDr. A.A. Broeder, den
- Sponsor/Initiator Sint Maartenskliniek Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryPossible determinants of the 6-months persistence of treatment with a biosimilar in patients with a rheumatic disease will be investigated. Secondary endpoints include efficacy and safety outcomes during the 1 year follow-up period.
- Main changes (audit trail)26-jun-2017-MT
Hypothesis:
To investigate patients’ and rheumatologists’ characteristics and initial beliefs as determinants of the 6-months persistence of treatment with a biosimilar.

Replaced by
To investigate the impact of an open label non-mandatory switching strategy from Enbrel to Benepali on drug survival, effectiveness and safety in a controlled cohort study of RA, PsA and SpA patients in daily practice.

Primary outcome:
To assess whether patients’ and rheumatologists’ characteristics and initial beliefs are associated with persistence of treatment with Benepali at 6 months of follow-up.

Replaced by
Difference in 6-months treatment persistence rate between Benepali in the switch cohort and Enbrel in the historical cohort.

NEW Secondary outcome:
To assess whether patients’ and rheumatologists’ characteristics and initial beliefs are associated with persistence of treatment with Benepali at 6 months of follow-up
- RECORD15-jun-2016 - 26-jun-2017


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