No registrations found.
ID
Source
Brief title
Health condition
Rheumatic diseases
Biosimilar
Persistence
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in 6-months treatment persistence rate between Benepali in the switch cohort and Enbrel in the historical cohort.
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.
- To assess whether patients’ and rheumatologists’ characteristics and initial beliefs are associated with persistence of treatment with Benepali at 6 months of follow-up.
Background summary
Possible 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.
Study objective
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.
Study design
Data will be recorded at baseline and after 6 and 12 months (+/- 2 months) of treatment.
Intervention
Patients 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.
A.A. den Broeder
Nijmegen 6500GM
The Netherlands
+31243659276
a.denbroeder@maartenskliniek.nl
A.A. den Broeder
Nijmegen 6500GM
The Netherlands
+31243659276
a.denbroeder@maartenskliniek.nl
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 criteria
None
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5747 |
| NTR-old | NTR5901 |
| Other | Submitted to CMO: not WMO liable : 2016-2612 |