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.
ID
Bron
Verkorte titel
Aandoening
Rheumatic diseases
Biosimilar
Persistence
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Difference in 6-months treatment persistence rate between Benepali in the switch cohort and Enbrel in the historical cohort.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Data will be recorded at baseline and after 6 and 12 months (+/- 2 months) of treatment.
Onderzoeksproduct en/of interventie
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.
Publiek
A.A. den Broeder
Nijmegen 6500GM
The Netherlands
+31243659276
a.denbroeder@maartenskliniek.nl
Wetenschappelijk
A.A. den Broeder
Nijmegen 6500GM
The Netherlands
+31243659276
a.denbroeder@maartenskliniek.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
None
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5747 |
NTR-old | NTR5901 |
Ander register | Submitted to CMO: not WMO liable : 2016-2612 |