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

BIO-SPAN: BIOsimilar switch, Study on Persistence and role of Attribution and Nocebo

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON21708

Enrollment

500

Registered

2016-06-15

Start date

2016-06-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic diseases Biosimilar Persistence

Interventions

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 patien

Eligibility

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Difference in 6-months treatment persistence rate between Benepali in the switch cohort and Enbrel in the historical cohort.	—

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

—

Contacts

Public ContactA.A. den Broeder

Sint Maartenskliniek

a.denbroeder@maartenskliniek.nl+31243659276

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)