Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study
- Conditions
- Psoriasis (plaque psoriasis)
- Registration Number
- NL-OMON29024
- Lead Sponsor
- ZonMw, KCE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 244
•Plaque psoriasis (primarily)
•Treatment for 6 months at least with IL23 or IL17 inhibitor in a normal dose (dose advised by the label)
•PASI= 5 at inclusion and in previous 6 months (in previous 6 months, it should be clear from the patient record that psoriasis was clear/almost clear if no PASI scores are available).
•DLQI = 5 at inclusion
•Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication).
•Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc).
•Severe comorbidities with short life-expectancy (e.g. metastasized tumour).
•Presumed inability to follow the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative incidence of persistent flares (PASI> 5 for = 3 months)
- Secondary Outcome Measures
Name Time Method The percentage of successful dose reductions, the course of disease activity (PASI), incidence of short disease flares (PASI> 5 once), course of disease-related quality of life (DLQI), predictors for successful dose reduction, side effects, antibody formation and trough levels of biologics (PK), health-status (SF-36), quality-adjusted life-years (EQ-5D-5L), volumes of care (iMTA Medical Consumption Questionnaire), loss of productivity and presenteeism (Productivity Cost Questionnaire).