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Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study

Dose reduction of the new generation biologics (IL17 and IL23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study - BeNeBio study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON29024
Enrollment
244
Registered
2019-10-29
Start date
2019-12-01
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

Psoriasis (plaque psoriasis)

Interventions

Dose reduction strategy

Sponsors

ZonMw, KCE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of persistent flares (PASI> 5 for = 3 months)

Secondary

MeasureTime frame
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).

Contacts

Public ContactJuul van den Reek

Radboudumc

juul.vandenreek@radboudumc.nl0243617240

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)