BeNeFIT18562: Dosisreduktion von Biologika der neuen Generation (Interleukin-17- und Interleukin-23-Inhibitoren) bei Psoriasis: eine pragmatische, nicht unterlegene, multizentrische, randomisierte, kontrollierte Studie - BeNeBio-Studie

Trial Description
Title

Dose reduction of the new generation biologics (interleukin 17 and interleukin 23 inhibitors) in psoriasis: A pragmatic, multicentre, randomized, controlled, non-inferiority study  - BeNeBio study

Participants (P)

Patients treated with the newest generation of biologics (IL17 or IL23 inhibitors), with long-term stable low disease activity at a normal dose.

Intervention (I)

Dose reduction by interval prolongation in 2 steps to a maximum decrease of 50% of the original dose when disease activity (PASI) and quality of life index (DLQI) remain low

Control (C)

Usual care

Outcome (O)

Cumulative incidence of persistent flares (PASI> 5 for ≥ 3 months)

Trial Design

Open-label, multi-centric randomised study; patients are randomized (2:1) to dose reduction or continuation of usual care

Sample Size

244 patients

Trial duration

41 months (FPI to CSR)

Budget

1 609 339,15 € (798 919,85 € in BE)

Status

Open to recruitment

 

Trial team

Sponsor

Sponsor NL: Radboudmc, Nijmegen

Belgian Coordinating Centre: UZ Gent

Chief Investigator

NL: Prof Dr E de Jong

BE: Prof Dr J Lambert

Trial coordinator/PM

Lynda Grine

Universitair Ziekenhuis Gent

Dermatologie

Lynda.Grine@UZGENT.be

Sites

8 sites in Belgium and 9 sites in the Netherlands

External Partners

KU Leuven (analysis of drug levels and antibodies)

Dokumente
Protocol  
Report

Q2/2023

Publication

 

Referenzen

Clinicaltrials.gov: NCT04340076

Webpage: BeNeBio website

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