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Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Brodalumab and the Development of Concentration-response Curve of Brodalumab of Psoriasis Patients.
Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium
University Hospital of Ghent
Ghent, Oost-Vlaanderen, Belgium
Private Practice Dermatology
Maldegem, Oost-Vlaanderen, Belgium
University Hospital
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan
Bruges, West-Vlaanderen, Belgium
AZ Delta Rembert
Torhout, West-Vlaanderen, Belgium
Start Date
December 14, 2018
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
September 19, 2024
100
ESTIMATED participants
Venapuncture
PROCEDURE
Patient questionnaires
OTHER
Lead Sponsor
University Hospital, Ghent
Collaborators
NCT04340076
NCT03507946
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05215561