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Evaluation of the Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.
Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and 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, East-Flanders, Belgium
AZ Sint-Lucas
Ghent, East-Flanders, Belgium
University Hospital Ghent
Ghent, East-Flanders, Belgium
Private practice Dermatology
Maldegem, East-Flanders, Belgium
University Hospital
Leuven, Vlaams-Brabant, Belgium
AZ Sint-Jan
Bruges, West-Flanders, Belgium
AZ Delta Rembert
Torhout, West-Flanders, Belgium
Start Date
June 27, 2018
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
September 19, 2024
79
ACTUAL participants
Venapuncture
PROCEDURE
Patient questionnaires
OTHER
Lead Sponsor
University Hospital, Ghent
Collaborators
NCT04080635
NCT04340076
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 ConditionsNCT03507946