Status:

COMPLETED

Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

Lead Sponsor:

University Hospital, Ghent

Collaborating Sponsors:

KU Leuven

University Ghent

Conditions:

Psoriasis Vulgaris

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

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 t...

Detailed Description

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 fol...

Eligibility Criteria

Inclusion

  • Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
  • Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion

  • Participants who have currently a predominant nonplaque form of psoriasis
  • Participants who are pregnant, nursing or planning a pregnancy
  • Participants who are unable or unwilling to undergo multiple venapunctures
  • Participants who are treated according to a different dosing schedule than standard dosing of guselkumab

Key Trial Info

Start Date :

June 27 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

79 Patients enrolled

Trial Details

Trial ID

NCT04080648

Start Date

June 27 2018

End Date

December 31 2023

Last Update

September 19 2024

Active Locations (7)

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Page 1 of 2 (7 locations)

1

AZ Maria Middelares

Ghent, East-Flanders, Belgium, 9000

2

AZ Sint-Lucas

Ghent, East-Flanders, Belgium, 9000

3

University Hospital Ghent

Ghent, East-Flanders, Belgium, 9000

4

Private practice Dermatology

Maldegem, East-Flanders, Belgium, 9990