Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Psoriasis Vulgaris
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A prospective, open label, non-randomized studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in or...
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.
Tracking Information
- NCT #
- NCT04080648
- Collaborators
- KU Leuven
- University Ghent
- Investigators
- Principal Investigator: Jo Lambert, Prof. University Ghent
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