Trials / Completed
CompletedNCT04080648
Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients
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.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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.
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Venapuncture | Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab. |
| OTHER | Patient questionnaires | The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit |
Timeline
- Start date
- 2018-06-27
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2019-09-06
- Last updated
- 2024-09-19
Locations
7 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04080648. Inclusion in this directory is not an endorsement.