NCT04080648CompletedPhase 4
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.
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 79 (actual)
- First submitted
- 19 Jul 2019
- Start date
- 27 Jun 2018
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University Hospital, Ghent
- Diseases
- Psoriasis
- NCT number
- NCT04080648
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 79
- From 27 Jun 2018 to the primary completion date, 31 Dec 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| AZ Sint-Lucas Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| AZ Maria Middelares Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| University Hospital Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| University Hospital Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Private Practice Dermatology Coordinator of this site? Confirm its status | Maldegem | Belgium | Unknown status |
| AZ Delta Rembert Coordinator of this site? Confirm its status | Torhout | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.