Trials / Completed
CompletedNCT04080661
Therapeutic Drug Monitoring of Secukinumab in Psoriasis Patients.
Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Secukinumab and the Development of a Concentration Response Curve of Secukinumab for Psoriasis Patients.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- University Hospital, Ghent · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Biologics such as secukinumab 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 secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.
Detailed description
Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of secukinumab (i.e. subcutaneous injections once a week for 5 weeks (300 mg) followed by subcutaneous injections every 4 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards secukinumab. 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 secukinumab. |
| OTHER | Patient questionnaires | The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit. |
Timeline
- Start date
- 2018-03-22
- 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 NCT04080661. Inclusion in this directory is not an endorsement.