Therapeutic Drug Monitoring for Psoriasis Treatment
Proactive TDM Versus Standard Use of Biologics in Psoriasis
Recruiting
Phase 4Interventional Study
Psoriasis Vulgaris
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
210 (estimated)
Sponsor
University Hospital, Ghent · Other
Who this trial is looking for
This trial is looking for adults with psoriasis who have been using certain medications for at least 6 months. Participants will receive personalized dosing advice based on their blood drug levels to improve their treatment outcomes.
Are You a Good Fit for This Trial?
Must be takingsecukinumabixekizumabguselkumab
You may be able to join if
I am 18 years old or older
I have been diagnosed with psoriasis
I have been treated with secukinumab, ixekizumab, or guselkumab for at least 6 months
I will sign a consent form to participate
You may not be able to join if
My psoriasis is not the main reason for using a biologic
I am taking other immunosuppressants besides methotrexate or acitretin
I have severe health issues with a short life expectancy
I cannot follow the study protocol
I am planning a pregnancy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and highe…
Biologics are effective agents for the treatment of psoriasis. The newest generation of biologics block interleukin 17 and 23. Physicians always prescribe these drugs in a fixed dose, but this may lead to under- and overdosing in some patients. Underdosing may lead to inadequate response or loss of response over time. Overdosage, on the other hand, can lead to higher risk of side effects and higher costs for the healthcare system. In daily clinical practice, physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic. In this study, we want to rationalize these dose modifications and optimize dosing based on the drug concentrations, measured in the blood of the patient (i.e. therapeutic drug monitoring). Depending on the drug concentration, the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result. The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups: a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice. We will monitor if the clinical response and quality of life remains stable. With this study, we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety, lower healthcare expenses and higher patients' treatment satisfaction while striving for the best clinical response.
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Eligibility Criteria
Inclusion Criteria:
1. Adults; aged 18 years or older
2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard …
Inclusion Criteria:
1. Adults; aged 18 years or older
2. Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
3. Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.
4. The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures
Exclusion Criteria:
1. Another indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)
2. Concomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)
3. Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline
4. Presumed inability to follow the study protocol
5. Active pregnancy wish
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