Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis : a Pragmatic, Multicentric, Randomised, Controlled Study
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults; aged 18 years or older
• Documented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist
• Patients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.
• The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures
Locations
Other Locations
Belgium
AZ Sint-Jan
RECRUITING
Bruges
UCL Saint-Luc
RECRUITING
Brussels
ULB Erasme
NOT_YET_RECRUITING
Brussels
UZ Brussel
NOT_YET_RECRUITING
Brussels
Grand Hôpital de Charleroi
NOT_YET_RECRUITING
Charleroi
AZ Alma
NOT_YET_RECRUITING
Eeklo
Dermatologiepraktijk huidziekten Geel
NOT_YET_RECRUITING
Geel
AZ Maria Middelares
RECRUITING
Ghent
UZ Gent
RECRUITING
Ghent
Clinique André Renard
RECRUITING
Herstal
Dermatologie Handelskaai
RECRUITING
Kortrijk
UZ Leuven
NOT_YET_RECRUITING
Leuven
Dermatologie Maldegem
RECRUITING
Maldegem
Contact Information
Primary
Jo Lambert, Prof
jo.lambert@uzgent.be
093322298
Backup
Rani Soenen, Dr.
rani.soenen@uzgent.be
093326541
Time Frame
Start Date:2024-12-20
Estimated Completion Date:2028-03-01
Participants
Target number of participants:210
Treatments
No_intervention: Standard dosing of biologics
Patients will receive biological therapy according to standard clinical practice. Secukinumab, ixekizumab and guselkumab will be administered according to standard dosing regimen. Adjustments in doses and intervals, or biological switch according to clinical parameters or at the physicians' discretion are considered as standard clinical practice.~Investigators will not have access to information on levels of the drug or antidrug antibodies and no decision tree will be provided to guide treatment adjustments.
Experimental: Proactive TDM based dosing
Stepwise treatment modifications based on drug levels: if the drug level is below/above the target the dose of the biologic will be increased/decreased by stepwise interval shortening/lengthening - first modified by 33% and then 50% increase or decrease. If the target is still not reached at the next study visit, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.~In case the dosing regimen shifts from dose increase to dose decrease or vice versa, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached.