A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers

What this Trial Is About

Researchers are investigating personalized precision medicine for adults aged 18 to 75 with psoriasis or psoriatic arthritis. This multi-center randomized clinical trial compares a prescreen strategy-based biologics selection using immune cell biomarkers versus standard guideline-based biologics treatment. The study also explores cardiovascular biomarkers to understand disease impact and treatment effects. Participants are randomly assigned to one of two groups a strategic group where biologics are selected based on individual immune cell screening and biomarker scores, and a standard group receiving biologics per current guidelines without prescreening. Biologics studied include adalimumab, etanercept, certolizumab pegol, golimumab, ustekinumab, secukinumab, ixekizumab, bimekizumab, and brodalumab. Blood samples are cultured to analyze cytokine responses, with follow-up visits scheduled at multiple intervals up to 72 weeks, extending up to 3 years if needed. Participants undergo clinical assessments including Psoriasis Area and Severity Index PASI, joint counts, Disease Activity in Psoriatic Arthritis DAPSA score, Dermatology Life Quality Index DLQI, and body surface area affected. Cardiovascular health is monitored by measuring internal carotid artery thickness at 6 months, 1 year, and 2 years. Researchers also collect data on pruritus and cytokine levels to evaluate treatment effects. Safety and efficacy outcomes are assessed regularly throughout the study period, with extended follow-up for up to 5 years.

A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers