drugset / Trial / NCT07149792

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

NCT07149792

RandomizedParallel-groupOpen-labelTreatment

Summary

The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded. A total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan. Participants were randomly assigned to one of two groups: Prescreen Strategy-Based Biologics Selection Group Standard-Based Biologics Selection Group Patients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary. Clinical assessments will include: Primary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score. Secondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.

Timeline

Start
2025-07-29
Primary completion
2026-12-31
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody
Subject Bimekizumab Monoclonal antibody
Subject Brodalumab Monoclonal antibody
Subject Certolizumab Pegol Protein / enzyme biologic 20 ug/ml
Subject Etanercept Protein / enzyme biologic
Subject Golimumab Monoclonal antibody 0.5 ug/ml
Subject Guselkumab Monoclonal antibody 1.2 ug/ml
Subject Ixekizumab Monoclonal antibody 3.5 ug/ml
Subject Risankizumab Monoclonal antibody 2 ug/ml
Subject Secukinumab Monoclonal antibody 16.7 ug/ml
Subject Secukinumab Monoclonal antibody 34 ug/ml
Subject Ustekinumab Monoclonal antibody 0.25 ug/ml