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

Study acronym: SMILE
StatusRecruiting
PhasePhase 4
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07149792
Lead Sponsor Taichung Veterans General Hospital
Collaborators: Chang Gung Memorial Hospital, Chung Shan Medical University, Far Eastern Memorial Hospital, China Medical University Hospital
Conditions
(from sponsor)
Psoriasis, Psoriasis Arthritis, Biologics
Related terms Arthritis, Psoriatic, Psoriasis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov