Actively Recruiting
A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
Led by Taichung Veterans General Hospital · Updated on 2025-09-02
50
Participants Needed
2
Research Sites
74 weeks
Total Duration
On this page
Sponsors
T
Taichung Veterans General Hospital
Lead Sponsor
C
Chang Gung Memorial Hospital
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 75 years
- Diagnosed with psoriasis
- Diagnosed with psoriatic arthritis
- Agree to provide a blood sample
You will not qualify if you...
- Current history of cancer
- Recent hospitalization for infection or current antibiotic treatment
- HIV infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive biologics treatment. Those in the strategic group undergo prescreening of immune cells with various biologics to select the most appropriate treatment based on biomarker analysis before starting treatment. The standard group receives biologics treatment according to current guidelines without individual immune cell screening.
Clinical assessments at Weeks 0, 2, 4, 12, 24, and 48; intima thickness assessments at Weeks 0 and 48
Duration - Up to 5 years
Participants are followed for extended outcome comparison up to 5 years after treatment to monitor disease activity and quality of life.
Periodic assessments for clinical outcomes
Trial Site Locations
Total: 2 locations
1
Taichung Veterans Hospital
Taichung, Taiwan, Taiwan, 407219
Not Yet Recruiting
2
Taichung Vertenans General Hospital
Taichung, Taiwan, Taiwan, 886
Actively Recruiting
Research Team
J
James Yen, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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