A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
NCT07149792 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-09-02
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.
Conditions
- Psoriasis
- Psoriasis Arthritis
- Biologics
Interventions
- DIAGNOSTIC_TEST
-
Prescreen platform
Different biomarkers on PsO, PsA and paradoxical PsA
- BIOLOGICAL
-
biologics treatment
All psoriasis patients are receiving biologics treatment
Sponsors & Collaborators
-
Chang Gung Memorial Hospital
collaborator OTHER -
Chung Shan Medical University
collaborator OTHER -
Far Eastern Memorial Hospital
collaborator OTHER -
China Medical University Hospital
collaborator OTHER -
Taichung Veterans General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-29
- Primary Completion
- 2026-12-31
- Completion
- 2028-06-01
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Taiwan
Study Locations
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