About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy subjects
Psoriasis patients
Psoriatic arthritis patients
Agree to provide a blood sample
Disqualifiers
A current history of cancer,
Recent hospitalization for infection or current antibiotic treatment
HIV infection.
Trial design
Parallel
Treatments tested in this trial
Prescreen platform
Diagnostic testDifferent biomarkers on PsO, PsA and paradoxical PsA
biologics treatment
Biological/VaccineAll psoriasis patients are receiving biologics treatment
Treatment groups
Trial outcomes
Primary outcomes
PASI (Psoriasis Area and Severity Index)
The skin condition of psoriasis patients is assessed using the PASI (Psoriasis Area and Severity Index), which ranges from 0 to 72, with higher scores indicating more severe disease
DAPSA Score - Disease Activity in Psoriatic Arthritis
DAPSA Formula (Total Score): DAPSA = TJC (68) \+ SJC (66) \+ Patient Global Assessment (0-10) \+ Patient Pain Assessment (0-10) \+ CRP (mg/dL) DAPSA=TJC (68)+SJC (66)+Patient Global Assessment (0-10)+Patient Pain Assessment (0-10)+CRP (mg/dL) Where: TJC = Tender Joint Count (out of 68 joints) SJC = Swollen Joint Count (out of 66 joints) Patient Global Assessment (PtGA) = Patient's rating of overall disease activity (0-10 scale) Pain VAS = Patient's self-reported pain (0-10 scale) CRP = C-reactive protein level (mg/dL) Interpreting DAPSA Scores: DAPSA Score and Disease Activity Level ≤4 Remission, \>4-14 Low disease activity, \>14-28 Moderate disease activity, \>28 High disease activity
Secondary outcomes
BSA (body surface area)
The severity of psoriatic disease can be assessed using the Body Surface Area (BSA) score, which ranges from 0 to 100%. A higher BSA score indicates more extensive and severe skin involvement
Pruritus score
The severity of psoriatic disease can be assessed using the pruritus score, which ranges from 0 to 10. A higher pruritus score indicates more severe skin involvement
Swelling joint counts
0 swollen joints = No active synovitis (remission or well-controlled disease) Higher counts = More active joint inflammation and more severe disease
Tender joint counts
0 tender joints = No current joint pain (remission or well-controlled disease) Higher TJC = Greater disease burden or active joint inflammation
Sponsors and contacts
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Taichung Veterans General Hospital
Lead sponsor
Chang Gung Memorial Hospital
Collaborator
Chung Shan Medical University
Collaborator
Far Eastern Memorial Hospital
Collaborator
China Medical University Hospital
Collaborator