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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTaichung Veterans General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Prescreen platform

    Diagnostic test

    Different biomarkers on PsO, PsA and paradoxical PsA

  • biologics treatment

    Biological/Vaccine

    All psoriasis patients are receiving biologics treatment

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Prescreen Based bDMARD Stategic Treatment GroupExperimental treatment 2 interventions
Group B: Standard bDMARD Treatment GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From enrollment to the end of treatment at 48 weeks
2

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

Time frame
From enrollment to the end of treatment at 48 weeks

Secondary outcomes

1

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

Time frame
From enrollment to the end of treatment at 48 weeks
2

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

Time frame
From enrollment to the end of treatment at 48 weeks
3

Swelling joint counts

0 swollen joints = No active synovitis (remission or well-controlled disease) Higher counts = More active joint inflammation and more severe disease

Time frame
From enrollment to the end of treatment at 48 weeks
4

Tender joint counts

0 tender joints = No current joint pain (remission or well-controlled disease) Higher TJC = Greater disease burden or active joint inflammation

Time frame
From enrollment to the end of treatment at 48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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