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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07149792 on ClinicalTrials.gov