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

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

Treatments tested in this trial

  • Prescreen platform
  • biologics treatment

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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