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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• Healthy subjects

• Psoriasis patients

• Psoriatic arthritis patients

• Agree to provide a blood sample

Locations
Other Locations
Taiwan
Taichung Vertenans General Hospital
RECRUITING
Taichung
Taichung Veterans Hospital
NOT_YET_RECRUITING
Taichung
Contact Information
Primary
James Yen, MD PhD
vernayen@yahoo.com.tw
886-4-23592525
Time Frame
Start Date: 2025-07-29
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 50
Treatments
Experimental: Prescreen Based bDMARD Stategic Treatment Group
Strategic groups: This group patients prescreen to various biologics (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment
Active_comparator: Standard bDMARD Treatment Group
This group patients receive biologics treatment (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) according to present guideline without individuals immune cells screen.
Related Therapeutic Areas
Sponsors
Collaborators: Chung Shan Medical University, China Medical University Hospital, Chang Gung Memorial Hospital, Far Eastern Memorial Hospital
Leads: Taichung Veterans General Hospital

This content was sourced from clinicaltrials.gov