NCT06686082

A Real-World Study of Biologic Therapy for Subclinical Psoriatic Arthritis

Effectiveness of Biologics on Synovitis and Enthesitis Using Musculoskeletal Ultrasound Assessment in Subclinical Psoriatic Arthritis: a 12-week Observational Real-world Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Chao Ji · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Psoriatic arthritis (PsA) is one of the most common comorbidities in patients with psoriasis (PsO). Current research suggests that the progression from PsO to PsA can be divided into five stages of the disease: PsO, preclinical PsA, subclinical PsA, prodromal PsA, and clinical PsA. Subclinical PsA refers to psoriasis participants who do not exhibit any clinical symptoms of arthritis but show evidence of synovio-enthesitis on ultrasound (US). However, there is currently no definitive biomarker that can accurately predict the progression from PsO to PsA. Synovitis and enthesitis are considered important features of PsA. Musculoskeletal ultrasound, using B-mode ultrasound and power Doppler (PD), can visualize synovitis and enthesitis, allowing for the early detection of subclinical PsA, as confirmed by multiple studies. Biologics are currently widely used in the treatment of PsA, with current treatment interventions primarily focusing on patients already diagnosed with PsA. In this study, we conducted a rigorous screening process to identify potential subclinical PsA patients among those with moderate to severe psoriasis. We treated these subclinical PsA patients with biologics and used musculoskeletal ultrasound as a method of efficacy assessment to observe the improvement of synovitis and enthesitis in subclinical PsA patients after 12 weeks of treatment.

Conditions

• Subclinical Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Biologics	The ultrasonic changes of synovitis and enthesitis were observed after 12 weeks of treatment with biologic agents

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-30
• Completion: 2025-03-25
• First posted: 2024-11-13
• Last updated: 2025-03-25

Locations

1 site across 1 country: China