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

NCT ID: NCT06686082

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-03-25

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subclinical psoriatic arthritis patients

Biologics

Intervention Type: DRUG

The ultrasonic changes of synovitis and enthesitis were observed after 12 weeks of treatment with biologic agents

Interventions

Biologics

The ultrasonic changes of synovitis and enthesitis were observed after 12 weeks of treatment with biologic agents

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• diagnosed with moderate to severe plaque psoriasis
• no inflammatory arthritis manifestations
• Psoriasis Epidemic Severity Tool (PEST) score ≤ 2
• negative rheumatoid factor
• no prior use of any biologic treatments for psoriasis
• abnormal findings on musculoskeletal ultrasound screening

Exclusion Criteria

• a previous diagnosis of any other type of arthritis, including rheumatoid arthritis, osteoarthritis, gouty arthritis, ankylosing spondylitis, or similar conditions
• patients with contraindications to the use of biologics
• pregnant or breastfeeding women, and women of childbearing potential who do not agree to use contraception.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chao Ji

OTHER

Sponsor Role: lead

Responsible Party

Chao Ji

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Countries

China

Other Identifiers

FirstAHFujian666

Identifier Type: -

Identifier Source: org_study_id