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

NCT06686082 | Enrolling By Invitation DMC

• 1 other identifier: FirstAHFujian666
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

synovitis; enthesitis

Outcome Measures

Primary Outcomes (1)

• Improvement of synovitis and enthesitis after 12 weeks of treatment with biological agents.

  The assessment using ultrasound was performed at two time points: baseline (0 weeks) and 12 weeks after medication initiation. The joint examination sites were based on the PsAson22. The examination sites for enthesitis were based on the Leeds Enthesitis Index (LEI). According to the European League Against Rheumatism (EULAR)- the Outcome Measures in Rheumatology (OMERACT) definition, the 22 joints with synovitis were scored using ultrasound composite semi-quantitative scale. Additionally, the 6 sites of entheses were evaluated according to the OMERACT enthesitis composite semi-quantitative scale. When assessing joint synovitis and enthesitis using grey scale (GS) and power Doppler (PD), we take the higher score as the final score for that site (range 0 to 3). The total score is the sum of the scores for each site, ranging from 0 to 84. Assess the improvement of Sub-PsA patients by evaluating changes before and after treatment through the scoring of synovitis and enthesitis.

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

Subclinical psoriatic arthritis patients

Drug: Biologics

Interventions

Biologics DRUG

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

Subclinical psoriatic arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate-to-severe plaque psoriasis coming to our hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chao Ji: lead

Study Sites (1)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 35000000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subclinical psoriatic arthritis detected by musculoskeletal ultrasound in patients with moderate to severe plaque psoriasis.

MeSH Terms

Conditions

Synovitis

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 13, 2024
• Study Start: November 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: March 25, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)