NCT06686082Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 10 Nov 2024
- Start date
- 1 Nov 2023
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Chao Ji
- Diseases
- Psoriatic arthritis
- NCT number
- NCT06686082
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Nov 2023 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- a previous diagnosis of any other type of arthritis, including rheumatoid arthritis, osteoarthritis, gouty arthritis, ankylosing spondylitis, or similar conditions
Other
- patients with contraindications to the use of biologics
- pregnant or breastfeeding women, and women of childbearing potential who do not agree to use contraception.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.