By InvitationNot Applicable

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

China150 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 12 weeks

Trial details

NCT IDNCT06686082

SponsorChao Ji

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Subclinical Psoriatic Arthritis trials