Clinical trial NCT06686082: A Real-World Study of Biologic Therapy for Subclinical Psoriatic Arthritis
Official title: Effectiveness of Biologics on Synovitis and Enthesitis Using Musculoskeletal Ultrasound Assessment in Subclinical Psoriatic Arthritis: a 12-week Observational Real-world Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Subclinical Psoriatic Arthritis
Keywords: synovitis
enthesitis
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Moderate-to-severe plaque psoriasis coming to our hospital

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.


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.

Primary outcomes:
measure: Improvement of synovitis and enthesitis after 12 weeks of treatment with biological agents.
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: FuZhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: