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

StatusEnrolling by Invitation
PhaseNot specified
SponsorChao Ji
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion date: Nov 30, 2024 to Mar 25, 2025v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06686082
Lead Sponsor Chao Ji
Conditions
(from sponsor)
Subclinical Psoriatic Arthritis
Related terms Synovitis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov