The Diagnostic Ultrasound Enthesitis Tool (DUET) Study
DUET
1 other identifier
observational
419
1 country
1
Brief Summary
Psoriatic arthritis (PsA) is a type of joint disease that can lead to severe joint damage and disability within the first few years of the disease. This is why early detection and treatment of the disease is essential to prevent serious joint damage and improve long-term outcomes in these patients. However, there is currently no reliable way to tell the difference between PsA and other types of joint disease. This makes it difficult to detect PsA early. Enthesitis is an inflammation of the area where muscle tendons and ligaments attach to bones. Enthesitis is a key feature in PsA and can be easily detected using ultrasonography. The aim of this research study is to develop a system to evaluate enthesitis using ultrasonography, which can be used as an effective tool in the early detection of PsA. This will help in providing patients with early treatment to prevent further joint damage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2023
CompletedMay 14, 2024
May 1, 2024
2 years
October 7, 2020
May 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
DUET scoring system for early diagnosis of PsA
To derive the DUET scoring system for distinguishing PsA from non-inflammatory disease using musculoskeletal ultrasound. The investigators will report the optimal set of weighted parameters and their performance measures (area under the curve, suggested cut-off points, sensitivity, and specificity).
From beginning to end of physical & ultrasound assessment, up to 1.5 hours
Secondary Outcomes (1)
Assess the construct validity of the new DUET scoring system
From beginning to end of physical & ultrasound assessment, up to 1.5 hours
Study Arms (3)
Psoriatic Arthritis
Subjects newly diagnosed with psoriatic arthritis (\< 5 years), confirmed by a rheumatologist and fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria.
Psoriasis without musculoskeletal symptoms
Patients with dermatologist confirmed psoriasis, without any history of Psoriatic Arthritis, and musculoskeletal symptoms.
Non-Inflammatory Rheumatic conditions
Patients with non-inflammatory rheumatic conditions such as osteoarthritis, non-specific back pain, soft tissue rheumatism, degenerative tendinopathy and fibromyalgia. Patients with present or past history of psoriasis, psoriatic arthritis, known or suspected rheumatic inflammatory conditions (e.g. rheumatoid arthritis, spondyloarthritis and gout), and/or inflammatory bowel disease will be excluded.
Interventions
High quality ultrasound scanners and high-resolution transducers, will be used to scan 16 joints sites for each subject. Ultrasound had excellent spatial resolution, making it an highly efficient, non-invasive tool for the assessment on enthesitis, which is an early feature of psoriatic arthritis. It is an affordable and accessible tool that is widely used in rheumatology practice.
Eligibility Criteria
Study subjects will be recruited form rheumatology and dermatology clinics at participating recruitment sites throughout the world.
You may qualify if:
- Age ≥18
- Able to provide an informed consent
- Meets the CASPAR criteria for PsA
- Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA
- Dermatologist confirmed diagnosis of psoriasis
- No prior diagnosis of PsA or signs of PsA on physical examination
- Psoriasis Epidemiology Screening Tool (PEST) score \< 3
- Referred to rheumatology for musculoskeletal symptoms such as joint pain, stiffness, back pain
- No evidence of inflammatory rheumatic condition including rheumatoid arthritis, spondyloarthritis, systemic lupus erythematosus, scleroderma, gout, septic arthritis or recent joint trauma/surgery
- No psoriasis
- No inflammatory bowel disease
You may not qualify if:
- Using any biologic medications including Tumor Necrosis Factor (TNF) inhibitors, Interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, Janus Kinase (JAK) inhibitors
- Prednisone ≥ 7.5 mg/day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women's College Hospital
Toronto, Ontario, M5S1B2, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lihi Eder, MD, PhD
University of Toronto
- PRINCIPAL INVESTIGATOR
Sibel Z Aydin, MD
University of Ottawa
- PRINCIPAL INVESTIGATOR
Gurjit S Kaeley, MD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2020
First Posted
October 14, 2020
Study Start
March 17, 2021
Primary Completion
February 27, 2023
Study Completion
February 27, 2023
Last Updated
May 14, 2024
Record last verified: 2024-05