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CompletedNCT04587362DUETUpdated May 14, 2024

The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

An observational study in Psoriatic Arthritis, Psoriasis and Non-Inflammatory Rheumatic Conditions, sponsored by Women's College Hospital. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Women's College Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
419
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Psoriatic Arthritis
  • Psoriasis
  • Non-Inflammatory Rheumatic Conditions

Keywords

  • Enthesitis
  • PsA
  • Musculoskeletal Ultrasound
  • Diagnosis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 419 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Women's College Hospital is the lead sponsor of 83 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study subjects will be recruited form rheumatology and dermatology clinics at participating recruitment sites throughout the world.

Eligibility criteria

General Inclusion Criteria:

  • Age ≥18
  • Able to provide an informed consent

Specific Inclusion Criteria for PsA:

  • Meets the CASPAR criteria for PsA
  • Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA

Specific Inclusion Criteria for Psoriasis:

  • Dermatologist confirmed diagnosis of psoriasis
  • No prior diagnosis of PsA or signs of PsA on physical examination
  • Psoriasis Epidemiology Screening Tool (PEST) score \< 3

Specific Inclusion Criteria for non-inflammatory rheumatic disease:

  • 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

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
419 participants (actual)
Patient registry
No

Groups and cohorts

  • Psoriatic Arthritis

    Subjects newly diagnosed with psoriatic arthritis (\< 5 years), confirmed by a rheumatologist and fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria.

    Diagnostic Test: Musculoskeletal Ultrasound

  • Psoriasis without musculoskeletal symptoms

    Patients with dermatologist confirmed psoriasis, without any history of Psoriatic Arthritis, and musculoskeletal symptoms.

    Diagnostic Test: Musculoskeletal Ultrasound

  • 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.

    Diagnostic Test: Musculoskeletal Ultrasound

Interventions

  • Diagnostic testMusculoskeletal Ultrasound

    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.

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What researchers measure

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).

    Time frame: 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

    Construct validity of the newly derived DUET scoring system will evaluate its correlation with clinical measures of disease activity (e.g. total enthesitis count, joint count) and patient reported outcomes. The investigators will evaluate the agreement between central and local readers using the new scoring system to evaluate its reliability among local readers using intra-class correlation coefficient.

    Time frame: From beginning to end of physical & ultrasound assessment, up to 1.5 hours

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Study locations

1 site
  • Women's College Hospital
    Toronto, Ontario M5S1B2, Canada
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04587362
Lead sponsor
Women's College Hospital
Collaborators
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
Responsible party
Sponsor
First posted
Oct 14, 2020
Start date
Mar 17, 2021
Primary completion
Feb 27, 2023
Completion
Feb 27, 2023
Last update
May 14, 2024

Study contacts

Lihi Eder, MD, PhD
principal investigator · University of Toronto
Sibel Z Aydin, MD
principal investigator · University of Ottawa
Gurjit S Kaeley, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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