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NCT Number: NCT04587362

The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

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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Key information

Conditions

Psoriatic Arthritis Arthritis Arthritis, Psoriatic Bone Diseases Disease Joint Diseases Musculoskeletal Diseases Non-Inflammatory Rheumatic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Women's College Hospital

Toronto, Ontario, M5S1B2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musculoskeletal ultrasound

Diagnostic Test

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.

Primary outcomes

  1. DUET scoring system for early diagnosis of PsA

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

    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).

Secondary outcomes

  1. Assess the construct validity of the new DUET scoring system

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

    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.

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Registry information

Official study title

The Diagnostic Ultrasound Enthesitis Tool (DUET) Study: Development of a Sonographic Enthesitis Score for Early Diagnosis of Psoriatic Arthritis

Acronym: DUET

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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