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The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04587362
Acronym
DUET
Enrollment
419
Registered
2020-10-14
Start date
2021-03-17
Completion date
2023-02-27
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis, Psoriasis, Non-Inflammatory Rheumatic Conditions

Keywords

Enthesitis, PsA, Musculoskeletal Ultrasound, Diagnosis

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.

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.

Sponsors

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
CollaboratorNETWORK
Women's College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
DUET scoring system for early diagnosis of PsAFrom beginning to end of physical & ultrasound assessment, up to 1.5 hoursTo 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

MeasureTime frameDescription
Assess the construct validity of the new DUET scoring systemFrom beginning to end of physical & ultrasound assessment, up to 1.5 hoursConstruct 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026