The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

Psoriasis Clinical Trial

— DUET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587362
• Other study ID #: 2019-0194-B
• Status: Completed
• Start date: March 17, 2021
• Est. completion date: February 27, 2023

Study information

• Verified date: May 2024
• Source: Women's College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Non-Inflammatory Rheumatic Conditions
• Psoriasis
• Psoriatic Arthritis

Intervention

Diagnostic Test:
• Musculoskeletal 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.

Locations

Country	Name	City	State
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From beginning to end of physical & ultrasound assessment, up to 1.5 hours

External Links

•   Development and Validation of a Sonographic Enthesitis Instrument in Psoriatic Arthritis: The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Diagnostic Ultrasound Enthesitis Tool (DUET) Project