The Diagnostic Ultrasound Enthesitis Tool (DUET) Study (DUET)
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ClinicalTrials.gov Identifier: NCT04587362 |
Recruitment Status :
Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : December 10, 2020
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Condition or disease | Intervention/treatment |
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Psoriatic Arthritis Psoriasis Non-Inflammatory Rheumatic Conditions | Diagnostic Test: Musculoskeletal Ultrasound |
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | The Diagnostic Ultrasound Enthesitis Tool (DUET) Study: Development of a Sonographic Enthesitis Score for Early Diagnosis of Psoriatic Arthritis |
Estimated Study Start Date : | January 2021 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | February 2023 |

Group/Cohort | Intervention/treatment |
---|---|
Psoriatic Arthritis
Subjects newly diagnosed with psoriatic arthritis (< 5 years), confirmed by a rheumatologist and fulfilling the CASPAR criteria.
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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. |
Psoriasis without musculoskeletal symptoms
Patients with dermatologist confirmed psoriasis, without any history of Psoriatic Arthritis, and musculoskeletal symptoms.
|
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. |
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
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. |
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
- 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 TNF inhibitors , IL-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, JAK inhibitors
- Prednisone ≥ 7.5 mg/day

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587362
Contact: Fahmeen J Afgani, MBBS | +1416-323-6400 ext 7319 | fahmeen.afgani@wchospital.ca |
Canada, Ontario | |
Women's College Hospital | |
Toronto, Ontario, Canada, M5S1B2 | |
Contact: Fahmeen J Afgani, MBBS 416-323-6400 ext 7319 fahmeen.afgani@wchospital.ca | |
Principal Investigator: Lihi Eder, MD, PhD |
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 |
Responsible Party: | Women's College Hospital |
ClinicalTrials.gov Identifier: | NCT04587362 |
Other Study ID Numbers: |
2019-0194-B |
First Posted: | October 14, 2020 Key Record Dates |
Last Update Posted: | December 10, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Enthesitis PsA Musculoskeletal Ultrasound Diagnosis |
Arthritis Arthritis, Psoriatic Psoriasis Joint Diseases Musculoskeletal Diseases Skin Diseases, Papulosquamous |
Skin Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases |