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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
Sponsor:
Collaborator:
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
Information provided by (Responsible Party):
Women's College Hospital

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.

Condition or disease Intervention/treatment
Psoriatic Arthritis Psoriasis Non-Inflammatory Rheumatic Conditions Diagnostic Test: Musculoskeletal Ultrasound

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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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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

Information from the National Library of Medicine

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


Contacts
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Contact: Fahmeen J Afgani, MBBS +1416-323-6400 ext 7319 fahmeen.afgani@wchospital.ca

Locations
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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         
Sponsors and Collaborators
Women's College Hospital
Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
Investigators
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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
Additional Information:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's College Hospital:
Enthesitis
PsA
Musculoskeletal Ultrasound
Diagnosis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases