The Diagnostic Ultrasound Enthesitis Tool (DUET) Study (DUET)

• ClinicalTrials.gov Identifier: NCT04587362
• Recruitment Status: Not yet recruiting
• First Posted: October 14, 2020
• Last Update Posted: December 10, 2020
• Sponsor: Women's College Hospital
• Collaborator: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)
• Information provided by (Responsible Party): Women's College Hospital

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• 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

More Information

Additional Information:

Development and Validation of a Sonographic Enthesitis Instrument in Psoriatic Arthritis: The GRAPPA Diagnostic Ultrasound Enthesitis Tool (DUET) Project 

• Responsible Party: Women's College Hospital
• ClinicalTrials.gov Identifier: NCT04587362
• Other Study ID Numbers: 2019-0194-B
• First Posted: October 14, 2020
• 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

Keywords provided by Women's College Hospital:

Enthesitis; PsA; Musculoskeletal Ultrasound; Diagnosis

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Psoriasis; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases