The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

NCT ID: NCT04587362

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 419 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2023-02-27

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.

Conditions

Psoriatic Arthritis; Psoriasis; Non-Inflammatory Rheumatic Conditions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Psoriatic Arthritis

Subjects newly diagnosed with psoriatic arthritis (\< 5 years), confirmed by a rheumatologist and fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria.

Musculoskeletal Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Musculoskeletal Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Musculoskeletal Ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥18
• Able to provide an informed consent

• Meets the CASPAR criteria for PsA
• Early PsA - Less than 5 years from a rheumatologist diagnosis of PsA

• Dermatologist confirmed diagnosis of psoriasis
• No prior diagnosis of PsA or signs of PsA on physical examination
• Psoriasis Epidemiology Screening Tool (PEST) score < 3

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis

NETWORK

Sponsor Role: collaborator

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lihi Eder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Sibel Z Aydin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa

Gurjit S Kaeley, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://pubmed.ncbi.nlm.nih.gov/32482769/

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

Other Identifiers

2019-0194-B

Identifier Type: -

Identifier Source: org_study_id