The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

Women's College Hospital

Status: Completed

Conditions: Psoriasis; Non-Inflammatory Rheumatic Conditions; Psoriatic Arthritis

Treatments: Diagnostic Test: Musculoskeletal Ultrasound

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT04587362

2019-0194-B

Details and patient eligibility

About

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.

Enrollment: 419 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• 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

Trial design

419 participants in 3 patient groups

Psoriatic Arthritis

Description:

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

Treatment:

Diagnostic Test: Musculoskeletal Ultrasound

Psoriasis without musculoskeletal symptoms

Description:

Patients with dermatologist confirmed psoriasis, without any history of Psoriatic Arthritis, and musculoskeletal symptoms.

Treatment:

Diagnostic Test: Musculoskeletal Ultrasound

Non-Inflammatory Rheumatic conditions

Description:

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.

Treatment:

Diagnostic Test: Musculoskeletal Ultrasound