Clinical trial NCT04587362: The Diagnostic Ultrasound Enthesitis Tool (DUET) Study
Official title: The Diagnostic Ultrasound Enthesitis Tool (DUET) Study: Development of a Sonographic Enthesitis Score for Early Diagnosis of Psoriatic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriatic Arthritis
Psoriasis
Non-Inflammatory Rheumatic Conditions
Keywords: Enthesitis
PsA
Musculoskeletal Ultrasound
Diagnosis
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis
First posted: 2020-10-14
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be recruited form rheumatology and dermatology clinics at participating recruitment sites throughout the world.

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.


Eligibility 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

Primary outcomes:
measure: DUET scoring system for early diagnosis of PsA
timeFrame: From beginning to end of physical & ultrasound assessment, up to 1.5 hours
Secondary outcomes:
measure: Assess the construct validity of the new DUET scoring system
timeFrame: From beginning to end of physical & ultrasound assessment, up to 1.5 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Lihi Eder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa
name: Sibel Z Aydin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Gurjit S Kaeley, MD
role: PRINCIPAL_INVESTIGATOR
References: