The Diagnostic Ultrasound Enthesitis Tool (DUET) Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & 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 - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04587362
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Women's College Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lihi Eder, MD, PhDSibel Z Aydin, MDGurjit S Kaeley, MD
Principal Investigator Affiliation University of TorontoUniversity of OttawaUniversity of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Not yet recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis, Psoriasis, Non-Inflammatory Rheumatic Conditions
Arms & Interventions

Arms

: Psoriatic Arthritis

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

: Psoriasis without musculoskeletal symptoms

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

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Women's College Hospital, Toronto, Ontario, Canada

Status

Address

Women's College Hospital

Toronto, Ontario, M5S1B2

Site Contact

Fahmeen J Afgani, MBBS

[email protected]

416-323-6400 #7319

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