NCT06580886

Brief Summary

The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

August 27, 2024

Last Update Submit

August 29, 2024

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritisImagingUltrasound

Outcome Measures

Primary Outcomes (1)

  • Intraarticular synovitis scoring

    After the imaging of all patients is completed, intraarticular synovitis scoring will be done based on the OMERACT definitions (scales of 0-3) as follows. Greyscale inflammatory (hypoechoic) synovial hyperplasia: Grade 0: no hypoechoic synovial hyperplasia Grade 1: minimal hypoechoic synovial hyperplasia (filling the angle between the periarticular bones, without bulging over the line linking tops of the bones) Grade 2: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones but without extension along the bone diaphysis Grade 3: hypoechoic synovial hyperplasia bulging over the line linking tops of the periarticular bones and with extension to at least one of the bone diaphysis

    6 months

Secondary Outcomes (4)

  • Intraarticular Doppler scoring

    6 months

  • Assessment of nail images

    6 months

  • Assessment of tendon images

    6 months

  • Assessment of entheses images

    6 months

Other Outcomes (1)

  • Adverse event

    6 months

Study Arms (1)

Psoriatic arthritis

Age ≥18, Meets the classification for psoriatic arthritis (CASPAR) criteria, Able to provide an informed consent, Having peripheral disease phenotype of PsA, At least one tender and swollen join on the day of US

Device: Ultrasound

Interventions

UltrasoundDEVICE

All patients having ultrasound with Clarius L15/L20 and GE logic E9/E10 in same visit.

Psoriatic arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who fulfilled the inclusion and exclusion criterion.

You may qualify if:

  • Age ≥18
  • Meets the classification for psoriatic arthritis (CASPAR) criteria
  • Able to provide an informed consent
  • Having peripheral disease phenotype of PsA
  • At least one tender and swollen join on the day of US

You may not qualify if:

  • Having isolated axial PsA
  • Being in MDA with no tender and swollen joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Women's College Research Institute

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sibel Z Aydin, Prof

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Lihi Eder, Prof

    Women's College Hospital

    PRINCIPAL INVESTIGATOR

  • Gurjit Kaeley, Prof

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 30, 2024

Study Start

January 16, 2023

Primary Completion

June 28, 2024

Study Completion

June 28, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Locations

CA(2)US(1)