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NCT03124225 Clinical Trial

Ultrasound Utility in Routine Clinical Practise

Arthritis, Rheumatoid Clinical Trial

Official title:
The Impact of Rheumatologist-performed Ultrasound on Diagnosis and Management of Inflammatory Arthritis in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03124225
Other study ID # IMM 09-0270
Secondary ID
Status Completed
Phase N/A
First received April 19, 2017
Last updated April 19, 2017
Start date June 2011
Est. completion date June 2013

Study information
Verified date September 2016
Source Barts & The London NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this research study is to describe the impact of rheumatologist performed ultrasound on the diagnosis and management pathways of patients with rheumatoid arthritis. Primarily, to compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment.

Description:

There are currently no guidelines for best practice in the use of ultrasound in RA and interim results from a survey by the British Society of Rheumatology (BSR) in this area have suggested that practice is variable across the UK. NICE recognize that the earlier persistent synovitis is identified and treated with disease modifying anti-rheumatic drugs DMARDs, the better the long term outcome and have welcomed the need to determine the role of imaging in assisting with this early diagnosis, and whether the added cost is justified by better disease outcomes.

This is a multi-site prospective observational study which investigates the use of ultrasound imaging in the context of patients with early arthritis presenting to secondary care. The time to commencement of DMARD therapy and diagnosis of Rheumatoid arthritis are therein outcome measures. Patients are followed up for 12 months after their first presentation and time to diagnosis or DMARD commencement recorded.

Recruitment information / eligibility
Status Completed
Enrollment 258
Est. completion date June 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients aged =18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis

Exclusion Criteria:

- For the non-ultrasound arm; patients who have been referred to another rheumatologist or radiologist for ultrasound Patients who decline or who are unable to consent to the use of their medical records for research

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DMARD

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Barts & The London NHS Trust

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment 12 months
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