- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03124225
Ultrasound Utility in Routine Clinical Practise
The Impact of Rheumatologist-performed Ultrasound on Diagnosis and Management of Inflammatory Arthritis in Routine Clinical Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ultrasound
Early Arthritis Patients seeing a Rheumatologist who uses US for assessment routinely in clinic
|
|
|
Non-Ultrasound
Early Arthritis Patients seeing a Rheumatologist who does not uses US for assessment routinely in clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMM 09-0270
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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