Arthritis, RheumatoidNCT03124225
Ultrasound Utility in Routine Clinical Practise
An observational study of Arthritis, Rheumatoid and Ultrasonography, run by Barts & The London NHS Trust.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Ultrasonography
- What is being tested?
- DMARD
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Early Arthritis patients
Who may be able to join
- Patients aged ≥18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis
Who cannot join
- 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
About this study
Official title: The Impact of Rheumatologist-performed Ultrasound on Diagnosis and Management of Inflammatory Arthritis in Routine Clinical Practice
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid, Ultrasonography
- Being tested
- DMARD
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMARDDrug
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Early Arthritis Patients seeing a Rheumatologist who uses US for assessment routinely in clinic Receives: Drug: DMARD | |
| Non-Ultrasound | Early Arthritis Patients seeing a Rheumatologist who does not uses US for assessment routinely in clinic Receives: Drug: DMARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startJun 2011
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124225
- Sponsor's protocol ID
- IMM 09-0270
- Status last verified
- Sep 2016
- First submitted
- 19 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Rheumatologist-performed Ultrasound on Diagnosis and Management of Inflammatory Arthritis in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03124225
- Acronym / sponsor ID
- IMM 09-0270
- Conditions
- Arthritis, Rheumatoid, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | Drug: DMARDEarly Arthritis Patients seeing a Rheumatologist who uses US for assessment routinely in clinic |
| Non-Ultrasound | – | Drug: DMARDEarly Arthritis Patients seeing a Rheumatologist who does not uses US for assessment routinely in clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Early Arthritis patients
Key inclusion criteria (1 listed)
- Patients aged ≥18 years at the time of presentation to the clinic Patients newly presenting to the rheumatology clinic with suspected inflammatory arthritis
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DMARD | Drug | Non-Ultrasound, Ultrasound |
Primary outcome
To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Ultrasonography, run by Barts & The London NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the time from first visit to treatment initiation between patients with and without rheumatologist-performed ultrasound assessment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.