Rheumatoid ArthritisNCT04662359
Ultrasound Efficacy in Moderate Rheumatoid Arthritis
A study testing Ultrasound Assessment in people with Rheumatoid Arthritis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The objectives of this research study are to determine the frequency of low synovitis scores by ultrasound in patients with Rheumatoid Arthritis in moderate or high disease activity and to compare physician treatment recommendations for patients before versus after receiving ultrasound results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Ultrasound Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients must meet the American College of Rheumatology's 2010 criteria for rheumatoid arthritis. They must be undergoing treatment with a disease-modifying anti-rheumatic drug, and their Clinical Disease Activity Index (CDAI) must be greater than 10 while their swollen joint count must be less than or equal to two.
Who cannot join
- Patients with evidence of large joint (knee, hip, shoulder, elbow) disease activity, including warmth and swelling, and patients who have had a joint MRI or musculoskeletal ultrasound in the past 3 months will not be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Ultrasound to Enhance Treat-to-Target in Rheumatoid Arthritis: A Cross-sectional Study
The objectives of this research study are to determine the frequency of low synovitis scores by ultrasound in patients with Rheumatoid Arthritis in moderate or high disease activity and to compare physician treatment recommendations for patients before versus after receiving ultrasound results. Participants will answer questionnaires about their disease activity and complete a musculoskeletal ultrasound in accordance with the study procedures.
Read the detailed description
The purpose of this research study is to determine whether ultrasound technology can improve treatment decisions for patients with rheumatoid arthritis who have elevated disease activity scores. To do so, the investigators will be evaluating rheumatoid arthritis patients with moderate to high disease activity and how ultrasound scans can reveal any new information about the severity of their arthritis. Patients will answer questionnaires to gauge their disease activity as well as the depression, fatigue, and pain they experience as a result of their arthritis. The patients will then undergo an ultrasound examination to evaluate their synovitis levels, which will then be made available to their physician. Physicians will be asked about their disease activity assessments and treatment recommendations before and after ultrasounds are performed.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Ultrasound Assessment
- Keywords
- Ultrasound
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound AssessmentDiagnostic test
Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Assessment of Rheumatoid Arthritis Severity | Other | All patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. Receives: Diagnostic Test: Ultrasound Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Synovitis Scores
The primary outcome variable is the proportion of patients with low synovitis scores, which will be determined by the ultrasound assessment. These scores will also be compared to other measures of disease activity. The investigators will be using the EULAR-OMERACT (European League Against Rheumatism - Outcome Measures in Rheumatology) combined scoring system for grading synovitis in rheumatoid arthritis. Each joint is scored from 0-3 with higher scores indicating higher inflammatory activity. Patients with scores of 1 or below in all measured joints are considered to have low synovitis scores.
Measured: The outcome is assessed at the time of ultrasound
Secondary outcomes (1)
Treatment Recommendations
The secondary outcome will be the number of patients for which the ultrasound information changed the treatment recommendation of the clinical provider.
Measured: This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start3 Mar 2021
- Primary completion22 Nov 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-arm pilot interventional study will evaluate the potential for ultrasound to improve disease activity assessments for patients with rheumatoid arthritis with clinical scores indicating moderate or high disease activity. Patient facing measures including the Routine Assessment of Patient Index Data (RAPID)3 and the Clinical Disease Activity (CDAI) will be used to determine patient disease activity, as well as whether patients are eligible for the study. The investigators will also collect inflammatory marker levels (including C-reactive protein) and ultrasound assessment to determine severity of illness and for physicians to determine treatment recommendations. Additional patient information will be obtained via chart reviews, and providers will complete pre- and post-ultrasound assessments of the patients.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael George, MD, MSCE, University of Pennsylvania
- Investigators
- Michael George, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662359
- Sponsor's protocol ID
- 844254
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound to Enhance Treat-to-Target in Rheumatoid Arthritis: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04662359
- Acronym / sponsor ID
- 844254
- Conditions
- Rheumatoid Arthritis
- Keywords
- Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this research study are to determine the frequency of low synovitis scores by ultrasound in patients with Rheumatoid Arthritis in moderate or high disease activity and to compare physician treatment recommendations for patients before versus after receiving ultrasound results. Participants will answer questionnaires about their disease activity and complete a musculoskeletal ultrasound in accordance with the study procedures.
Detailed description
The purpose of this research study is to determine whether ultrasound technology can improve treatment decisions for patients with rheumatoid arthritis who have elevated disease activity scores. To do so, the investigators will be evaluating rheumatoid arthritis patients with moderate to high disease activity and how ultrasound scans can reveal any new information about the severity of their arthritis. Patients will answer questionnaires to gauge their disease activity as well as the depression, fatigue, and pain they experience as a result of their arthritis. The patients will then undergo an ultrasound examination to evaluate their synovitis levels, which will then be made available to their physician. Physicians will be asked about their disease activity assessments and treatment recommendations before and after ultrasounds are performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm pilot interventional study will evaluate the potential for ultrasound to improve disease activity assessments for patients with rheumatoid arthritis with clinical scores indicating moderate or high disease activity. Patient facing measures including the Routine Assessment of Patient Index Data (RAPID)3 and the Clinical Disease Activity (CDAI) will be used to determine patient disease activity, as well as whether patients are eligible for the study. The investigators will also collect inflammatory marker levels (including C-reactive protein) and ultrasound assessment to determine severity of illness and for physicians to determine treatment recommendations. Additional patient information will be obtained via chart reviews, and providers will complete pre- and post-ultrasound assessments of the patients.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Assessment of Rheumatoid Arthritis Severity | Other | Diagnostic Test: Ultrasound AssessmentAll patients will receive an ultrasound scan to assess the severity of their arthritis. This scan will then be placed in their medical record to allow their rheumatologist to utilize the scan when making treatment recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must meet the American College of Rheumatology's 2010 criteria for rheumatoid arthritis. They must be undergoing treatment with a disease-modifying anti-rheumatic drug, and their Clinical Disease Activity Index (CDAI) must be greater than 10 while their swollen joint count must be less than or equal to two.
Key exclusion criteria (1 listed)
- Patients with evidence of large joint (knee, hip, shoulder, elbow) disease activity, including warmth and swelling, and patients who have had a joint MRI or musculoskeletal ultrasound in the past 3 months will not be eligible to participate in the study.
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 |
|---|---|---|
| Ultrasound AssessmentPatients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis. | Diagnostic test | Ultrasound Assessment of Rheumatoid Arthritis Severity |
Primary outcome
Low Synovitis Scores
Time frame: The outcome is assessed at the time of ultrasound
The primary outcome variable is the proportion of patients with low synovitis scores, which will be determined by the ultrasound assessment. These scores will also be compared to other measures of disease activity. The investigators will be using the EULAR-OMERACT (European League Against Rheumatism - Outcome Measures in Rheumatology) combined scoring system for grading synovitis in rheumatoid arthritis. Each joint is scored from 0-3 with higher scores indicating higher inflammatory activity. Patients with scores of 1 or below in all measured joints are considered to have low synovitis scores.
1 secondary outcome
Treatment Recommendations
Time frame: This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael George, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Assessment in people with Rheumatoid Arthritis, run by University of Pennsylvania at 1 site in United States.
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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Low Synovitis Scores (time frame: The outcome is assessed at the time of ultrasound). 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 16 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.