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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Assessment | Diagnostic Test | Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome is assessed at the time of ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Recommendations | The secondary outcome will be the number of patients for which the ultrasound information changed the treatment recommendation of the clinical provider. | This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael George, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Assessment of Rheumatoid Arthritis Severity | 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. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Assessment of Rheumatoid Arthritis Severity | 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. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | The outcome is assessed at the time of ultrasound |
|
Adverse events were collected from the time of enrollment through completion of ultrasound (within 3 months)
standard definitions used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound Assessment of Rheumatoid Arthritis Severity | 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. Ultrasound Assessment: Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael George | University of Pennsylvania | 215-662-2454 | michael.george@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 | Feb 1, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2021 | Dec 21, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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All patients will receive the ultrasound assessment, so there is no need for masking
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Rheumatoid arthritis disease duration | Mean | Standard Deviation | years |
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| Secondary | Treatment Recommendations | The secondary outcome will be the number of patients for which the ultrasound information changed the treatment recommendation of the clinical provider. | Posted | Count of Participants | Participants | This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |