Clinical trial NCT04662359: Ultrasound Efficacy in Moderate Rheumatoid Arthritis
Official title: Ultrasound to Enhance Treat-to-Target in Rheumatoid Arthritis: A Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Ultrasound
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Low Synovitis Scores
timeFrame: The outcome is assessed at the time of ultrasound
Secondary outcomes:
measure: Treatment Recommendations
timeFrame: This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Perelman Center for Advanced Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael George, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: