Ultrasound Efficacy in Moderate Rheumatoid Arthritis

NCT04662359 | Completed Results FDA Device

• 1 other identifier: 844254
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Treatment Recommendations

  This measure is assessed after ultrasound results are available (1-2 weeks after ultrasound is performed) based on provider survey

Study Arms (1)

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.

Diagnostic Test: Ultrasound Assessment

Interventions

Ultrasound Assessment DIAGNOSTIC_TEST

Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.

Ultrasound Assessment of Rheumatoid Arthritis Severity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Dr. Michael George
• Organization: University of Pennsylvania

michael.george@pennmedicine.upenn.edu

215-662-2454

Study Officials

• Michael George, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All patients will receive the ultrasound assessment, so there is no need for masking
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 10, 2020
• Study Start: March 3, 2021
• Primary Completion: November 22, 2022
• Study Completion: December 10, 2022
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)