Actively Recruiting
Using Ultrasound to Guide Treat-to-Target Treatment Decisions in Adults With Moderate to High Rheumatoid Arthritis
Led by Italian Society for Rheumatology · Updated on 2025-05-14
158
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate treatment strategies for patients with Rheumatoid Arthritis RA who have moderate or high disease activity despite being on certain medications for at least three months. The study compares two approaches to guide treatment decisions one based on clinical evaluation alone and the other combining clinical evaluation with ultrasound imaging of joints. The goal is to see if using ultrasound helps achieve low disease activity or remission by 24 weeks. Participants are randomly assigned to one of two groups. In the clinical decision group, patients receive a new course of biologic or targeted synthetic DMARDs, with adjustments made after 12 weeks if disease control is not achieved. In the ultrasound group, patients undergo ultrasound scans of 44 joints to detect inflammation, guiding treatment choices alongside clinical assessments. If inflammation is found, treatment continues or switches if not, pain therapy is adjusted. The study lasts up to 72 months in total, with each participant actively followed for 48 weeks, including 24 weeks of treatment strategy and 24 weeks of follow-up. During the study, patients will have multiple assessments including ultrasound examinations, clinical disease activity scoring, joint counts, pain and fatigue scales, laboratory tests, and quality of life questionnaires at various time points up to 48 weeks. Researchers will monitor disease activity, remission rates, treatment costs, and patient-reported outcomes to compare effectiveness of the two strategies. Safety and treatment decisions are overseen by investigators, with participant involvement throughout the active and follow-up phases.
CONDITIONS
Brief Title
Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
Research Team
C
Christian Dejaco, MD, PhD
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