At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study] (NCT07163221)
🩺 Plain-English Summary (8th-Grade Level)
The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.
Who can join: Review the eligibility criteria below.
Location: Arizona Arthritis and Rheumatology Associates P.C. — Glendale, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Arizona Arthritis and Rheumatology Associates P.C. — Glendale, Arizona
- Medvin Clinical Research — Covina, California
- Southland Arthritis & Osteoporosis Medical Center — Temecula, California
- University of Colorado — Aurora, Colorado
- University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases — Minneapolis, Minnesota
📞 Contact the Study Coordinator
Phone: (612) 444-6264
Email: info@secondwaveus.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Rheumatoid Arthritis (RA)
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- Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis — Montreal, Quebec
- A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis — Anniston, Alabama
- A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic — San Francisco, California
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Explore by condition: All Rheumatoid Arthritis (RA) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.