Actively Recruiting
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
Led by SecondWave Systems Inc. · Updated on 2026-02-10
60
Participants Needed
5
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with active moderate to severe seropositive rheumatoid arthritis
- At least 6 tender and/or swollen joints on a 28 joint count at screening and Week 0
- Inadequate response or loss of response to standard csDMARDs or up to three bDMARDs/tsDMARDs
- Stable background csDMARD treatment prior to Week 0, with methotrexate stable for 4 weeks if used, others stable for 8 weeks
- Previous bDMARD or tsDMARD treatments stopped at least 4 weeks before Week 0 and not resumed until after Week 24
- Previous Golimumab or Infliximab stopped at least 8 weeks before Week 0 and not resumed until after Week 24
- Stable prednisone dose up to 10 mg daily for at least 6 weeks before Week 0, maintained through Week 24
- Torso circumference between 25 and 50 inches at belly button and sternum
- Willing to turn off immunomodulation device 4 weeks before Week 0 and not resume until after Week 24
- Willing not to start new immune modulating treatments during study and stabilize existing ones by Week 0
- Willing and able to follow medication rules in the study's Medication Guide
You will not qualify if you...
- Active bacterial or viral infection
- Pregnant women or those trying to become pregnant
- Receiving active chemotherapy or immunotherapy for cancer within 30 days before enrollment
- More than three prior bDMARDs or tsDMARDs treatments
- Previous treatment with Rituximab
- Implanted device or solid object near the spleen that interferes with ultrasound
- History of asplenia, splenomegaly, or ascites
- Recent abdominal surgery
- Currently participating in another investigational drug or device study
- Open wounds or sores that hinder study procedures
- Unable to perform basic daily self-care such as feeding or dressing
- Unable or unwilling to attend scheduled visits and remote observation sessions
- Cannot speak English
- Any other medical reason deemed by investigators making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Arizona Arthritis and Rheumatology Associates P.C.
Glendale, Arizona, United States, 85306
Actively Recruiting
2
Medvin Clinical Research
Covina, California, United States, 91722
Actively Recruiting
3
Southland Arthritis & Osteoporosis Medical Center
Temecula, California, United States, 92592
Actively Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
D
Daniel Zachs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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