Actively Recruiting
At-Home Ultrasound Therapy to Treat Moderate to Severe Rheumatoid Arthritis in Adults
Led by SecondWave Systems Inc. · Updated on 2026-06-17
60
Participants Needed
5
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MINI system, a non-invasive ultrasound device designed to reduce inflammation by stimulating the spleen in adults with active, moderate to severe rheumatoid arthritis who have not responded well or are intolerant to conventional synthetic, biologic, or targeted synthetic DMARDs. The study aims to assess the devices performance compared to a sham control in a randomized, double-blinded design. At least 60 participants will be enrolled across multiple sites to better understand this treatment approach. Participants will be randomly assigned to one of three groups two active ultrasound stimulation groups using different treatment settings and one sham non-active stimulation group. Each participant will receive daily ultrasound stimulation of the spleen for 20 minutes. The initial 12-week period is followed by a one-way crossover where those in the sham group switch to active stimulation, with an additional 12-week follow-up to assess long-term effects. During the study, participants will continue their stable background treatment with conventional synthetic DMARDs. Researchers will monitor changes in disease activity using the DAS28-CRP score from baseline to 12 weeks, comparing active groups to the sham control. Participants will be observed for safety and treatment effects throughout the 28-week study period, including adherence to medication and ultrasound use, with regular assessments and follow-up visits.
CONDITIONS
Brief Title
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females ages 18 and above
- Active moderate to severe seropositive rheumatoid arthritis
- At least 6 tender and/or swollen joints on a 28 joint count during screening and Week 0
- Inadequate response or loss of response to standard csDMARD treatment or up to three bDMARDs and tsDMARDs
- Stable background treatment with csDMARDs prior to Week 0, with methotrexate stable for at least 4 weeks and other csDMARDs stable for at least 8 weeks
- Willingness to maintain background medication regimen throughout the 28-week study
- Discontinuation of bDMARDs or tsDMARDs at least 4 weeks before Week 0 and no resumption until after Week 24
- Discontinuation of Golimumab or Infliximab at least 8 weeks before Week 0 and no resumption until after Week 24
- Stable prednisone dose (up to 10 mg daily) for at least 6 weeks before Week 0 and willingness to maintain dose until after Week 24
- Torso circumference at belly button and sternum between 25 and 50 inches
- Willingness to turn off immunomodulation device at least 4 weeks before Week 0 and no resumption until after Week 24
- Willingness not to start new immune modulating treatments during study and stabilize existing treatments by Week 0
- Ability and willingness 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
- Active chemotherapy or immunotherapy for malignancy within 30 days prior to enrollment
- Received more than three bDMARDs and tsDMARDs
- Prior treatment with Rituximab monoclonal antibody
- Implanted device or solid object near the spleen that interferes with ultrasound
- History of asplenia, splenomegaly, or ascites
- Recent abdominal surgery
- Current participation in another investigational drug or device study
- Open wounds or sores interfering with study procedures
- Inability to perform minimal daily self-care activities
- Refusal or inability to attend scheduled on-site and at-home visits or remote video sessions
- Inability to speak English
- Any other clinical reasons deemed inappropriate by investigators
Research Team
D
Daniel Zachs
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