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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the MINI system, a device that delivers ultrasound stimulation to the spleen, for treating adults with active, moderate to severe rheumatoid arthritis who have not responded well or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs csDMARDs, biologic DMARDs bDMARDs, or targeted synthetic DMARDs tsDMARDs. The study aims to assess whether this non-invasive treatment can reduce inflammation compared to a sham control. At least 60 participants will be enrolled across up to 8 sites in this randomized, quadruple-masked clinical trial. Participants will be randomly assigned to one of three groups two groups will receive daily non-invasive ultrasound stimulation of the spleen using different treatment settings, each for 20 minutes per day, and one group will receive a sham non-active ultrasound stimulation for the same duration. All participants will continue stable doses of at least one csDMARD throughout the study. After 12 weeks, those in the sham control group will crossover to active stimulation, followed by an additional 12-week follow-up to evaluate long-term effects. Throughout the study, participants will be assessed for changes in their rheumatoid arthritis disease activity using the DAS28-CRP score from baseline to 12 weeks, comparing active treatment arms to the sham control. Participants will also undergo regular monitoring to ensure adherence to the treatment regimen and stable background medication. The total study duration for participants is approximately 28 weeks, including initial treatment, crossover, and follow-up periods, with safety and outcome evaluations conducted throughout.
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 assessment at 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 a csDMARD prior to Week 0 and willingness to maintain it throughout the 28-week study
- Discontinued bDMARDs or tsDMARDs at least 4 weeks prior to Week 0 if previously treated, not resuming until after Week 24
- Discontinued Golimumab or Infliximab at least 8 weeks prior to Week 0 if previously treated, not resuming until after Week 24
- Stable dose of up to 10 mg daily prednisone for at least 6 weeks prior to Week 0 and willingness to maintain it until after Week 24
- Torso circumference between 25 and 50 inches at belly button and sternum
- Willingness to turn off immunomodulation devices at least 4 weeks prior to Week 0 and not resume until after Week 24
- Willingness not to start new immune modulating treatments during the study and to stabilize existing ones by Week 0
- Ability and willingness to follow medication rules in the study's approved Medication Guide
You will not qualify if you...
- Active bacterial or viral infection
- Pregnant or trying to become pregnant
- Receiving active chemotherapy or immunotherapy for cancer within 30 days prior to enrollment
- Received more than three bDMARDs and tsDMARDs
- Received Rituximab monoclonal antibody
- Implanted device or solid object near the spleen interfering with ultrasound
- History of asplenia, splenomegaly, or ascites
- Recent abdominal surgery
- Currently participating in another investigational drug or device study
- Open wounds or sores preventing study procedures
- Unable to perform minimal daily self-care like feeding or dressing
- Refusal or inability to attend scheduled visits or remote observation sessions
- Cannot speak English
- Any other clinical reasons making participant unsuitable as judged by investigators
Research Team
D
Daniel Zachs
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