At-home ultrasound spleen therapy for rheumatoid arthritis

At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]

This study tests whether an at-home, non-invasive ultrasound device that stimulates the spleen can reduce inflammation and symptoms in adults with active moderate-to-severe rheumatoid arthritis who haven’t responded to or cannot tolerate conventional DMARD medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SecondWave Systems Inc. (Industry-sponsored)
• Drugs / interventions: Golimumab, Infliximab, Rituximab, chemotherapy, immunotherapy, methotrexate, prednisone
• Locations: 5 sites (Glendale, Arizona and 4 other locations)
• Trial ID: NCT07163221 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind study enrolls at least 60 adults with active, seropositive moderate-to-severe RA and compares two active ultrasound stimulation settings to a sham control. The non-invasive device is used at home to deliver ultrasound stimulation to the spleen with the goal of reducing systemic inflammation. Participants remain on a stable background csDMARD regimen and are followed for a double-blind primary endpoint at Week 12, after which sham participants cross over to active treatment and all participants are followed for an additional 12 weeks. The trial is planned at multiple U.S. sites and uses joint counts and clinical outcomes to measure response.

Who should consider this trial

Good fit: Adults (18+) with active, seropositive moderate-to-severe RA who have at least six tender and/or swollen joints and who have had an inadequate response or intolerance to csDMARDs, bDMARDs, or tsDMARDs while on a stable csDMARD background regimen are the intended candidates.

Not a fit: People with mild RA, those who respond well to existing DMARD therapy, those who cannot use or tolerate the at-home device, or those who do not meet the joint-count or medication stability requirements are unlikely to receive benefit from participating.

Why it matters

Potential benefit: If successful, the device could provide a non-drug, at-home option to lower inflammation and improve symptoms for people with RA who do not respond to current medications.

How similar studies have performed: Bioelectronic immunomodulation approaches like vagus nerve stimulation have shown early positive signals in RA, but ultrasound stimulation of the spleen is a relatively novel approach with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Males and females ages 18 and above
2. Active moderate to severe seropositive RA
3. At least 6 total tender and/or swollen joints counted on a 28 joint assessment during screening and at Week 0 (a joint that is both tender and swollen will be counted as "2")
4. Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs
5. Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background treatment) must be maintained at a stable dose for at least 4 weeks prior to Week 0, while all other csDMARDs (if chosen as background treatment) must be maintained at a stable dose for at least 8 weeks prior to Week 0. Participants must be willing to maintain their background medication regimen throughout the 28-week study period.
6. For participants that have previously undergone treatment with bDMARDs or tsDMARDs therapy, those treatments must be discontinued at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit
7. For participants that have previously undergone treatment with Golimumab or Infliximab, those treatments must be discontinued at least 8 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit
8. Participants may receive up to 10 mg of daily prednisone as part of their background treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the treatment period at Week 0, and must be willing to maintain the stable dose until after the Week 24 Closeout Visit
9. Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches
10. Participants with an immunomodulation device must be willing and able to turn the device off at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit
11. Participants must be willing not to initiate any new treatments with expected immune modulating effects during the study period, and any existing immune modulating treatments must be stabilized by Week 0
12. Participants must be willing and able to follow the medication rules described in the study's IRB-approved Medication Guide

Exclusion Criteria:

1. Active bacterial or viral infection
2. Pregnant women or those trying to become pregnant
3. Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
4. Having received more than a total of three bDMARDs and tsDMARDs
5. Having received Rituximab monoclonal antibody medication
6. Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam
7. History of asplenia
8. History of splenomegaly
9. History of ascites
10. Recent abdominal surgery
11. Currently participating in an investigational drug or device study
12. Open wound/sores that would make performing study procedures too difficult
13. Inability to perform minimal daily self-cares associated with feeding or dressing, such as lifting a cup of water to the mouth or putting on clothing.
14. Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions
15. Cannot speak English
16. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

Where this trial is running

Glendale, Arizona and 4 other locations

• Arizona Arthritis and Rheumatology Associates P.C. — Glendale, Arizona, United States (Recruiting)
• Medvin Clinical Research — Covina, California, United States (Recruiting)
• Southland Arthritis & Osteoporosis Medical Center — Temecula, California, United States (Recruiting)
• University of Colorado — Aurora, Colorado, United States (Recruiting)
• University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Study coordinator: Daniel Zachs

Conditions Rheumatoid Arthritis; RA; SecondWave Systems; SecondWave; Neuromodulation; Ultrasound; Splenic Ultrasound; Spleen