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

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 assessmentduring screening and at Week 0 (a joint that is both tender and swollen will becounted as "2")

4. Demonstrated an inadequate response to, or loss of response to standard csDMARDtreatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs

5. Receiving stable background treatment with a csDMARD prior to start of the treatmentperiod at Week 0. Methotrexate (if chosen as background treatment) must bemaintained at a stable dose for at least 4 weeks prior to Week 0, while all othercsDMARDs (if chosen as background treatment) must be maintained at a stable dose forat least 8 weeks prior to Week 0. Participants must be willing to maintain theirbackground medication regimen throughout the 28-week study period.

6. For participants that have previously undergone treatment with bDMARDs or tsDMARDstherapy, those treatments must be discontinued at least 4 weeks prior to start ofthe treatment period at Week 0 and may not be resumed until after the Week 24Closeout Visit

7. For participants that have previously undergone treatment with Golimumab orInfliximab, those treatments must be discontinued at least 8 weeks prior to start ofthe treatment period at Week 0 and may not be resumed until after the Week 24Closeout Visit

8. Participants may receive up to 10 mg of daily prednisone as part of their backgroundtreatment but must have maintained a stable dose for a minimum of 6 weeks prior tostart of the treatment period at Week 0, and must be willing to maintain the stabledose until after the Week 24 Closeout Visit

9. Torso circumference at the belly button and sternum level must both be in the rangeof 25 to 50 inches

10. Participants with an immunomodulation device must be willing and able to turn thedevice off at least 4 weeks prior to start of the treatment period at Week 0 and maynot be resumed until after the Week 24 Closeout Visit

11. Participants must be willing not to initiate any new treatments with expected immunemodulating effects during the study period, and any existing immune modulatingtreatments must be stabilized by Week 0

12. Participants must be willing and able to follow the medication rules described inthe 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 daysprior 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 spleenthat 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-homevisits, 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 thepatient would not be an appropriate candidate for the study