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

Inclusion criteria

• Males and females ages 18 and above
• Active moderate to severe seropositive RA
• 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")
• Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs
• 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.
• 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
• 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
• 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
• Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches
• 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
• 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
• Participants must be willing and able to follow the medication rules described in the study's IRB-approved Medication Guide

Exclusion criteria

• Active bacterial or viral infection
• Pregnant women or those trying to become pregnant
• Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
• Having received more than a total of three bDMARDs and tsDMARDs
• Having received Rituximab monoclonal antibody medication
• Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam
• History of asplenia
• History of splenomegaly
• History of ascites
• Recent abdominal surgery
• Currently participating in an investigational drug or device study
• Open wound/sores that would make performing study procedures too difficult
• 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.
• Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions
• Cannot speak English
• Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study