The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.
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
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
Parallel
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1
DeviceSubjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2
DeviceSubjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
Sham ultrasound stimulation (control)
DeviceSham ultrasound stimulation for 20 minutes once per day
Conventional Synthetic DMARD
DrugAll subjects will take at least one type of conventional synthetic DMARD at the same stable dose for at least 8 weeks prior to the treatment period and continuing through study close out
Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)
A decrease in Disease Activity Score indicates an improved outcome
Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)
A decrease in Disease Activity Score indicates an improved outcome
Comparison of responder rate between Arm1 or Arm 2 versus Arm 3 for the ACR20
ACR20, the American College of Rheumatology (ACR) 20 response is defined as 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant
Comparison of responder rate between Arm1 or Arm 2 versus Arm 3 for the ACR50
ACR50, the American College of Rheumatology (ACR) 50 response is defined as 50% improvement in tender and swollen joint counts and 50% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant
Comparison of responder rate between Arm1 or Arm 2 versus Arm 3 for the ACR70
ACR70, the American College of Rheumatology (ACR) 70 response is defined as 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant
Good EULAR response
European Alliance of Associations for Rheumatology (EULAR) "good" response corresponding to clinical improvement in patients with rheumatoid arthritis (RA) and is defined by a DAS28-CRP of ≤3.2 and a DAS28-CRP decrease of more than 1.2 from the baseline score
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