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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
Sham ultrasound stimulation for 20 minutes once per day
All 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
Arizona Arthritis and Rheumatology Associates P.C.
Glendale, Arizona, United States
RECRUITINGMedvin Clinical Research
Covina, California, United States
RECRUITINGSouthland Arthritis & Osteoporosis Medical Center
Temecula, California, United States
RECRUITINGUniversity of Colorado
Aurora, Colorado, United States
RECRUITINGUniversity of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, United States
RECRUITINGChange 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
Time frame: 12 weeks
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
Time frame: 12 weeks
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