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

Summary

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1

  Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day

• Device
  Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2

  Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day

• Device
  Sham ultrasound stimulation (control)

  Sham ultrasound stimulation for 20 minutes once per day

• Drug
  Conventional Synthetic DMARD

  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

Locations (5)