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

Conditions

• Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1 — DEVICE
  Subjects 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 — DEVICE
  Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
• Sham ultrasound stimulation (control) — DEVICE
  Sham ultrasound stimulation for 20 minutes once per day
• Conventional Synthetic DMARD — DRUG
  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

Study Details

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.

Key Dates

Start date

Nov 3, 2025

Status verified

Feb 2026

Primary completion

Aug 31, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Sham Comparator: Control
  Non-active Sham Stimulation
• Experimental: Treatment Setting 1
  Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
• Experimental: Treatment Setting 2
  Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day

Primary Outcome Measure

Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control) [ Time Frame: 12 weeks ]

Central Contacts

• Daniel Zachs
  612-444-6264
  [email protected]

Locations (5)

Find similar trials in Glendale, AZ

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