Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
brief summary
This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of at-home ultrasound stimulation to activate immune-neuromodulation in patients with rheumatoid arthritis (RA) and at least moderate disease activity. The study will enroll up to 40 participants at up to 6 sites across 2 stages. The findings from this trial will directly inform the design and power calculations for a future pivotal trial by identifying an appropriate effect size and confirming protocol feasibility and safety for a daily home-use therapy.
detailed description
Stage 1 is an open-label pilot study of 5-8 participants receiving active daily ultrasound stimulation for 8 weeks. The primary objective is to assess feasibility and safety, defined by the absence of device-related serious adverse events (SAEs) or Grade ≥2 adverse events (AEs) requiring medical intervention per CTCAE criteria. Data from Stage 1 will be used to refine trial procedures and confirm readiness for Stage 2.
Stage 2 consists of a randomized double-blind, sham-controlled study enrolling up to 30 participants, allocated 2:1 to receive active or sham daily ultrasound stimulation for 8 weeks. This stage is designed to estimate the treatment effect size, using clinical and biomarker-based endpoints, and to collect safety and adherence data on a larger cohort.
All participants will be followed through Week 12 to assess post-treatment safety and durability of clinical and immunologic effects.
official title
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial