Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
Surf Therapeutics
Summary
This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of splenic ultrasound stimulation to activate immune-neuromodulation (SUSTAIN) in patients with rheumatoid arthritis (RA) and at least moderate disease activity. 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.
Description
Stage 1 is an open-label pilot study of 6-10 participants. To maintain a seropositive-enriched cohort, enrollment of seronegative participants (those with RF ≤14 IU/mL and Anti-CCP \<20 U/mL) is capped at 3 participants in Stage 1. All participants will receive daily active SUSTAIN therapy for 8 weeks. The initial active ultrasound parameter set (Experimental Treatment 1) will be based on the best available evidence at the start of the trial. If interim review of early efficacy data from the first 3-5 participants, specifically, the magnitude and direction of change in DAS28-CRP from Baseline…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At least 18 years old * Diagnosis of rheumatoid arthritis as defined by ACR/EULAR 2010 classification criteria * At least moderate disease activity, defined as ≥4 tender joints (28-joint count) and ≥4 swollen joints (28-joint count) and a DAS28-CRP \>3.2 at the baseline visit * hsCRP \> 0.3 mg/dL at the last qualifying visit, baseline or retest * If on background DMARD therapy, must be on stable dose (see exclusion criteria) * Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and a…
Interventions
- DeviceActive treatment
Daily active ultrasound stimulation
- DeviceSham (No Treatment)
Daily sham ultrasound stimulation
Locations (3)
- Precision Comprehensive Clinical Research SolutionsColleyville, Texas
- Rheumatology AssociatesDallas, Texas
- Precision Comprehensive Clinical Research SolutionsIrving, Texas