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Clinical Trials in the USA / NCT07293871
Recruiting Not applicable

Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis

NCT07293871 · tracked via the Priya Life Science USA tracker
Sponsor
Surf Therapeutics
Phase
Not applicable
Started
2026-03-20
Last updated
2026-07-07

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Active treatmentSham (No Treatment)

Active treatment: Daily active ultrasound stimulation

Sham (No Treatment): Daily sham ultrasound stimulation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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 assessments Exclusion Criteria: * Unable to provide informed consent * Current or planned participation in another interventional clinical trial * Inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis. Current diagnosis of secondary Sjogren's Syndrome is permitted. * Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was efficacy * Conventional synthetic DMARDs: * Initiation within 12 weeks prior to enrollment * Dose adjustment or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Biologic DMARDs: * Initiation or dose adjustment within 12 weeks prior to enrollment * Discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * JAK inhibitors: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * If on a stable dose, inability to maintain the stable dose during the study period * Corticosteroids: * Initiation, dose adjustment, or discontinuation within 4 weeks prior to enrollment * Current dose \>10 mg/day prednisone (or equivalent) * If on a stable dose, inability to maintain the stable dose during the study * NSAIDs: * Initiation, dose adjustment, or discontinuation of high-dose NSAIDs (≥1200 mg/day ibuprofen) within 14 days of informed consent. Over-the-counter use of NSAIDs is permissible. * Pregnant or planning to become pregnant during the study period * Known hypersensitivity to ultrasound gel or membrane components * History of splenic disorders, including splenectomy, congenital asplenia, or splenomegaly on baseline visit ultrasound * Rash, wound, or skin infection overlying the spleen * History of vagal nerve injury, vagotomy, or known autonomic neuropathy * Recent abdominal surgery or trauma within 30 days of screening * Skin to spleen hilum depth \>7 cm as measured by ultrasound at the baseline visit * Abdominal anatomy or condition precluding adequate ultrasound targeting of the spleen * Uncontrolled fibromyalgia or other diffuse pain syndromes that may confound symptom reporting * Any condition that, in the investigator's judgment, would preclude safe participation or compliance with study procedures

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Precision Comprehensive Clinical Research Solutions Colleyville Texas Recruiting
Rheumatology Associates Dallas Texas Recruiting
Precision Comprehensive Clinical Research Solutions Irving Texas Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07293871 on ClinicalTrials.gov ↗ ← All trials in the USA