Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT07293871
- Run by
- Surf Therapeutics
- People needed
- 40
- Starts
- 2026-03-20
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Precision Comprehensive Clinical Research Solutions — Colleyville, Texas, United States (enrolling)
- Rheumatology Associates — Dallas, Texas, United States (enrolling)
- Precision Comprehensive Clinical Research Solutions — Irving, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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