Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
Recruiting
N/A
Interventional Study
Rheumatoid Arthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Surf Therapeutics · Industry
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About This Trial
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 identif…
Trial Locations
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Eligibility Criteria
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
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Contacts