BridgeMD
New treatment option for Rheumatoid Arthritis
Official title Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT07293871
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- hsCRP \> 0.3 mg/dL at the last qualifying visit, baseline or retest
- If on background DMARD therapy, must be on stable dose (see
You likely can't join if
- Able and willing to comply with all study-related procedures, including daily treatment sessions in the study vehicle, research site visits, and...
- Unable to provide informed consent
- Current or planned participation in another treatment clinical trial
- Inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial...
- Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was how well it works
- Conventional synthetic DMARDs:
See the full eligibility 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
- 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 treatment 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...
- Prior use of \>2 biologic or targeted synthetic DMARDs for RA where the primary reason for discontinuation was how well it works
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Colleyville, Texas, United States
- Dallas, Texas, United States
- Irving, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colleyville, Texas, United States; Dallas, Texas, United States; Irving, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.