Rheumatoid ArthritisSUSTAINNCT07293871
Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis
A study testing Active treatment in people with Rheumatoid Arthritis, run by Surf Therapeutics at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Active treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, 75034
Sri Lekha Gaddam, 469-498-0417, info@pccrsolutions.com
Dhiman Basu, MD
- Recruiting
Rheumatology Associates
Dallas, Texas, 75231
Holly Hoefer, 214-550-3029, holly.hoefer@heliosclinical.com
Robert Jenkins, MD, PhD
- Recruiting
Precision Comprehensive Clinical Research Solutions
Irving, Texas, 75061
Akshay Shetty, 469-498-0420, info@pccrsolutions.com
Renuka Basavaraju, MD
About this study
Official title: Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled 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 identifying an appropriate effect size and confirming protocol feasibility and safety.
Read the detailed 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 to Week 4, suggests that a second parameter set may be warranted, the Sponsor may elect to enroll an additional 3-5 participants to receive a second active ultrasound parameter set (Experimental Treatment 2). This decision will be made by the Sponsor prior to enrollment of the first participant assigned to Experimental Treatment 2 and will be documented in a protocol decision memo. If the Sponsor determines that Experimental Treatment 1 demonstrates sufficient early signal, Stage 1 will be completed using a single parameter set.
The primary objective of Stage 1 is to assess feasibility, defined as ≥70% adherence to scheduled treatment sessions, and safety, defined by the absence of device-related serious adverse events (SAEs) or Grade ≥2 adverse events (AEs) requiring medical intervention per CTCAE criteria. Data from Stage 1 will be used to refine trial procedures and confirm readiness for Stage 2.
Stage 2 consists of a double-blind, randomized, sham-controlled study enrolling 30-40 participants, randomized 1:1 to receive daily active or sham SUSTAIN therapy for 8 weeks. Selection of the Stage 2 active treatment ultrasound parameter set will be based on the safety profile and magnitude/direction of the DAS28-CRP change from Baseline to Week 4 of the two experimental treatments. Enrollment of seronegative participants is capped at 10 in Stage 2, such that at least 75% of enrolled participants are seropositive. Randomization is stratified by serostatus to maintain balance across arms. This stage is designed to further characterize safety and adherence in a larger cohort, and to estimate treatment effect size using clinical and biomarker-based secondary endpoints.
All participants will be followed through Week 12 to assess post-treatment safety and durability of clinical and immunologic effects.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Active treatment, Sham (No Treatment)
- Keywords
- rheumatoid arthritis, RA, noninvasive, autoimmune, cholinergic anti-inflammatory pathway, neuroimmune modulation, spleen
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active treatmentDevice
Daily active ultrasound stimulation
Sham (No Treatment)Device
Daily sham ultrasound stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Daily active stimulation for 8 weeks Receives: Device: Active treatment |
| Control | Sham comparator | Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
All adverse events (AEs) regardless of treatment group that occur over the 12 week enrollment period will be coded and summarized by frequency, severity, and relatedness using the latest MedDRA version (v28.1).
Measured: 12 weeks
Adherence to Therapy
Proportion of patients adherent to treatment, defined by completing ≥70% of the 56 scheduled ultrasound treatments
Measured: 8 weeks
Secondary outcomes (6)
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Difference between treatment and control groups in the proportion of subjects who achieve at least 20%, 50%, and 70% improvement from baseline to Week 8 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worst) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worst), subject pain (0=no pain to 10=worst), evaluator's global assessment (0=best to 10=worst), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL).
Measured: Week 8
Change in Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP).
Defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worst), subject global assessment (0=best to 10=worst) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L). DAS28-CRP response based on the minimal clinically important difference (MCID) of -1.2 from baseline to week 8.
Measured: Week 8
Change in Heath Assessment Questionnaire Disability Index (HAQ-DI)
Haq-DI assesses physical function through eight daily activity domains (scale 0=no difficulty to 3=unable to do). Change from baseline to week 8 based on the MCID of -0.22.
Measured: Week 8
Change in Clinical Disease Activity Index (CDAI) score for Rheumatoid Arthritis
The CDAI assesses disease activity by summing tender joint count (TJC), swollen joint count (SJC), patient global assessment (PGA), and physician global assessment (EGA). CDAI will be assessed from Baseline to Week 8.
Measured: Week 8
Change in Simplified Disease Activity Index (SDAI) for Rheumatoid Arthritis (RA)
The SDAI is a measure of disease activity that includes all the 4 components of the CDAI, plus CRP. SDAI will be assessed from baseline to Week 8.
Measured: Week 8
Change in high sensitivity CRP (hsCRP)
The primary endpoint is the change in hsCRP from baseline to weeks 2, 4, 6 and 8.
Measured: Weeks 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage 1 is an open-label pilot of 6-10 participants divided into two groups (experimental treatment 1 or experimental treatment 2). Stage 2 is randomized, double-blind, sham-controlled trial of 30-40 participants with 2 arms, active treatment and sham, that are allocated 1:1.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Surf Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293871
- Sponsor's protocol ID
- SURF-CLN-003
- Acronym
- SUSTAIN
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Neuroimmune Modulation in Adults With Rheumatoid Arthritis: Feasibility and Safety in a Multicenter, Randomized, Double-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07293871
- Acronym / sponsor ID
- SUSTAIN / SURF-CLN-003
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, RA, noninvasive, autoimmune, cholinergic anti-inflammatory pathway, neuroimmune modulation, spleen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Surf TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 to Week 4, suggests that a second parameter set may be warranted, the Sponsor may elect to enroll an additional 3-5 participants to receive a second active ultrasound parameter set (Experimental Treatment 2). This decision will be made by the Sponsor prior to enrollment of the first participant assigned to Experimental Treatment 2 and will be documented in a protocol decision memo. If the Sponsor determines that Experimental Treatment 1 demonstrates sufficient early signal, Stage 1 will be completed using a single parameter set.
The primary objective of Stage 1 is to assess feasibility, defined as ≥70% adherence to scheduled treatment sessions, and safety, defined by the absence of device-related serious adverse events (SAEs) or Grade ≥2 adverse events (AEs) requiring medical intervention per CTCAE criteria. Data from Stage 1 will be used to refine trial procedures and confirm readiness for Stage 2.
Stage 2 consists of a double-blind, randomized, sham-controlled study enrolling 30-40 participants, randomized 1:1 to receive daily active or sham SUSTAIN therapy for 8 weeks. Selection of the Stage 2 active treatment ultrasound parameter set will be based on the safety profile and magnitude/direction of the DAS28-CRP change from Baseline to Week 4 of the two experimental treatments. Enrollment of seronegative participants is capped at 10 in Stage 2, such that at least 75% of enrolled participants are seropositive. Randomization is stratified by serostatus to maintain balance across arms. This stage is designed to further characterize safety and adherence in a larger cohort, and to estimate treatment effect size using clinical and biomarker-based secondary endpoints.
All participants will be followed through Week 12 to assess post-treatment safety and durability of clinical and immunologic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Stage 1 is an open-label pilot of 6-10 participants divided into two groups (experimental treatment 1 or experimental treatment 2). Stage 2 is randomized, double-blind, sham-controlled trial of 30-40 participants with 2 arms, active treatment and sham, that are allocated 1:1.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Active treatmentDaily active stimulation for 8 weeks |
| Control | Sham comparator | Device: Sham (No Treatment)Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (31 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active treatmentDaily active ultrasound stimulation | Device | Treatment |
| Sham (No Treatment)Daily sham ultrasound stimulation | Device | Control |
Primary outcome
Incidence of Adverse Events
Time frame: 12 weeks
All adverse events (AEs) regardless of treatment group that occur over the 12 week enrollment period will be coded and summarized by frequency, severity, and relatedness using the latest MedDRA version (v28.1).
Adherence to Therapy
Time frame: 8 weeks
Proportion of patients adherent to treatment, defined by completing ≥70% of the 56 scheduled ultrasound treatments
6 secondary outcomes
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Time frame: Week 8
Change in Disease Activity Score-28 for Rheumatoid Arthritis with CRP (DAS28-CRP).
Time frame: Week 8
Change in Heath Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Week 8
Change in Clinical Disease Activity Index (CDAI) score for Rheumatoid Arthritis
Time frame: Week 8
Change in Simplified Disease Activity Index (SDAI) for Rheumatoid Arthritis (RA)
Time frame: Week 8
Change in high sensitivity CRP (hsCRP)
Time frame: Weeks 2, 4, 6, and 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active treatment in people with Rheumatoid Arthritis, run by Surf Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Sackeim, MD (9145237345, alex@surftherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.