Rheumatoid Arthritis (RA)At-home ULTRANCT07163221

At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]

A study testing Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1, Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2 and Conventional Synthetic DMARD in people with Rheumatoid Arthritis (RA), run by SecondWave Systems Inc. at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis (RA)
What is being tested?: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1, Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2 and Conventional Synthetic DMARD
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 5 sitesUnited States
Study dates: 3 Nov 2025to Jan 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

Males and females ages 18 and above
Active moderate to severe seropositive RA
At least 6 total tender and/or swollen joints counted on a 28 joint assessment during screening and at Week 0 (a joint that is both tender and swollen will be counted as "2")
Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs
Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background treatment) must be maintained at a stable dose for at least 4 weeks prior to Week 0, while all other csDMARDs (if chosen as background treatment) must be maintained at a stable dose for at least 8 weeks prior to Week 0. Participants must be willing to maintain their background medication regimen throughout the 28-week study period.
For participants that have previously undergone treatment with bDMARDs or tsDMARDs therapy, those treatments must be discontinued at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit

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For participants that have previously undergone treatment with Golimumab or Infliximab, those treatments must be discontinued at least 8 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit
Participants may receive up to 10 mg of daily prednisone as part of their background treatment but must have maintained a stable dose for a minimum of 6 weeks prior to start of the treatment period at Week 0, and must be willing to maintain the stable dose until after the Week 24 Closeout Visit
Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches
Participants with an immunomodulation device must be willing and able to turn the device off at least 4 weeks prior to start of the treatment period at Week 0 and may not be resumed until after the Week 24 Closeout Visit
Participants must be willing not to initiate any new treatments with expected immune modulating effects during the study period, and any existing immune modulating treatments must be stabilized by Week 0
Participants must be willing and able to follow the medication rules described in the study's IRB-approved Medication Guide

Who cannot join

Active bacterial or viral infection
Pregnant women or those trying to become pregnant
Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
Having received more than a total of three bDMARDs and tsDMARDs
Having received Rituximab monoclonal antibody medication
Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam

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History of asplenia
History of splenomegaly
History of ascites
Recent abdominal surgery
Currently participating in an investigational drug or device study
Open wound/sores that would make performing study procedures too difficult
Inability to perform minimal daily self-cares associated with feeding or dressing, such as lifting a cup of water to the mouth or putting on clothing.
Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions
Cannot speak English
Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University of Colorado
Aurora, Colorado, 80045
Medvin Clinical Research
Covina, California, 91722
Arizona Arthritis and Rheumatology Associates P.C.
Glendale, Arizona, 85306
University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, 55455
Southland Arthritis & Osteoporosis Medical Center
Temecula, California, 92592

Other trials in United States

About this study

The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, moderate to severe rheumatoid arthritis who are inadequate responders or are intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), or targeted synthetic DMARDs (tsDMARDs). The non-invasive study device delivers ultrasound stimulation to the spleen to reduce inflammation. The study will enroll at least 60 participants at up to 8 sites. There will be three arms consisting of two active stimulation groups (treatment) and one non-active stimulation group (sham-control). After completing the double-blinded primary endpoint assessment period at Week 12, there will be a one-way crossover of control participants to active stimulation and an additional 12 week follow-up with all participants to evaluate long-term outcomes.

Conditions: Rheumatoid Arthritis (RA)
Being tested: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1, Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2, Sham ultrasound stimulation (control), Conventional Synthetic DMARD
Keywords: RA, SecondWave Systems, SecondWave, Rheumatoid Arthritis, Neuromodulation, Ultrasound, Splenic Ultrasound, Spleen, Spleen stimulation, Ultrasound Stimulation, Immunomodulation, spleen stimulating device, drug refractory, noninvasive, non-invasive
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1Device
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2Device
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
Sham ultrasound stimulation (control)Device
Sham ultrasound stimulation for 20 minutes once per day
Conventional Synthetic DMARDDrug
All subjects will take at least one type of conventional synthetic DMARD at the same stable dose for at least 8 weeks prior to the treatment period and continuing through study close out

Study groups in NCT07163221
Study group	Role	What they receive
Control	Sham comparator	Non-active Sham Stimulation Receives: Device: Sham ultrasound stimulation (control); Drug: Conventional Synthetic DMARD
Treatment Setting 1	Experimental	Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day Receives: Device: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1; Drug: Conventional Synthetic DMARD
Treatment Setting 2	Experimental	Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day Receives: Device: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2; Drug: Conventional Synthetic DMARD

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)
A decrease in Disease Activity Score indicates an improved outcome
Measured: 12 weeks
Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)
A decrease in Disease Activity Score indicates an improved outcome
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 2025Jan 2027

First posted9 Sep 2025
Study start3 Nov 2025
Primary completionOct 2026 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatoid Arthritis (RA)Studies 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: A 2-stage, randomized, double-blind, sham-controlled, multicenter study. Participants will be randomized into three groups, where one group is the standard of care control and the other two groups are standard of care plus differing stimulation settings of the SecondWave MINI therapy. Participants assigned to the treatment group will receive active stimulation for 20 min once per day, and those assigned to the control group will receive sham-stimulation for 20 min once per day.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07163221
Sponsor's protocol ID: Pro00087265
Acronym: At-home ULTRA
Status last verified: Sep 2026
First submitted: 1 Sep 2025
Last updated: 14 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis (RA) trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
ClinicalTrials.gov ID: NCT07163221
Acronym / sponsor ID: At-home ULTRA / Pro00087265
Conditions: Rheumatoid Arthritis (RA)
Keywords: RA, SecondWave Systems, SecondWave, Rheumatoid Arthritis, Neuromodulation, Ultrasound, Splenic Ultrasound, Spleen
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: SecondWave Systems Inc.Industry (pharma, biotech, devices)
Study start: 3 Nov 2025 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 9 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: A 2-stage, randomized, double-blind, sham-controlled, multicenter study. Participants will be randomized into three groups, where one group is the standard of care control and the other two groups are standard of care plus differing stimulation settings of the SecondWave MINI therapy. Participants assigned to the treatment group will receive active stimulation for 20 min once per day, and those assigned to the control group will receive sham-stimulation for 20 min once per day.

Arm	Type	Receives
Control	Sham comparator	Device: Sham ultrasound stimulation (control), Drug: Conventional Synthetic DMARDNon-active Sham Stimulation
Treatment Setting 1	Experimental	Device: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1, Drug: Conventional Synthetic DMARDSubjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
Treatment Setting 2	Experimental	Device: Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2, Drug: Conventional Synthetic DMARDSubjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Males and females ages 18 and above
Active moderate to severe seropositive RA
At least 6 total tender and/or swollen joints counted on a 28 joint assessment during screening and at Week 0 (a joint that is both tender and swollen will be counted as "2")
Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs
Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background treatment) must be maintained at a stable dose for at least 4 weeks prior to Week 0, while all other csDMARDs (if chosen as background treatment) must be maintained at a stable dose for at least 8 weeks prior to Week 0. Participants must be willing to maintain their background medication regimen throughout the 28-week study period.

Key exclusion criteria (16 listed)

Active bacterial or viral infection
Pregnant women or those trying to become pregnant
Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
Having received more than a total of three bDMARDs and tsDMARDs
Having received Rituximab monoclonal antibody medication

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
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day	Device	Treatment Setting 1
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day	Device	Treatment Setting 2
Sham ultrasound stimulation (control)Sham ultrasound stimulation for 20 minutes once per day	Device	Control
Conventional Synthetic DMARDAll subjects will take at least one type of conventional synthetic DMARD at the same stable dose for at least 8 weeks prior to the treatment period and continuing through study close out	Drug	Control, Treatment Setting 1, Treatment Setting 2

Primary outcome

Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)
Time frame: 12 weeks
A decrease in Disease Activity Score indicates an improved outcome
Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)
Time frame: 12 weeks
A decrease in Disease Activity Score indicates an improved outcome

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 14 Sep 2026.

Related trials for Rheumatoid Arthritis (RA)

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Active, not recruitingObservational study
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Recruiting
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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. This study is not recruiting at the moment.

Daniel Zachs study director

SecondWave Systems Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control) (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?

On the ClinicalTrials.gov record for NCT07163221.

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 14 Sep 2026.