At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
NCT ID: NCT07163221
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-11-03
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Non-active Sham Stimulation
Sham ultrasound stimulation (control)
Sham ultrasound stimulation for 20 minutes once per day
Conventional Synthetic DMARD
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
Treatment Setting 1
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 1
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day
Conventional Synthetic DMARD
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
Treatment Setting 2
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
Non-invasive ultrasound stimulation of the spleen - Treatment Setting 2
Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day
Conventional Synthetic DMARD
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
Interventions
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Non-invasive ultrasound stimulation of the spleen - Treatment Setting 1
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 2
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)
Sham ultrasound stimulation for 20 minutes once per day
Conventional Synthetic DMARD
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
Eligibility Criteria
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Inclusion Criteria
2. Active moderate to severe seropositive RA
3. 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")
4. Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and tsDMARDs
5. 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.
6. 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
7. 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
8. 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
9. Torso circumference at the belly button and sternum level must both be in the range of 25 to 50 inches
10. 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
11. 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
Exclusion Criteria
2. Pregnant women or those trying to become pregnant
3. Receiving active chemotherapy or immunotherapy to treat malignancy within 30 days prior to enrollment
4. Having received more than a total of three bDMARDs and tsDMARDs
5. Having received Rituximab monoclonal antibody medication
6. Presence of an implanted device or other solid object in the vicinity of the spleen that can interfere with or absorb the ultrasound beam
7. History of asplenia
8. History of splenomegaly
9. History of ascites
10. Recent abdominal surgery
11. Currently participating in an investigational drug or device study
12. Open wound/sores that would make performing study procedures too difficult
13. 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.
14. Refusal or inability to regularly attend the scheduled on-site visits and at-home visits, or perform the remote video observation sessions
15. Cannot speak English
16. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
18 Years
ALL
No
Sponsors
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SecondWave Systems Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Zachs
Role: STUDY_DIRECTOR
SecondWave Systems Inc.
Locations
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Arizona Arthritis and Rheumatology Associates P.C.
Glendale, Arizona, United States
Medvin Clinical Research
Covina, California, United States
Southland Arthritis & Osteoporosis Medical Center
Temecula, California, United States
University of Colorado
Aurora, Colorado, United States
University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Nathaly Navarro, BS
Role: primary
Rosalia Tanory, MBBS
Role: primary
Adam Ramos
Role: backup
Ana Roup
Role: primary
Chong Pedrick, RN
Role: primary
Panida Khuansanguan, MS
Role: backup
Erik Peterson, M.D.
Role: primary
Other Identifiers
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Pro00087265
Identifier Type: -
Identifier Source: org_study_id