At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study] (NCT07163221) | Clinical Trial Compass
RecruitingNot Applicable
At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
United States60 participantsStarted 2025-11-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control)
Timeframe: 12 weeks
2
Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)
. 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
. 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
Exclusion criteria
. 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