Ultrasound Therapy for Rheumatoid Arthritis

(At-home ULTRA Trial)

Overseen By Daniel Zachs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SecondWave Systems Inc.

Must be taking: CsDMARDs

Must not be taking: Rituximab

Disqualifiers: Infection, Pregnancy, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new at-home ultrasound therapy for people with rheumatoid arthritis, a condition marked by painful, swollen joints. The researchers aim to determine if ultrasound waves can reduce inflammation by targeting the spleen, particularly in those unresponsive to other common treatments. Participants will be divided into groups: some will receive the active therapy, while others will receive a non-active version for comparison. The trial seeks individuals with moderate to severe rheumatoid arthritis who haven't found relief from usual treatments like methotrexate and similar medications. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for those seeking alternatives.

Will I have to stop taking my current medications?

You can continue taking your current csDMARD medication, like methotrexate, as long as you've been on a stable dose for at least 8 weeks before the study and keep it stable during the study. If you've been on bDMARDs or tsDMARDs, you'll need to stop those at least 4 weeks before the study starts, and for Golimumab or Infliximab, at least 8 weeks before. You can also take up to 10 mg of prednisone daily if you've been on a stable dose for at least 6 weeks before the study.

What prior data suggests that this ultrasound therapy is safe for treating rheumatoid arthritis?

Research shows that ultrasound therapy devices, like the one tested in this trial, are generally safe. In a recent study, a similar ultrasound treatment proved safe and effective for reducing pain in arthritis patients. Participants using the ultrasound device experienced fewer side effects and tolerated the treatment well.

The at-home ultrasound device in this trial aims to reduce inflammation by sending sound waves to the spleen. This method is non-invasive, meaning it doesn't involve surgery or injections. Non-invasive treatments usually carry a lower risk of serious side effects compared to more invasive methods.

While specific details on side effects for this trial's device are not yet available, the technology has been used safely in other situations. This provides some confidence in its safety for participants. However, since this is a clinical trial, medical experts closely monitor all potential risks. Participants will be informed of any known risks before deciding to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this ultrasound therapy for rheumatoid arthritis because it offers a new, noninvasive approach to managing the condition. Unlike traditional treatments like NSAIDs, DMARDs, or biologics, which often involve systemic medication, this therapy targets the spleen directly with localized ultrasound waves. This novel delivery method might reduce inflammation without the side effects associated with oral or injectable medications. Plus, the convenience of at-home treatment could greatly enhance patient adherence and quality of life.

What evidence suggests that this trial's ultrasound therapy treatments could be effective for rheumatoid arthritis?

This trial will compare different ultrasound therapy settings for rheumatoid arthritis. Research has shown that ultrasound therapy might help reduce inflammation, a major issue in rheumatoid arthritis. The therapy uses ultrasound waves to target the spleen, encouraging it to produce substances that fight inflammation. Participants in this trial may receive daily noninvasive ultrasound stimulation using either Treatment Setting 1 or Treatment Setting 2. Early results suggest this treatment could benefit those who haven't found relief with standard medications. Although more studies are needed, this method appears promising for individuals with moderate to severe rheumatoid arthritis. ^{1 2 3 4 6}

Who Is on the Research Team?

Hubert Lim

Principal Investigator

SecondWave Systems Inc.

Are You a Good Fit for This Trial?

Adults with active, moderate to severe rheumatoid arthritis who haven't had success with or can't tolerate standard treatments like csDMARDs, bDMARDs, or tsDMARDs. At least 60 participants will be recruited across up to 8 sites.

Inclusion Criteria

At least 6 total tender and/or swollen joints counted on a 28 joint assessment during screening (a joint that is both tender and swollen will be counted as '2')

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

Exclusion Criteria

I currently have an active bacterial or viral infection.

Currently participating in an investigational drug or device study

Pregnant women or those trying to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily noninvasive ultrasound stimulation of the spleen for 20 minutes once per day

12 weeks

Crossover

Control participants crossover to active stimulation

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• At-home Ultrasound Localized Therapy

Trial Overview The trial is testing the MINI system's ability to deliver non-invasive ultrasound stimulation to the spleen as a treatment for reducing inflammation in rheumatoid arthritis patients. It includes two different settings of active treatment and one sham (fake) control group.

How Is the Trial Designed?

Group I: Treatment Setting 2 Experimental Treatment 2 Interventions

Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 2 for 20 minutes once per day

Group II: Treatment Setting 1 Experimental Treatment 2 Interventions

Subjects will receive daily noninvasive ultrasound stimulation of the spleen using Ultrasound Treatment Setting 1 for 20 minutes once per day

Group III: Control Placebo Group 2 Interventions

Non-active Sham Stimulation

Who Is Running the Clinical Trial?

SecondWave Systems Inc.

Lead Sponsor

Trials

4

Recruited

130+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07163221

Study Details | NCT07163221 | At-home Ultrasound ... The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, ...

2. trialx.com trialx.com/clinical-trials/listings/313736/at-home-ultrasound-localized-therapy-for-rheumatoid-arthritis-study-at-home-ultra-study/

At-home Ultrasound Localized Therapy for Rheumatoid ... Overview. The At-Home ULTRA Study will evaluate performance of the MINI system as indicated for the treatment of adults with active, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433054/

Practical Use of Ultrasound in Modern Rheumatology—From ... The US is currently used as the imaging method of choice for establishing an early diagnosis, assessing disease activity, monitoring treatment efficacy.

4. trial.medpath.com trial.medpath.com/clinical-trial/f414e5eea4f06a11/nct07163221-at-home-ultrasound-therapy-rheumatoid-arthritis

At-home Ultrasound Localized Therapy for Rheumatoid ... 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 ...

5. link.springer.com link.springer.com/article/10.1007/s40744-024-00712-y

Clinical and Ultrasonographic Remission in Bio-naïve and ... Here we present the 24-week data of the UPAdacitinib Rheumatoid Arthritis REmission UltraSonography (UPARAREMUS) study, a multicenter ...

6. fusfoundation.org fusfoundation.org/diseases-and-conditions/arthritis/

Arthritis A recent clinical trial was completed in Japan and revealed that MRgFUS ablation was both safe and effective at treating chronic pain caused by ...