Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 (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 (e.g. methotrexate) for at least 8 weeks prior to start of the treatment period at 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.
  • - 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.

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 on the spleen side of the torso that can interfere with or absorb the ultrasound beam.
  • - 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/dressing, according to HAQ.
  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07163221
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 SecondWave Systems Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hubert Lim
Principal Investigator Affiliation SecondWave Systems Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis (RA)
Arms & Interventions

Arms

Sham Comparator: Control

Non-active Sham Stimulation

Experimental: Treatment Setting 1

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

Experimental: Treatment Setting 2

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

Interventions

Device: - 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

Device: - 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

Device: - Sham ultrasound stimulation (control)

Sham ultrasound stimulation for 20 minutes once per day

Drug: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases

Minneapolis 5037649, Minnesota 5037779, 55455

Site Contact

Erik Peterson, M.D.

[email protected]

612-273-3000

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