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New treatment option for Rheumatoid Arthritis (RA)
Official title At-home Ultrasound Localized Therapy for Rheumatoid Arthritis Study [At-home ULTRA Study]
ClinicalTrials.gov ID: NCT07163221
What this study is testing
What is Conventional Synthetic DMARD?
Conventional Synthetic DMARD is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis (ra).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Demonstrated an inadequate response to, or loss of response to standard csDMARD treatment (e.g., methotrexate) or up to three total bDMARDs and...
- Receiving stable background treatment with a csDMARD prior to start of the treatment period at Week 0. Methotrexate (if chosen as background...
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Glendale, Arizona, United States
- Covina, California, United States
- Temecula, California, United States
- Aurora, Colorado, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glendale, Arizona, United States; Covina, California, United States; Temecula, California, United States; Aurora, Colorado, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.