Is NCT07163221 recruiting in Aurora, CO?

Yes, NCT07163221 is currently recruiting participants at its Aurora, CO location. This rheumatoid arthritis (ra) clinical trial is actively enrolling qualified participants.

How do I join the rheumatoid arthritis (ra) clinical trial in Aurora?

To join this clinical trial in Aurora, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Aurora clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Rheumatoid Arthritis (RA) Clinical Trial in Aurora, CO

About This Rheumatoid Arthritis (RA) Study in Aurora

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.

Sponsor: SecondWave Systems Inc.

Who Can Participate

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.

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, 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

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT07163221) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rheumatoid Arthritis (RA) Treatment Options in Aurora, CO

If you're searching for rheumatoid arthritis (ra) treatment options in Aurora, CO, this clinical trial (NCT07163221) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rheumatoid arthritis (ra) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rheumatoid arthritis (ra) clinical trials near you to find additional studies recruiting in your area.

Rheumatoid Arthritis (RA) Clinical Trial in Aurora, CO

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IRB Approved

No-Cost Care

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