Rheumatoid Arthritis Trial, Recruiting NCT07163221 Sponsor: SecondWave Systems Inc. Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT07163221
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People with active moderate to severe rheumatoid arthritis that has tested positive for certain antibodies (seropositive RA)
  • People who have at least 6 tender and/or swollen joints out of 28 joints checked during the screening process (a joint that is both tender and swollen counts as 2)
  • People whose rheumatoid arthritis did not respond well enough to standard disease-modifying medications (such as methotrexate), or who tried up to three biological or targeted synthetic disease-modifying medications without adequate results
  • People who are currently on a stable dose of a standard disease-modifying medication as a background treatment — methotrexate must have been at a stable dose for at least 4 weeks before the study starts, and all other standard disease-modifying medications for at least 8 weeks before the study starts — and who are willing to continue that same medication throughout the 28-week study
  • People who previously used certain biological or targeted synthetic disease-modifying medications, provided those medications were stopped at least 4 weeks before the study starts (or at least 8 weeks before for Golimumab or Infliximab specifically)
  • People taking up to 10 mg of prednisone (a steroid) daily, provided the dose has been stable for at least 6 weeks before the study starts and they are willing to keep it stable through to the Week 24 visit
  • People whose body measurement around the belly button and chest (sternum) level is between 25 and 50 inches
  • People who have an immune-modulating device implanted, provided they are willing and able to turn it off at least 4 weeks before the study starts and leave it off until after the Week 24 visit
  • People who are willing not to start any new treatments that affect the immune system during the study, and who have stabilised any existing immune-modulating treatments before the study begins
  • People who are willing and able to follow the medication rules set out in the study's approved Medication Guide

Who may not be able to join:

  • People who currently have an active bacterial or viral infection
  • People who are pregnant or trying to become pregnant
  • People who have received chemotherapy or immunotherapy to treat cancer within the past 30 days
  • People who have previously used more than three biological or targeted synthetic disease-modifying medications in total
  • People who have previously received a medication called Rituximab
  • People who have an implanted device or solid object near the spleen area that could interfere with or absorb an ultrasound beam
  • People who have had their spleen removed (asplenia)
  • People who have a history of an enlarged spleen (splenomegaly)
  • People who have a history of fluid build-up in the abdomen (ascites)
  • People who have had recent abdominal surgery (confirm with trial site for specific timeframe)
  • People who are currently taking part in another clinical trial involving an investigational drug or device
  • People who have open wounds or sores that would make completing the study procedures too difficult
  • People who are unable to perform basic daily tasks such as lifting a cup of water to their mouth or putting on clothing
  • People who are unable or unwilling to regularly attend scheduled clinic visits, at-home visits, or remote video sessions
  • People who cannot speak English
  • People who the study investigators determine are not appropriate candidates for the trial for any other clinical reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Daniel Zachs, SecondWave Systems Inc.

Phone: 612-444-6264

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
SecondWave Systems Inc.
Registry
ClinicalTrials.gov
Start date
3 November 2025
Est. completion
1 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in DAS28-CRP score from baseline to 12 weeks, compared between Arm 1 and Arm 3 (sham control); Change in DAS28-CRP score from baseline to 12 weeks , compared between Arm 2 and Arm 3 (sham control)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov