Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study]
ULTRA
2 other identifiers
interventional
14
1 country
2
Brief Summary
The research objective is to assess efficacy of spleen ultrasound stimulation in the treatment of rheumatoid arthritis (RA) in a pilot study. Specific Aims:
- Measure RA disease activity and clinical metrics during and after an 8-week course of spleen-directed daily ultrasound treatments.
- Measure molecular correlates, including Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), cortisol and cytokine levels, of rheumatoid arthritis disease activity during spleen-directed daily ultrasound treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable rheumatoid-arthritis
Started Jun 2022
Shorter than P25 for not_applicable rheumatoid-arthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedStudy Start
First participant enrolled
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2023
CompletedOctober 12, 2023
October 1, 2023
1.1 years
June 7, 2022
October 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Within-arm change in the Disease Activity Score (DAS-28-CRP) from baseline to the completion of an up-to 8-week treatment period.
A decrease in Disease Activity Score indicates an improved outcome.
8 weeks
Other Outcomes (11)
Within-arm change of serum c-reactive protein (CRP) concentration.
8 weeks
Within-arm change of serum erythrocyte sedimentation rate (ESR).
8 weeks
Within-arm change of serum cortisol levels.
8 weeks
- +8 more other outcomes
Study Arms (1)
Ultrasound Group
EXPERIMENTALInterventions
Daily ultrasound application to the spleen of approximately 18 minutes per day, 5 days per week for up to 8 weeks, in addition to standard clinical care.
Eligibility Criteria
You may qualify if:
- Males and females ages 18 and above
- Must carry a diagnosis of rheumatoid arthritis, as defined by the American College of Rheumatology in 2010: (https://www.rheumatology.org/Portals/0/Files/2010\_revised\_criteria\_classification\_ra.pdf)
- \- Classification as "definite RA" is based on the confirmed presence of synovial thickening in at least 1 joint, absence of an alternative diagnosis that better explains the synovitis, and achievement of a total score of 6 or greater (of a possible 10) from the individual scores in 4 domains: number and site of involved joints (score range 0-5), serologic abnormality (score range 0-3), elevated acute-phase response (score range 0-1), and symptom duration (2 levels; range 0-1)
- Exhibiting symptoms or signs of inadequate inflammatory disease control according to one of two measures:
- Multidimensional HAQ score of greater than 0.3
- DAS-28-CRP greater than 3.2 (http://www.phusewiki.org/wiki/index.php?title=Disease\_Activity\_Score\_-\_CRP\_(DAS-CRP)
- Candidate participant's rheumatoid arthritis medical therapy should be stable for two weeks leading up to the study. Moreover, participants must be willing to maintain their current medication regimen throughout the study enrollment period (in adjunct to the additional investigational ultrasound treatment)
You may not qualify 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 Rituximab monoclonal antibody medication within 30 days prior to enrollment
- Presence of an implanted device
- Asplenia
- Splenomegaly
- Ascites
- Recent abdominal surgery
- Currently participating in an investigational drug or device study
- Open wound/sores near stimulation sites
- Inability to perform minimal daily self-cares associated with feeding/dressing, according to HAQ
- Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SecondWave Systems Inc.lead
- University of Minnesotacollaborator
- DARPA (United States Department of Defense)collaborator
Study Sites (2)
University of Minnesota - Phillips-Wangensteen Building
Minneapolis, Minnesota, 55455, United States
University of Minnesota Health Clinics and Surgery Center
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Peterson, M.D.
University of Minnesota Medical School, Division of Rheumatic and Autoimmune Diseases
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2022
First Posted
June 14, 2022
Study Start
June 29, 2022
Primary Completion
July 19, 2023
Study Completion
September 25, 2023
Last Updated
October 12, 2023
Record last verified: 2023-10