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Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study] (ULTRA)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Splenic Ultrasound

About this trial

This is an interventional device feasibility trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Multidimensional HAQ score of greater than 0.3
2. 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)

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 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

Sites / Locations

University of Minnesota - Phillips-Wangensteen Building
University of Minnesota Health Clinics and Surgery Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasound Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05417854

First Posted

June 7, 2022

Last Updated

October 10, 2023

Sponsor

SecondWave Systems Inc.

Collaborators

University of Minnesota, DARPA (United States Department of Defense)

1. Study Identification

Unique Protocol Identification Number

NCT05417854

Brief Title

Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study]

Acronym

ULTRA

Official Title

Ultrasound Treatment for Rheumatoid Arthritis Study [ULTRA Study]

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

June 29, 2022 (Actual)

Primary Completion Date

July 19, 2023 (Actual)

Study Completion Date

September 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SecondWave Systems Inc.

Collaborators

University of Minnesota, DARPA (United States Department of Defense)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Ultrasound is widely used in human medicine because it is safe, non-invasive, and painless. The same kind of ultrasound that is used for imaging (for example, to visualize babies in utero) may be able to treat inflammatory diseases including Rheumatoid Arthritis. Multiple studies in animals with hyper-inflammation conditions (e.g., inflammatory arthritis and sepsis/lipopolysaccharide [LPS] injections) and recent human studies (e.g., for the treatment of joint inflammation in Rheumatoid Arthritis) have shown that ultrasound applied to the spleen can suppress blood/genetic markers of inflammation. This study will employ investigational ultrasound devices produced by SecondWave Systems called the MINI ultrasound system. This is a pilot single-arm treatment trial in which up to 15 study participants will receive noninvasive splenic-ultrasound therapy over eight weeks (five daily stimulation sessions per week). Clinical outcomes will be compared from baseline to end of the 8-week treatment period. Investigational splenic-ultrasound therapy will be delivered with the SecondWave MINI ultrasound system. The objective of the study is to assess the safety and potential efficacy for the MINI system for treatment of Rheumatoid Arthritis. For ultrasound stimulation, a small wearable ultrasound device is positioned on the upper left abdomen area over the ribs. Study personnel will use an ultrasound imaging device to locate the spleen and to position the wearable MINI device in a proper location around the ribs area. Daily stimulation consists of an approximately 18-minute period for application of ultrasound to the spleen. Collection of clinical outcome data, patient-reported assessments, and blood draws collected at the 5 study visits to assess biomarkers of inflammation will be performed in each participant throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasound Group

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Splenic Ultrasound

Other Intervention Name(s)

SecondWave Systems investigational MINI device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Within-arm change in the Disease Activity Score (DAS-28-CRP) from baseline to the completion of an up-to 8-week treatment period.

Description

A decrease in Disease Activity Score indicates an improved outcome.

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Within-arm change of serum c-reactive protein (CRP) concentration.

Time Frame

8 weeks

Title

Within-arm change of serum erythrocyte sedimentation rate (ESR).

Time Frame

8 weeks

Title

Within-arm change of serum cortisol levels.

Time Frame

8 weeks

Title

Within-arm change of serum Tumor Necrosis Factor (TNFa) concentration.

Time Frame

8 weeks

Title

Within-arm change of serum Interleukin-1 beta (IL-1beta) concentration.

Time Frame

8 weeks

Title

Within-arm change of serum Interleukin-6 (IL-6) concentration.

Time Frame

8 weeks

Title

Within-arm change of serum Interleukin-6 (IL-8) concentration.

Time Frame

8 weeks

Title

Within-arm change of serum Interferon gamma (IFN-gamma) concentration.

Time Frame

8 weeks

Title

Within-arm change on the Multidimensional Health Assessment Questionnaire (HAQ).

Description

A decreased score on the HAQ indicates an improved outcome.

Time Frame

8 weeks

Title

Within-arm change on the EQ-5D health questionnaire.

Description

A decreased score on questions from the EQ-5D indicates an improved outcome.

Time Frame

8 weeks

Title

Exit interview questions.

Description

These questions ask the participant about whether they feel that they have benefited from the investigational treatment, whether they would recommend the investigational treatment to others, and the comfort level of the investigational treatment.

Time Frame

End of study participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erik Peterson, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota - Phillips-Wangensteen Building

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

University of Minnesota Health Clinics and Surgery Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

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