Ultrasound Therapy for Rheumatoid Arthritis

(SUSTAIN Trial)

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Surf Therapeutics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This two-stage, multicenter clinical trial is designed to evaluate the feasibility, safety, and preliminary efficacy of at-home ultrasound stimulation to activate immune-neuromodulation in patients with rheumatoid arthritis (RA) and at least moderate disease activity. The study will enroll up to 40 participants at up to 6 sites across 2 stages. The findings from this trial will directly inform the design and power calculations for a future pivotal trial by identifying an appropriate effect size and confirming protocol feasibility and safety for a daily home-use therapy.

Are You a Good Fit for This Trial?

This trial is for adults with Rheumatoid Arthritis (RA) who have at least moderate disease activity. It's designed to see if using ultrasound stimulation at home can help manage RA by changing how the immune system and nerves interact.

Inclusion Criteria

High sensitivity CRP (hsCRP) ≥ 10 mg/L at the screening and baseline visits

I am on a stable dose of my rheumatoid arthritis medication.

Able and willing to comply with all study-related procedures, including at-home device use, daily treatment, scheduled visits, and assessments

Exclusion Criteria

I started or changed the dose of my DMARD medication within the last 12 weeks.

I cannot keep a stable dose of my rheumatoid arthritis medication during the study.

Current or planned participation in another interventional clinical trial

What Are the Treatments Tested in This Trial?

Interventions

• Active treatment
• Sham (No Treatment)

Trial Overview

The study tests an active treatment involving ultrasound stimulation against a sham (no real treatment). Participants will use the therapy daily at home, and researchers aim to learn if it's feasible, safe, and effective before planning a larger trial.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Daily active stimulation for 8 weeks applied at the participant's home by a trained technician.

Group II: Control Placebo Group 1 Intervention

Daily sham stimulation, for 8 weeks, which will look and feel the same as active stimulation, but with no ultrasound energy entering the body, applied by a trained technician at the participant's home.

Who Is Running the Clinical Trial?

Surf Therapeutics

Lead Sponsor

Trials

1

Recruited

20+