Vagus Nerve Stimulation for Moderate-to-Severe Rheumatoid Arthritis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: An operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter study. Subjects will be assigned randomly in a 1:1 ratio into either a treatment or control group. Subjects assigned to the treatment group will receive active (therapeutic) stimulation for 1 min once per day, and those assigned to the control group will receive sham (nontherapeutic) stimulation for 1 min once per day.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: All subjects, investigators, joint evaluators and study staff will be blinded. Blinding of subjects and joint evaluators will be assessed at Weeks 4 and 12.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 22 years and 75 years
- Gender
- Both males and females
Description
The RESET-RA study is an operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter pivotal study enrolling 250 subjects at 40 study centers across the U.S. The study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult pat...
The RESET-RA study is an operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter pivotal study enrolling 250 subjects at 40 study centers across the U.S. The study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate-to-severe rheumatoid arthritis (RA) who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). The implant delivers a small amount of electricity (stimulation) to the nerve. All eligible subjects will undergo the surgery under general anesthesia. Half of the subjects will receive therapeutic stimulation (the active treatment group) and the other half will receive non-therapeutic sham stimulation (the sham control). Stimulation will be delivered for 1 min once per day for 12 weeks. Subjects will return for six follow-up visits. All subjects completing Week 12 will be offered participation in a long-term, open-label extension study. All subjects not achieving ACR20 improvement at Week 12 will be eligible for rescue therapy.
Tracking Information
- NCT #
- NCT04539964
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jeffrey R Curtis, MD MPH University of Alabama, Birmingham, AL Principal Investigator: Mark Richardson, MD PhD Massachusetts General Hospital
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