The trial is taking place at:
I

IRIS Research and Development | Plantation, FL

Veeva-enabled site

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (RESET-RA)

S

SetPoint Medical

Status and phase

Active, not recruiting
Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Procedure: Implant Procedure
Drug: Conventional Synthetic DMARD
Device: Active stimulation
Device: Non-active stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04539964
SPM-020

Details and patient eligibility

About

The RESET-RA 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 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 placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll 250 subjects at 40 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.

Full 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 patients with active, moderate to severe rheumatoid arthritis (RA) who have had an inadequate response, loss of 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 active stimulation (the treatment group) and the other half will receive non-active stimulation (the control group). Stimulation will be delivered for 1 min once per day for 12 weeks. After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety. Blinding will be maintained until the last enrolled and randomized subject in Stage 2 completes Week 12 assessments, and the study database is locked.

Enrollment

250 estimated patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 22-75 years of age at screening
  • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
  • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
  • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

Exclusion criteria

  • Untreated or poorly controlled psychiatric illness or history of substance abuse
  • Significant immunodeficiency due to underlying illness
  • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
  • Clinically significant cardiovascular disease
  • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
  • Uncontrolled fibromyalgia
  • History of left or right carotid surgery
  • History of unilateral or bilateral vagotomy, partial or complete splenectomy
  • Recurrent vasovagal syncope episodes
  • Current, regular use of tobacco products
  • Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

250 participants in 2 patient groups

Treatment
Experimental group
Description:
Active stimulation for 1 min once per day
Treatment:
Device: Active stimulation
Drug: Conventional Synthetic DMARD
Procedure: Implant Procedure
Control
Sham Comparator group
Description:
Non-active stimulation for 1 min once per day
Treatment:
Device: Non-active stimulation
Drug: Conventional Synthetic DMARD
Procedure: Implant Procedure

Trial contacts and locations

43

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Central trial contact

Manager of Clinical Operations at SetPoint Medical; Call Center for RESET-RA

Data sourced from clinicaltrials.gov

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