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Could a tiny neck implant calm rheumatoid arthritis without pills?

NCT ID NCT04539964

Disease control Sponsor: SetPoint Medical Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a small device implanted on the vagus nerve in the neck to treat moderate to severe rheumatoid arthritis. About 243 adults who did not get enough relief from standard drugs will receive either active or inactive stimulation for 12 weeks, then all will receive active stimulation for long-term follow-up. The goal is to see if the device safely reduces joint swelling and pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

243 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102, United States

  • Annapolis Rheumatology

    Fairfax, Virginia, 22033, United States

  • Arizona Arthritis & Rheumatology Research, PLLC

    Tucson, Arizona, 85704, United States

  • Arizona Arthritis Rheumatology & Research, PLLC

    Phoenix, Arizona, 85037, United States

  • Arizona Arthritis ans Rheumatology Research, PPLC

    Mesa, Arizona, 85210, United States

  • Arthritis & Osteoporosis Consultants Of The Carolinas

    Charleston, North Carolina, 28202, United States

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Arthritis & Rheumatology Research Institute, PLLC

    Allen, Texas, 75013, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Austin Regional Clinic

    Austin, Texas, 78717, United States

  • Bay Area Rheumatology

    Clearwater, Florida, 33765, United States

  • Biopharma Informatic

    Houston, Texas, 77043, United States

  • Central Texas Rheumatology Associates

    Austin, Texas, 78746, United States

  • Clinical Trials of Texas, Inc

    San Antonio, Texas, 78229, United States

  • DJL Clinical Research

    Charlotte, North Carolina, 28210, United States

  • Delaware Arthritis

    Lewes, Delaware, 19958, United States

  • HARAC Research Corporation

    Avon Park, Florida, 33825, United States

  • Health Research of Oklahoma, PLLC

    Oklahoma City, Oklahoma, 73103, United States

  • IRIS Research and Development

    Plantation, Florida, 33324, United States

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786, United States

  • June DO, PC

    Lansing, Michigan, 48910, United States

  • Kansas City Physician Partners

    Kansas City, Missouri, 64151, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Long Island Regional Arthritis & Osteoporosis Care

    Babylon, New York, 11702, United States

  • Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology

    Boston, Massachusetts, 02114, United States

  • Medvin Clinical Research

    Covina, California, 91722, United States

  • Medvin Clinical Research

    Whittier, California, 90602, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Parris and Associates Rheumatology

    Lawrenceville, Georgia, 30044, United States

  • Physician Research Collaboration, LLC

    Lincoln, Nebraska, 68516, United States

  • Precision Comprehensive Clinical Research Solutions

    Colleyville, Texas, 76034, United States

  • RecioMed Clinical Research Network, Inc.

    Boynton Beach, Florida, 33472, United States

  • Saint Paul Rheumatology, P.A.

    Eagan, Minnesota, 55121, United States

  • Sound Clinical Research, LLC

    Bothell, Washington, 98021, United States

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150, United States

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905, United States

  • Tekton Research

    Austin, Texas, 78745, United States

  • The Arthritis & Rheumatology Clinic of Northern Colorado

    Fort Collins, Colorado, 80528, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • West County Rheumatology

    St Louis, Missouri, 63122, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

  • Willow Rheumatology and Wellness PLLC

    Willowbrook, Illinois, 60527, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.