NCT04862117Active, not recruiting
Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 22 Feb 2021
- Start date
- 28 Jul 2018
- Primary completion date
- 8 Dec 2026
- Lead sponsor
- SetPoint Medical Corporation
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04862117
What you commit to
- Study type: Interventional
- Participants enrolled: 14
- From 28 Jul 2018 to the primary completion date, 8 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition per the investigator's clinical judgement that precludes participation in the study
Other
- Inability to provide consent
- An adverse event during Study SPM-008 which precludes participation in this study
Who the study is looking for
- Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
- Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arthritis & Rheumatic Disease Specialties Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Great Neck | United States | Unknown status |
| Florida Medical Clinic, PA Coordinator of this site? Confirm its status | Zephyrhills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.