Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Where in Egyesült Államok
- Aventura · Arthritis & Rheumatic Disease SpecialtiesIsmeretlen állapot
- Duncansville · Altoona Center For Clinical ResearchIsmeretlen állapot
- Great Neck · Northwell HealthIsmeretlen állapot
- Zephyrhills · Florida Medical Clinic, PAIsmeretlen állapot
The registry text, word for word
Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis
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
Inclusion: 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.
Exclusion: Any condition per the investigator's clinical judgement that precludes participation in the study; Inability to provide consent; An adverse event during Study SPM-008 which precludes participation in this study.