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Neurostimulation Device

Active stimulation QD for Rheumatoid Arthritis

N/A
Waitlist Available
Led By Alan Kivitz, MD
Research Sponsored by SetPoint Medical Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment through month 36 (end of study)
Awards & highlights
No Placebo-Only Group

Summary

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

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through month 36 (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment through month 36 (end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence rates of Adverse Events
Secondary study objectives
American College of Rheumatology (ACR) 20, 50 and 70 response rates
Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP)
Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Active stimulation QDActive Control1 Intervention
Group II: Active stimulation QIDActive Control1 Intervention

Find a Location

Who is running the clinical trial?

SetPoint Medical CorporationLead Sponsor
6 Previous Clinical Trials
330 Total Patients Enrolled
4 Trials studying Rheumatoid Arthritis
300 Patients Enrolled for Rheumatoid Arthritis
Alan Kivitz, MDPrincipal InvestigatorAltoona Center for Clinical Research
7 Previous Clinical Trials
1,882 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
162 Patients Enrolled for Rheumatoid Arthritis
~2 spots leftby Nov 2025
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