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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
Study Summary
This study is evaluating whether a device that stimulates the vagus nerve can be used to treat rheumatoid arthritis.
Eligible Conditions
- Rheumatoid Arthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment through month 36 (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment through month 36 (end of study)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence rates of Adverse Events
Secondary outcome measures
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 moreTrial Design
2Treatment groups
Active Control
Group I: Active stimulation QDActive Control1 Intervention
Group II: Active stimulation QIDActive Control1 Intervention
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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
Frequently Asked Questions
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