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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
A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where the sites and subjects are blinded to treatment until completion of the parent study. Subjects who were randomized to the inactive device group in the parent study are re-randomized to receive active vagus nerve stimulation either 1 min QD or 1 min QID. Subject who were randomized to the active device groups remain on their assigned treatment (1 min QD, 1 min QID).
Study treatment in SPM-011 begins at the Day 0 Visit. At the Day 0, Week 1, 2, 3, 4 and 5 Visits, all subjects are given the opportunity to have the output current of their implant adjusted to the maximum level tolerated.
From Week 5 onward, subjects will receive their maximally tolerated output current as 1 min QD or 1 min QID treatment.
Follow up assessment visits occur at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33 and 36. Subjects are assessed for safety and durability of response throughout the follow up period. If the subject's symptoms or RA disease worsens, additional concomitant medications are allowed for treatment of their RA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation QD | Active Comparator |
| |
| Active stimulation QID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System | Device | Active Implantable Vagus Nerve Stimulation device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of Adverse Events | Treatment-emergent incidence rates of Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device Effects, and Unanticipated Serious Adverse Device Effects | Enrollment through Month 36 (End of Study) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP) | Mean change in Disease Activity Score (DAS) 28 - C-reactive protein (CRP) | Day 0 through Month 12 |
| American College of Rheumatology (ACR) 20, 50 and 70 response rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Kivitz, MD | Altoona Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthritis & Rheumatic Disease Specialties | Aventura | Florida | 33180 | United States | ||
| Florida Medical Clinic, PA |
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|
Percentage of subjects meeting American College of Rheumatology (ACR) 20, 50 and 70 response status
| Day 0 through Month 12 |
| European League Against Rheumatism (EULAR) response rates | Percentage of subjects meeting European League Against Rheumatism (EULAR) response status of Good, Moderate and None | Day 0 through Month 12 |
| Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission rate | Percentage of subjects meeting Disease Activity Score (DAS) 28 - C-reactive protein (CRP) remission | Day 0 through Month 12 |
| Zephyrhills |
| Florida |
| 33542 |
| United States |
| Northwell Health | Great Neck | New York | 11021 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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