243
Participants
Start Date
January 11, 2021
Primary Completion Date
May 16, 2024
Study Completion Date
October 31, 2027
Implant Procedure
The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
Conventional Synthetic DMARD
All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent
Active stimulation
Active stimulation for 1 min once per day
Non-active stimulation
Non-active stimulation for 1 min once per day
Long Island Regional Arthritis & Osteoporosis Care, Babylon
Lehigh Valley Health Network, Allentown
University of Pennsylvania Medical Center, Philadelphia
Delaware Arthritis, Lewes
Annapolis Rheumatology, Fairfax
West Virginia University, Morgantown
DJL Clinical Research, Charlotte
Parris and Associates Rheumatology, Lawrenceville
Augusta University, Augusta
Arthritis & Rheumatic Disease Specialties, Aventura
IRIS Research and Development, Plantation
RecioMed Clinical Research Network, Inc., Boynton Beach
Bay Area Rheumatology, Clearwater
HARAC Research Corporation, Avon Park
June DO, PC, Lansing
Saint Paul Rheumatology, P.A., Eagan
Willow Rheumatology and Wellness PLLC, Willowbrook
Northwestern University, Chicago
West County Rheumatology, St Louis
Kansas City Physician Partners, Kansas City
Physician Research Collaboration, LLC, Lincoln
Health Research of Oklahoma, PLLC, Oklahoma City
Arthritis & Rheumatology Research Institute, PLLC, Allen
Southwest Rheumatology Research LLC, Mesquite
Precision Comprehensive Clinical Research Solutions, Colleyville
Biopharma Informatic, Houston
Clinical Trials of Texas, Inc, San Antonio
Austin Regional Clinic, Austin
Tekton Research, Austin
Central Texas Rheumatology Associates, Austin
The Arthritis & Rheumatology Clinic of Northern Colorado, Fort Collins
Arizona Arthritis Rheumatology & Research, PLLC, Phoenix
Arizona Arthritis ans Rheumatology Research, PPLC, Mesa
Arizona Arthritis & Rheumatology Research, PLLC, Tucson
Albuquerque Center for Rheumatology, Albuquerque
Medvin Clinical Research, Whittier
Medvin Clinical Research, Covina
Inland Rheumatology Clinical Trials, Upland
Sound Clinical Research, LLC, Bothell
Stamford Therapeutics Consortium, Stamford
Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology, Boston
SetPoint Medical Corporation
INDUSTRY