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Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis (RESET-RA)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Implant Procedure
Conventional Synthetic DMARD
Active stimulation
Non-active stimulation
Sponsored by
SetPoint Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Vagus nerve, vagus nerve stimulating device, drug refractory, permanent implantable, implant

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 22-75 years of age at screening
  • Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints
  • Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi)
  • Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12

Exclusion Criteria:

  • Untreated or poorly controlled psychiatric illness or history of substance abuse
  • Significant immunodeficiency due to underlying illness
  • History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia
  • Clinically significant cardiovascular disease
  • Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease
  • Uncontrolled fibromyalgia
  • History of left or right carotid surgery
  • History of unilateral or bilateral vagotomy, partial or complete splenectomy
  • Recurrent vasovagal syncope episodes
  • Current, regular use of tobacco products
  • Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Arthritis ans Rheumatology Research, PPLCRecruiting
  • Arizona Arthritis Rheumatology & Research, PLLCRecruiting
  • Arizona Arthritis & Rheumatology Research, PLLCRecruiting
  • Medvin Clinical ResearchRecruiting
  • Inland Rheumatology Clinical TrialsRecruiting
  • Medvin Clinical ResearchRecruiting
  • The Arthritis & Rheumatology Clinic of Northern ColoradoRecruiting
  • Stamford Therapeutics ConsortiumRecruiting
  • Delaware ArthritisRecruiting
  • Arthritis & Rheumatic Disease SpecialtiesRecruiting
  • HARAC Research CorporationRecruiting
  • RecioMed Clinical Research Network, Inc.
  • Bay Area RheumatologyRecruiting
  • IRIS Research and DevelopmentRecruiting
  • West Broward Rheumatology Associates
  • Florida Medical Clinic, LLC
  • Augusta UniversityRecruiting
  • Parris and Associates RheumatologyRecruiting
  • Northwestern UniversityRecruiting
  • Hinsdale Orthopaedics Illinois Bone and Joint InstituteRecruiting
  • Massachusetts General Hospital Division of Rheumatology, Allergy, and ImmunologyRecruiting
  • UMass Memorial Medical CenterRecruiting
  • June DO, PCRecruiting
  • Saint Paul Rheumatology, P.A.Recruiting
  • Kansas City Physician PartnersRecruiting
  • West County RheumatologyRecruiting
  • Physician Research Collaboration, LLCRecruiting
  • Albuquerque Center for RheumatologyRecruiting
  • Long Island Regional Arthritis & Osteoporosis CareRecruiting
  • DJL Clinical ResearchRecruiting
  • PMG Research
  • Health Research of Oklahoma, PLLCRecruiting
  • Lehigh Valley Health NetworkRecruiting
  • Altoona Center for Clinical ResearchRecruiting
  • University of Pennsylvania Medical CenterRecruiting
  • West Tennessee Research Institute
  • Arthritis & Rheumatology Research Institute, PLLCRecruiting
  • Austin Regional Clinic
  • Tekton ResearchRecruiting
  • Central Texas Rheumatology AssociatesRecruiting
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Biopharma Informatic
  • Southwest Rheumatology Research LLCRecruiting
  • Clinical Trials of Texas, IncRecruiting
  • Annapolis RheumatologyRecruiting
  • Sound Clinical Research, LLCRecruiting
  • Arthritis Northwest Rheumatology, PLLC
  • University Physicians and Surgeons, INC dba Marshall Health
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment

Control

Arm Description

Active stimulation for 1 min once per day

Non-active stimulation for 1 min once per day

Outcomes

Primary Outcome Measures

the American College of Rheumatology (ACR) 20 response
Difference between treatment and control groups in the proportion of subjects who achieve at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worse) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worse), evaluator's global assessment (0=best to 10=worse), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL) with higher values representing worse outcome.

Secondary Outcome Measures

The Disease Activity Score 28-C-reactive protein (DAS28-CRP) good or moderate response as defined by European League Against Rheumatism (EULAR)
The DAS28-CRP good or moderate response as defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worse), subject global assessment (0=best to 10=worse) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L) with higher values representing worse outcome
DAS28-CRP response (MCID -1.2) at Week 12
DAS28-CRP response based on the minimal clinically important difference (MCID) of -1.2 from baseline
Health Assessment Questionnaire Disability Index (HAQ-DI) response (MCID -0.22)
HAQ-DI response based on the MCID of -0.22 from baseline
ACR20 response at Week 12 from Day 0
Difference between treatment and control groups in the proportion of subjects who achieve at least 20% improvement from Day 0 to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worse) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worse), evaluator's global assessment (0=best to 10=worse), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL) with higher values representing worse outcome.

Full Information

First Posted
August 31, 2020
Last Updated
October 11, 2023
Sponsor
SetPoint Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04539964
Brief Title
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
Acronym
RESET-RA
Official Title
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SetPoint Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The RESET-RA study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck (implant procedure). The study will enroll 250 subjects at 40 sites. All eligible subjects will undergo the implant procedure. Half of the subjects will receive active stimulation (treatment) and the other half will receive non-active stimulation (control). After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety.
Detailed Description
The RESET-RA study is an operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter pivotal study enrolling 250 subjects at 40 study centers across the U.S. The study will assess the safety and efficacy of the SetPoint System (study device) for the treatment of adult patients with active, moderate to severe rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). The study device contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). The implant delivers a small amount of electricity (stimulation) to the nerve. All eligible subjects will undergo the surgery under general anesthesia. Half of the subjects will receive active stimulation (the treatment group) and the other half will receive non-active stimulation (the control group). Stimulation will be delivered for 1 min once per day for 12 weeks. After completing primary endpoint assessments at Week 12, there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects (treatment and control) receiving active stimulation to evaluate long-term safety. Blinding will be maintained until the last enrolled and randomized subject in Stage 2 completes Week 12 assessments, and the study database is locked.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Vagus nerve, vagus nerve stimulating device, drug refractory, permanent implantable, implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
An operationally seamless, 2-stage, randomized, double-blind, sham-controlled, multicenter study. Subjects will be assigned randomly in a 1:1 ratio into either a treatment or control group. Subjects assigned to the treatment group will receive active stimulation for 1 min once per day, and those assigned to the control group will receive non-active stimulation for 1 min once per day.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All subjects, investigators, joint evaluators and study staff will be blinded. Blinding of subjects, joint evaluators and investigators will be assessed at Weeks 4 and 12.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active stimulation for 1 min once per day
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Non-active stimulation for 1 min once per day
Intervention Type
Procedure
Intervention Name(s)
Implant Procedure
Other Intervention Name(s)
Surgical placement of vagus nerve stimulator inside the neck
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Conventional Synthetic DMARD
Other Intervention Name(s)
Background therapy with conventional synthetic DMARD
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Active stimulation
Intervention Description
Active stimulation for 1 min once per day
Intervention Type
Device
Intervention Name(s)
Non-active stimulation
Intervention Description
Non-active stimulation for 1 min once per day
Primary Outcome Measure Information:
Title
the American College of Rheumatology (ACR) 20 response
Description
Difference between treatment and control groups in the proportion of subjects who achieve at least 20% improvement from baseline to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worse) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worse), evaluator's global assessment (0=best to 10=worse), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL) with higher values representing worse outcome.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
The Disease Activity Score 28-C-reactive protein (DAS28-CRP) good or moderate response as defined by European League Against Rheumatism (EULAR)
Description
The DAS28-CRP good or moderate response as defined by EULAR based on a composite score of 4 items: tender and swollen joint counts of 28 joints (scale 0=best to 28=worse), subject global assessment (0=best to 10=worse) and high-sensitivity C-reactive protein (hsCRP) concentration (mg/L) with higher values representing worse outcome
Time Frame
Week 12
Title
DAS28-CRP response (MCID -1.2) at Week 12
Description
DAS28-CRP response based on the minimal clinically important difference (MCID) of -1.2 from baseline
Time Frame
Week 12
Title
Health Assessment Questionnaire Disability Index (HAQ-DI) response (MCID -0.22)
Description
HAQ-DI response based on the MCID of -0.22 from baseline
Time Frame
Week 12
Title
ACR20 response at Week 12 from Day 0
Description
Difference between treatment and control groups in the proportion of subjects who achieve at least 20% improvement from Day 0 to Week 12 in tender and swollen joint counts of 28 joints (scale 0=best to 28=worse) and 3 out of the following 5 measures: Health Assessment Questionnaire Disability Index (HAQ-DI) score (scale 0=no difficulty to 3=unable to do), subject global assessment (0=best to 10=worse), subject pain (0=no pain to 10=worse), evaluator's global assessment (0=best to 10=worse), or high sensitivity C-reactive protein (hsCRP) concentration (mg/mL) with higher values representing worse outcome.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 22-75 years of age at screening Active moderate or severe RA, defined as at least 4/28 tender and 4/28 swollen joints Demonstrated an inadequate response, loss of response, or intolerance to 1 or more approved for rheumatoid arthritis biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including Janus kinase inhibitors (JAKi) Receiving treatment with at least 1 conventional synthetic DMARD for at least 12 weeks and on a continuous non-changing dose and route of administration for at least 4 weeks prior to Screening and able to continue the same stable dose through Week 12 Exclusion Criteria: Untreated or poorly controlled psychiatric illness or history of substance abuse Significant immunodeficiency due to underlying illness History of stroke or transient ischemic attack, or diagnosis of cerebrovascular fibromuscular dysplasia Clinically significant cardiovascular disease Neurological syndromes, including multiple sclerosis, Alzheimer's disease, or Parkinson's disease Uncontrolled fibromyalgia History of left or right carotid surgery History of unilateral or bilateral vagotomy, partial or complete splenectomy Recurrent vasovagal syncope episodes Current, regular use of tobacco products Hypersensitivity/allergy to MRI contrast agents and/or unable to perform MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manager of Clinical Operations at SetPoint Medical
Phone
855-737-3872 (855RESETRA)
Email
vhaines@setpointmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Call Center for RESET-RA
Phone
855-737-3872 (855RESETRA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Tesser, MD
Organizational Affiliation
Arizona Arthritis and Rheumatology Research, P.C.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Richardson, MD PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Withdrawn
Facility Name
Arizona Arthritis ans Rheumatology Research, PPLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Clark
Email
melissa.clark@azarthritis.com
First Name & Middle Initial & Last Name & Degree
Nikila Kumar, MD
First Name & Middle Initial & Last Name & Degree
David Adelson, MD
Facility Name
Arizona Arthritis Rheumatology & Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Salazar
Email
brenda.salazar@azarthritis.com
First Name & Middle Initial & Last Name & Degree
John Tesser, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Ronecker, MD
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravathi Pillai
Email
revathi.pillai@azarthritis.com
First Name & Middle Initial & Last Name & Degree
Romy Cabacungan, MD
First Name & Middle Initial & Last Name & Degree
Jennifer Ronecker, MD
Facility Name
Medvin Clinical Research
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Rodriguez
Email
m.rodriguez@medvinresearch.com
First Name & Middle Initial & Last Name & Degree
Lupe Perez
Email
lupe@medvinresearch.com
First Name & Middle Initial & Last Name & Degree
Samy Metyas, MD
First Name & Middle Initial & Last Name & Degree
Warren Boling, MD
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amalia Ellis
Email
aellis@irclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Katheryn Castillo
Email
kcastillo@irclinicaltrials.com
First Name & Middle Initial & Last Name & Degree
Eric Lee, MD
First Name & Middle Initial & Last Name & Degree
Warren Boling, MD
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nereyda Negrete
Email
nereyda@medvinresearch.com
First Name & Middle Initial & Last Name & Degree
Vipul Vineet
Email
vipul@medvinresearch.com
First Name & Middle Initial & Last Name & Degree
Tien-I Karleen Su, MD
First Name & Middle Initial & Last Name & Degree
Warren Boling, MD
Facility Name
The Arthritis & Rheumatology Clinic of Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Gish
Email
mgish@tektonresearch.com
First Name & Middle Initial & Last Name & Degree
Michael Thakor, MD
First Name & Middle Initial & Last Name & Degree
Matthew Robertson, MD
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Stein
Email
jstein@stctrials.com
First Name & Middle Initial & Last Name & Degree
Judy Dalgin
Email
jdalgin@stctrials.com
First Name & Middle Initial & Last Name & Degree
Stuart Novack, MD
First Name & Middle Initial & Last Name & Degree
Ashesh Mehta, MD
Facility Name
Delaware Arthritis
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Townsend
Email
ptownsend@delawarearthritis.com
First Name & Middle Initial & Last Name & Degree
Jose Pando, MD
First Name & Middle Initial & Last Name & Degree
Howard M Eisenberg, MD
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odence DeLaRosa
Email
odcherub1@aol.com
First Name & Middle Initial & Last Name & Degree
Norman Gaylis, MD
First Name & Middle Initial & Last Name & Degree
Justin Sporrer, MD
Facility Name
HARAC Research Corporation
City
Avon Park
State/Province
Florida
ZIP/Postal Code
33825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulissa Peguero
Email
clinicaltrialexperts@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexander Torres, MD
First Name & Middle Initial & Last Name & Degree
Donald Sachs, MD
Facility Name
RecioMed Clinical Research Network, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Individual Site Status
Terminated
Facility Name
Bay Area Rheumatology
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorraine Androsiglio
Email
crclori@yahoo.com
First Name & Middle Initial & Last Name & Degree
Robert Levin, MD
First Name & Middle Initial & Last Name & Degree
Donald Sachs, MD
Facility Name
IRIS Research and Development
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Perez, MD
Email
kperez@valenzuelarheumatology.com
First Name & Middle Initial & Last Name & Degree
Guillermo Valenzuela, MD
First Name & Middle Initial & Last Name & Degree
Frank Vrionis, MD
Facility Name
West Broward Rheumatology Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Withdrawn
Facility Name
Florida Medical Clinic, LLC
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Individual Site Status
Withdrawn
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie England
Email
VENGLAND@augusta.edu
First Name & Middle Initial & Last Name & Degree
Elena Schiopu, MD
First Name & Middle Initial & Last Name & Degree
Fernando Vale, MD
Facility Name
Parris and Associates Rheumatology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mannai Countermarsh
Email
m.countermarsh@aara.care
First Name & Middle Initial & Last Name & Degree
Glenn Parris, MD
First Name & Middle Initial & Last Name & Degree
Said Elshihabi, MD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Callahan
Email
Thomas.Callahan@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Eric Ruderman, MD
First Name & Middle Initial & Last Name & Degree
Joshua Rosenow, MD
Facility Name
Hinsdale Orthopaedics Illinois Bone and Joint Institute
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lubna Ali
Email
Lali@ibji.com
First Name & Middle Initial & Last Name & Degree
Angela Crowley, MD
First Name & Middle Initial & Last Name & Degree
Nirav Thakkar, MD
Facility Name
Massachusetts General Hospital Division of Rheumatology, Allergy, and Immunology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amelia Cogan
Email
ascogan@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Minna Kohler, MD
First Name & Middle Initial & Last Name & Degree
Mark Richardson, MD
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohan Pahari
Email
Mohan.Pahari@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Kay, MD
First Name & Middle Initial & Last Name & Degree
Daniel Kim, MD
Facility Name
June DO, PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tresa Nelson
Email
tresa.nelson@glcor.com
First Name & Middle Initial & Last Name & Degree
Joshua June, DO
First Name & Middle Initial & Last Name & Degree
Jason Schwalb, MD
Facility Name
Saint Paul Rheumatology, P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Fabelo
Email
margarita@sprdrem.com
First Name & Middle Initial & Last Name & Degree
David Ridely, MD
First Name & Middle Initial & Last Name & Degree
Michael Park, MD
Facility Name
Kansas City Physician Partners
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micah Judd
Email
micah.judd@azarthritis.com
First Name & Middle Initial & Last Name & Degree
Tina Shah, MD
First Name & Middle Initial & Last Name & Degree
Nicholas Wirtz, MD
Facility Name
West County Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vick Katoch
Email
v.katoch@aara.care
First Name & Middle Initial & Last Name & Degree
Sona Kamat, MD
First Name & Middle Initial & Last Name & Degree
Richard Barnes, DO
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleece Reetz
Email
aleece.reetz@prc.us.com
First Name & Middle Initial & Last Name & Degree
Melvin Churchill, MD
First Name & Middle Initial & Last Name & Degree
Steven Gogela, MD
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Ramirez
Email
valarr@qwestoffice.net
First Name & Middle Initial & Last Name & Degree
Valarie Jackson
Email
vjackson@abqrheum.net
First Name & Middle Initial & Last Name & Degree
Leroy Pacheco, MD
First Name & Middle Initial & Last Name & Degree
James Botros, MD
Facility Name
Long Island Regional Arthritis & Osteoporosis Care
City
Babylon
State/Province
New York
ZIP/Postal Code
11702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Vuong, DO
Email
Victoria.chin@gmail.com
First Name & Middle Initial & Last Name & Degree
Victoria Vuong, DO
First Name & Middle Initial & Last Name & Degree
Ashesh Mehta, MD
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Droppelman
Email
Audrey.Droppelman@djlresearch.com
First Name & Middle Initial & Last Name & Degree
Jane Box, MD
First Name & Middle Initial & Last Name & Degree
Mark Van Poppel, MD
Facility Name
PMG Research
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Health Research of Oklahoma, PLLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Prescott
Email
cprescott@healthresearchok.com
First Name & Middle Initial & Last Name & Degree
Christine Codding, MD
First Name & Middle Initial & Last Name & Degree
Perry Santos, MD
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Karpowicz
Email
Matthew.Karpowicz@lvhn.org
First Name & Middle Initial & Last Name & Degree
Susan Kim, MD
First Name & Middle Initial & Last Name & Degree
Gregory Davis, MD
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Rosen
Email
ellenrosen@altoonaresearch.com
First Name & Middle Initial & Last Name & Degree
Alan J Kivitz, MD
First Name & Middle Initial & Last Name & Degree
Michael D Sather, MD
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana Bonilla
Email
Juliana.Bonilla1@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Joshua Baker, MD
First Name & Middle Initial & Last Name & Degree
Isaac Chen, MD
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Withdrawn
Facility Name
Arthritis & Rheumatology Research Institute, PLLC
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guadalupe Cindo
Email
l.cindo@dfwarthritis.com
First Name & Middle Initial & Last Name & Degree
Megha Patel-Banker, MD
First Name & Middle Initial & Last Name & Degree
Bradley Lega, MD
Facility Name
Austin Regional Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78717
Country
United States
Individual Site Status
Terminated
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Holleran
Email
jholleran@tektonresearch.com
First Name & Middle Initial & Last Name & Degree
Rita Yankyera
Email
ryankyera@tektonresearch.com
First Name & Middle Initial & Last Name & Degree
Paul Pickrell, MD
First Name & Middle Initial & Last Name & Degree
Daniel Peterson, MD
Facility Name
Central Texas Rheumatology Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Van Schouwen
Email
Kelly@researchtex.com
First Name & Middle Initial & Last Name & Degree
Monty Tew, MD
First Name & Middle Initial & Last Name & Degree
Daniel Peterson, MD
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venkata Sunkara
Email
venkatasunkara@pccrsolutions.com
First Name & Middle Initial & Last Name & Degree
Dhiman Basu, MD
First Name & Middle Initial & Last Name & Degree
Bradley Lega, MD
Facility Name
Biopharma Informatic
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Individual Site Status
Terminated
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Delacruz
Email
ndelacruz@swrr.net
First Name & Middle Initial & Last Name & Degree
Atul Singhal, MD
First Name & Middle Initial & Last Name & Degree
Bradley Lega, MD
Facility Name
Clinical Trials of Texas, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Korte
Email
mkorte@cttexas.com
First Name & Middle Initial & Last Name & Degree
Alison Mortensen
Email
amortensen@cttexas.com
First Name & Middle Initial & Last Name & Degree
Pendleton Wickersham, MD
First Name & Middle Initial & Last Name & Degree
Daniel Peterson, MD
Facility Name
Annapolis Rheumatology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latonia Fowler
Email
lfowler@arheum.com
First Name & Middle Initial & Last Name & Degree
Gineth Paola Pinto-Patarroyo, MD
First Name & Middle Initial & Last Name & Degree
Howard Eisenberg, MD
Facility Name
Sound Clinical Research, LLC
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aubrey Hubble
Email
ahubble@wwmedgroup.com
First Name & Middle Initial & Last Name & Degree
Jeff Peterson, MD
First Name & Middle Initial & Last Name & Degree
Andrew Ko, MD
Facility Name
Arthritis Northwest Rheumatology, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Withdrawn
Facility Name
University Physicians and Surgeons, INC dba Marshall Health
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Withdrawn
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Terminated

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing data is planned.

Learn more about this trial

Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis

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