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Transcutaneous Vagus Nerve Stimulation (tcVNS) in JIA (AJA01)

Primary Purpose

Juvenile Idiopathic Arthritis (JIA)

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Active tcVNS or Sham tcVNS
Active tcVNS
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis (JIA) focused on measuring Juvenile Idiopathic Arthritis, JIA, Children, tcVNS, Cytokines, Inflammation, Nonsignificant risk, NSR

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant is 5 through 18 years of age (inclusive) at screening. Regarding informed consent and compliance: If 5 through 6 years of age, the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. If 7 through 17 years of age, the participant is willing and able to sign assent and comply with study protocol, and the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. If 18 years of age, the participant is willing and able to understand and provide informed consent and comply with study protocol. The participant has a Juvenile Idiopathic Arthritis (JIA) diagnosis meeting International League of Associations for Rheumatology (ILAR) classification criteria with one of the following subtypes: rheumatoid-factor negative polyarthritis rheumatoid-factor positive polyarthritis persistent oligoarthritis extended oligoarthritis psoriatic arthritis enthesitis-related arthritis systemic arthritis The participant has >=3 joints with active arthritis at screening If the participant is receiving therapy for JIA at screening, that therapy is stable for the time period outlined below and is expected to remain stable for the duration of the study: a. stable dose for at least 1 week prior to screening: i. Oral steroids, <= 0.2 mg/kg/day with a maximum 10 mg/day dose b. stable dose for at least 8 weeks prior to screening i. adalimumab ii. anakinra iii. canakinumab iv. certolizumab pegol v. etanercept vi. golimumab vii. infliximab viii. leflunomide ix. methotrexate x. tocilizumab c. stable dose for at least 12 weeks prior to screening: i. abatacept If a female of child-bearing potential, the participant has a negative urine pregnancy test at screening If of reproductive potential, must agree to abstinence or effective methods of birth control for the duration of the study Exclusion Criteria: Participant has been treated for JIA with more than 2 therapies, other than NSAIDs or intra-articular injections, with lack of efficacy. Participant has received high-dose steroids (>=0.2 mg/kg/day) within the 28 days prior to screening. Participant has had active systemic disease (fever, systemic rash) within the 3 months prior to screening including any of the following lab manifestations at screening: Ferritin >1000 ng/mL White blood cell (WBC) ≥15,000/mm^3 Participant has had an active acute infection within 2 weeks of screening. Participant has a history of arrhythmia. Participant has been diagnosed with postural orthostatic tachycardia syndrome (POTS). Participant has received an intra-articular cortisone injection within the 28 days prior to screening. Participant has received treatment with an investigational drug or device during the 28 days prior to screening or within five half-lives of the investigational drug prior to screening/baseline, whichever is the greater length of time. Participant has received chronic treatment with an anti-cholinergic medication, including over the counter medications. Participant has received treatment with rituximab: Within one year of screening At any time previously without documented B cell repletion Participant has a comorbid disease that has required treatment with corticosteroids within the past year. Participant has an implantable electronic device such as a pacemaker, defibrillator, hearing aid, cochlear implant, insulin pump or deep brain stimulator. Participant has used cutaneous vagus nerve stimulation within 12 weeks prior to screening. Participant has received a live attenuated viral vaccine within 28 days prior to screening or is expected to receive one during the study. Participant has any condition which, in the opinion of the investigator, would jeopardize the participant's safety following exposure to a study intervention. Participant has any past or current medical problems or findings from a physical examination or laboratory testing that are not listed above but which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.

Sites / Locations

  • University of California San FranciscoRecruiting
  • Nemours Children's Health: Department of Pediatric Rheumatology
  • Emory University, Children's Healthcare of Atlanta- Center for Advanced Pediatrics: Division of Rheumatology
  • University of Chicago, Comer Children's Hospital
  • Indiana UniversityRecruiting
  • Cohen Children's Medical Center, Northwell HealthRecruiting
  • Hassenfield Children's Hospital at NYU Langone
  • Hospital for Special SurgeryRecruiting
  • University of Pittsburgh
  • Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blinded phase

Open-Label phase

Arm Description

Participants will receive 5 minutes of active tcVNS or sham tcVNS daily for 8 weeks.

Participants will receive 5 minutes of stimulation via the active tcVNS for 8 weeks after a double-blind, sham-controlled 8- week period.

Outcomes

Primary Outcome Measures

The proportion of participants achieving >= 50 percent improvement in clinical status as defined by JIA ACR 50
This primary endpoint will be compared between the active tcVNS and Sham tcVNS treatment arms. The Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis number of joints with limited motion physician's assessment of disease activity (measured on a 10 cm visual analog scale) parent/patient assessment of overall well-being (measured on a 10 cm visual analog scale) a validated measure of physical function Childhood Health Assessment Questionnaire (CHAQ) a laboratory measure of inflammation c-Reactive Protein (CRP) The JIA ACR 50 is achieved if 3 of any 6 core set variables improve by at least 50 percent from baseline or Day 0 visit, and no more than 1 variable worsening by >30 percent

Secondary Outcome Measures

Day 0 as the baseline: The proportion of participants achieving a JIA ACR 50 response
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 30 response
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 70 response
Day 0 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 50 response
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 30 response
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 70 response
Week 8 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Longitudinal trends in Juvenile Arthritis Disease Activity Score-27 (JADAS-27)
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Incidence of Adverse Events (AEs) and Severe Adverse Events (SAEs)

Full Information

First Posted
January 12, 2023
Last Updated
October 10, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Autoimmunity Centers of Excellence (ACE), Feinstein Institute for Medical Research (FIMR)
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1. Study Identification

Unique Protocol Identification Number
NCT05710640
Brief Title
Transcutaneous Vagus Nerve Stimulation (tcVNS) in JIA
Acronym
AJA01
Official Title
Using the Cholinergic Anti-Inflammatory Pathway to Treat Juvenile Idiopathic Arthritis (AJA01)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Autoimmunity Centers of Excellence (ACE), Feinstein Institute for Medical Research (FIMR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is a multicenter, double-blind, sham-controlled trial to evaluate the safety and effectiveness of tcVNS on pain and inflammation associated with JIA. tcVNS is administered with a device that gives off mild electrical impulses through the skin to stimulate the vagus nerve. Part of the vagus nerve and its branches are located in the head and neck. For this study, the impulses will be administered in areas overlying the vagus nerve using a small electrode. The electrode helps to conduct the stimulation through the skin. This stimulation triggers a chemical response through the nerves and has been found to be effective in reducing pain and inflammation in several diseases. The primary objective of this study is to determine the effect of tcVNS on JIA ACR 50 in participants with active JIA. The components of the active and sham tcVNS devices, utilizing the Roscoe Medical TENS 7000, have been FDA 510(k)-cleared and have been determined by the IRB to be a nonsignificant risk device.
Detailed Description
AJA01 is a multicenter, double-blind, sham-controlled, 16-week trial to evaluate the safety and effectiveness of tcVNS for the treatment of JIA. A total of 100 participants will be randomized 1:1 to treatment with active tcVNS or sham tcVNS for 5 minutes once a day for 8 weeks. During this time, participants/parents, and participant assessors will be blinded to treatment assignment; treatments on clinic visit days will be conducted in the clinic under the supervision of a trained, unblinded staff member, and participants will only discuss the stimulation procedure with this staff member. An unblinded site investigator will follow up on any safety events. The double-blind, sham-controlled 8-week period will be followed by an 8-week open-label period in which all participants will receive treatment with active tcVNS once a day for 5 minutes. Participants and their parents will be told it is likely they will feel the stimulation, but it should not be painful. There are 10 visits for the study, 8 clinic visits and 2 tele-visits. Participants will have physical exams with joint assessments, lab tests, and questionnaire completion by the physicians and participants at each clinic visit. Participants will be trained by the unblinded coordinator to perform stimulation during the clinic visit following the randomization. Participants will perform the stimulation at home for 5 minutes daily. Participants will complete a diary to document the daily stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis (JIA)
Keywords
Juvenile Idiopathic Arthritis, JIA, Children, tcVNS, Cytokines, Inflammation, Nonsignificant risk, NSR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blinded phase
Arm Type
Experimental
Arm Description
Participants will receive 5 minutes of active tcVNS or sham tcVNS daily for 8 weeks.
Arm Title
Open-Label phase
Arm Type
Experimental
Arm Description
Participants will receive 5 minutes of stimulation via the active tcVNS for 8 weeks after a double-blind, sham-controlled 8- week period.
Intervention Type
Device
Intervention Name(s)
Active tcVNS or Sham tcVNS
Other Intervention Name(s)
tVNS
Intervention Description
tcVNS is administered with a study device that gives off mild electrical impulses through the skin to stimulate the vagus nerve (a nerve that travels underneath the skin in your neck and head). This stimulation triggers a chemical response through the nerves and has been found to be effective in reducing pain and inflammation in several diseases.
Intervention Type
Device
Intervention Name(s)
Active tcVNS
Other Intervention Name(s)
tVNS
Intervention Description
tcVNS is administered with a study device that gives off mild electrical impulses through the skin to stimulate the vagus nerve (a nerve that travels underneath the skin in your neck and head). This stimulation triggers a chemical response through the nerves and has been found to be effective in reducing pain and inflammation in several diseases.
Primary Outcome Measure Information:
Title
The proportion of participants achieving >= 50 percent improvement in clinical status as defined by JIA ACR 50
Description
This primary endpoint will be compared between the active tcVNS and Sham tcVNS treatment arms. The Juvenile Idiopathic Arthritis American College of Rheumatology (JIA ACR) 50 is a validated composite response consisting of 6 core criteria: number of joints with active arthritis number of joints with limited motion physician's assessment of disease activity (measured on a 10 cm visual analog scale) parent/patient assessment of overall well-being (measured on a 10 cm visual analog scale) a validated measure of physical function Childhood Health Assessment Questionnaire (CHAQ) a laboratory measure of inflammation c-Reactive Protein (CRP) The JIA ACR 50 is achieved if 3 of any 6 core set variables improve by at least 50 percent from baseline or Day 0 visit, and no more than 1 variable worsening by >30 percent
Time Frame
At Week 8
Secondary Outcome Measure Information:
Title
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 50 response
Time Frame
At Weeks 4, 12, and 16
Title
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 30 response
Time Frame
At Weeks 4, 8, 12, and 16
Title
Day 0 as the baseline: The proportion of participants achieving a JIA ACR 70 response
Time Frame
At Weeks 4, 8, 12, and 16
Title
Day 0 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
Description
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame
At Weeks 4, 8, 12, and 16
Title
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 50 response
Time Frame
At Weeks 12 and 16
Title
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 30 response
Time Frame
At Weeks 12 and 16
Title
Week 8 as the baseline: The proportion of participants achieving a JIA ACR 70 response
Time Frame
At Weeks 12 and 16
Title
Week 8 as the baseline: The change in Juvenile Disease Activity Score-27 (JADAS-27)
Description
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame
At Weeks 12, and 16
Title
Longitudinal trends in Juvenile Arthritis Disease Activity Score-27 (JADAS-27)
Description
JADAS-27 is a validated composite disease activity measure for JIA. The JADAS-27 score was derived from four components; 1) Physician Global Assessment of Disease Activity (assessed on a VAS of 0 [no activity] to 10 [extreme activity]), 2) Parent/Patient Global Assessment (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease, 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.
Time Frame
From Day 0 to Week 16
Title
Incidence of Adverse Events (AEs) and Severe Adverse Events (SAEs)
Time Frame
From Day 0 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is 5 through 18 years of age (inclusive) at screening. Regarding informed consent and compliance: If 5 through 6 years of age, the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. If 7 through 17 years of age, the participant is willing and able to sign assent and comply with study protocol, and the participant's guardian is willing and able to understand and provide informed consent and comply with study protocol. If 18 years of age, the participant is willing and able to understand and provide informed consent and comply with study protocol. The participant has a Juvenile Idiopathic Arthritis (JIA) diagnosis meeting International League of Associations for Rheumatology (ILAR) classification criteria with one of the following subtypes: rheumatoid-factor negative polyarthritis rheumatoid-factor positive polyarthritis persistent oligoarthritis extended oligoarthritis psoriatic arthritis enthesitis-related arthritis systemic arthritis The participant has >=3 joints with active arthritis at screening If the participant is receiving therapy for JIA at screening, that therapy is stable for the time period outlined below and is expected to remain stable for the duration of the study: a. stable dose for at least 1 week prior to screening: i. Oral steroids, <= 0.2 mg/kg/day with a maximum 10 mg/day dose b. stable dose for at least 8 weeks prior to screening i. adalimumab ii. anakinra iii. canakinumab iv. certolizumab pegol v. etanercept vi. golimumab vii. infliximab viii. leflunomide ix. methotrexate x. tocilizumab c. stable dose for at least 12 weeks prior to screening: i. abatacept If a female of child-bearing potential, the participant has a negative urine pregnancy test at screening If of reproductive potential, must agree to abstinence or effective methods of birth control for the duration of the study Exclusion Criteria: Participant has been treated for JIA with more than 2 therapies, other than NSAIDs or intra-articular injections, with lack of efficacy. Participant has received high-dose steroids (>=0.2 mg/kg/day) within the 28 days prior to screening. Participant has had active systemic disease (fever, systemic rash) within the 3 months prior to screening including any of the following lab manifestations at screening: Ferritin >1000 ng/mL White blood cell (WBC) ≥15,000/mm^3 Participant has had an active acute infection within 2 weeks of screening. Participant has a history of arrhythmia. Participant has been diagnosed with postural orthostatic tachycardia syndrome (POTS). Participant has received an intra-articular cortisone injection within the 28 days prior to screening. Participant has received treatment with an investigational drug or device during the 28 days prior to screening or within five half-lives of the investigational drug prior to screening/baseline, whichever is the greater length of time. Participant has received chronic treatment with an anti-cholinergic medication, including over the counter medications. Participant has received treatment with rituximab: Within one year of screening At any time previously without documented B cell repletion Participant has a comorbid disease that has required treatment with corticosteroids within the past year. Participant has an implantable electronic device such as a pacemaker, defibrillator, hearing aid, cochlear implant, insulin pump or deep brain stimulator. Participant has used cutaneous vagus nerve stimulation within 12 weeks prior to screening. Participant has received a live attenuated viral vaccine within 28 days prior to screening or is expected to receive one during the study. Participant has any condition which, in the opinion of the investigator, would jeopardize the participant's safety following exposure to a study intervention. Participant has any past or current medical problems or findings from a physical examination or laboratory testing that are not listed above but which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Gottlieb
Organizational Affiliation
Feinstein Institutes for Medical Research, Cohen Children's Medical Center: Pediatric Rheumatology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cynthia Aranow, MD
Organizational Affiliation
Feinstein Institutes for Medical Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timir Datta-Chaudhuri, PhD
Organizational Affiliation
Feinstein Institutes for Medical Research
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Betty Diamond, MD
Organizational Affiliation
Feinstein Institutes for Medical Research
Official's Role
Study Chair
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zilan Zheng
Phone
415-353-1301
Email
zilan.zheng@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Susan Kim, MD
Facility Name
Nemours Children's Health: Department of Pediatric Rheumatology
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Toth, MD
Facility Name
Emory University, Children's Healthcare of Atlanta- Center for Advanced Pediatrics: Division of Rheumatology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sampath Prahalad, MD
Facility Name
University of Chicago, Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Tesher, MD
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Rakestraw
Phone
317-274-2172
Email
arakestr@iu.edu
First Name & Middle Initial & Last Name & Degree
Stacey Tarvin, MD
Facility Name
Cohen Children's Medical Center, Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Machado
Phone
516-472-3711
Email
amachado3@northwell.edu
First Name & Middle Initial & Last Name & Degree
Beth Gottlieb, MD
Facility Name
Hassenfield Children's Hospital at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Kahn
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Klauss
Phone
212-774-2703
Email
klaussj@HSS.EDU
First Name & Middle Initial & Last Name & Degree
Karen Onel, MD
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margalit Rosenkranz, MD
Facility Name
Division of Pediatric Rheumatology at the University of Utah School of Medicine and Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Hersh
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nidhi Naik
Phone
206-987-5149
Email
Nidhi.Naik@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Esi Morgan, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The plan is to share data upon completion of the study in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from the Division of Allergy Immunology and Transplantation-funded grants and contracts.
IPD Sharing Time Frame
On average, within 24 months after database lock for the trial.
IPD Sharing Access Criteria
Open access.
IPD Sharing URL
https://www.immport.org/home
Links:
URL
https://www.autoimmunitycenters.org/
Description
Autoimmunity Centers of Excellence (ACE)
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)

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Transcutaneous Vagus Nerve Stimulation (tcVNS) in JIA

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