Gender
All
Age Group
5 Years to 18 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Participant is 5 through 18 years of age (inclusive) at screening.
2. Regarding informed consent and compliance:
1. 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.
2. 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.
3. If 18 years of age, the participant is willing and able to understand and
provide informed consent and comply with study protocol.
3. 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:
1. rheumatoid-factor negative polyarthritis
2. rheumatoid-factor positive polyarthritis
3. persistent oligoarthritis
4. extended oligoarthritis
5. psoriatic arthritis
6. enthesitis-related arthritis
7. systemic arthritis
4. The participant has >=3 joints with active arthritis at screening
5. 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 2 weeks prior to screening: i. NSAIDs
c. 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
d. stable dose for at least 12 weeks prior to screening: i. abatacept
6. If a female of child-bearing potential, the participant has a negative urine
pregnancy test at screening
7. If of reproductive potential, must agree to abstinence or effective methods of birth
control for the duration of the study
Exclusion Criteria:
1. Other than NSAIDs or intra-articular injections, participant has been treated for
JIA with lack of efficacy with:
1. More than 2 different classes of therapies, or
2. More than 3 medications in total
2. Participant has received high-dose steroids (>=0.2 mg/kg/day) within the 28 days
prior to screening.
3. 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:
1. Ferritin >1000 ng/mL
2. White blood cell (WBC) ≥15,000/mm^3
4. Participant has had an active acute systemic infection within 2 weeks of screening.
involving fever (100.4â°F or higher) for more than 24 hours, requirement for systemic
antibiotics or antivirals, GI symptoms lasting 48 hours or more, or the need to hold
second line medications for JIA (methotrexate or biologic).
5. Participant has a history of arrhythmia.
6. Participant has been diagnosed with postural orthostatic tachycardia syndrome
(POTS).
7. Participant has received an intra-articular cortisone injection within the 28 days
prior to screening.
8. 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.
9. Participant has received chronic treatment with an anti-cholinergic medication,
including over the counter medications.
10. Participant has received treatment with rituximab:
1. Within one year of screening
2. At any time previously without documented B cell repletion
11. Participant has a comorbid disease that has required treatment with corticosteroids
within the past year.
12. Participant has an implantable electronic device such as a pacemaker, defibrillator,
hearing aid, cochlear implant, insulin pump or deep brain stimulator.
13. Participant has used cutaneous vagus nerve stimulation within 12 weeks prior to
screening.
14. Participant has received a live attenuated viral vaccine within 28 days prior to
screening or is expected to receive one during the study.
15. Participant has any condition which, in the opinion of the investigator, would
jeopardize the participant's safety following exposure to a study intervention.
16. 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.
