| Eligibility |
Inclusion Criteria:
Potential participants must meet all of the following inclusion criteria:
1. Age > 3 and < 46 years
2. Willing to provide Informed Consent or have a parent or legal guardian provide
informed consent if the subject is <18 years of age
3. At least two or more diabetes-related biochemical autoantibodies insulin (mIAA),
glutamic acid decarboxylase antibody (GADA), Islet cytoplasmic antibodies (ICA), islet
antigen 2 (IA-2A), zinc transporter 8 (ZnT8A) present on the same sample. Of note, ICA
and GADA positivity alone cannot be used to define eligibility in this trial).
4. Must have at least two of the high-risk markers defined below (within 7 weeks (52
days) of screening visit if performed as part of TN01 Pathway to Prevention (PTP)
study at time of screening; defining a 50% two-year progression risk):
a. Abnormal glucose tolerance: i. 2-hr glucose = 140 and <200 mg/dL, fasting glucose =
110 and <126, or 30-, 60-, or 90-minute glucose = 200 mg/dL b. HbA1c = 5.7 c. Index60
= 1.4 d. Diabetes Prevention Trial-Type 1 Risk Score (DPTRS) = 7.4
5. Females of childbearing potential must agree to use abstinence or an effective birth
control through the treatment period.(
6. Males able to father children, must agree to use abstinence or an effective birth
control during the treatment period.
7. Subjects who are Epstein-Barr virus (EBV) seronegative at screening must be EBV
Polymerase chain reaction (PCR) negative within 30 days of randomization and may not
have had signs or symptoms of an EBV compatible illness lasting longer than 7 days
within 30 days of randomization
8. Be at least 4 weeks from last live immunization
9. Be willing to forgo live vaccines through and 3 months after study drug treatment
period
10. Be up to date on all recommended vaccinations based on age of subject and willing to
receive killed influenza vaccine when available for current or upcoming season.
11. If prior treatment with active study agent from previous clinical trial, approval of
medical monitor and investigator that such prior treatment does not impact risk for
current study.
12. Subjects who have met all above criteria must have the qualifying oral glucose
tolerance test (OGTT) within 7 weeks (52 days) of randomization and baseline visit.
Exclusion Criteria:
Potential participants must not meet any of the following exclusion criteria:
- 1. Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia
(< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800
lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL).
2. Have active signs or symptoms of acute infection at the time of randomization
including Sars-Cov2.
3. Have evidence of prior or current tuberculosis infection as assessed interferon
gamma release assay (QuantiFERON).
4. Be currently pregnant or lactating, or anticipate getting pregnant within the study
period
5. Require chronic use of other immunosuppressive agents including use of inhaled,
intranasal, or systemic steroids
6. Have evidence of current or past HIV, Hepatitis B, histoplasmosis,
coccidioidomycosis, or current Hepatitis C infection.
7. Have any complicating medical issues or abnormal clinical laboratory results that
may interfere with study conduct, or cause increased risk to include pre-existing
pulmonary, GI, renal, cardio-vascular disease, neurological disease (i.e.
demyelinating disease), psychiatric disease or blood count abnormalities. Note
pre-existing treated celiac or thyroid disease are not exclusionary diagnoses.
8. Have a history of malignancies other than of skin
9. Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) greater than 2 times the upper limits of normal
10. Evidence of renal dysfunction with creatinine greater than 1.5 times the upper
limit of normal for age and sex.
11. Known history of congestive heart failure or left ventricular dysfunction.
12. Vaccination with a live virus within the last 4 weeks
13. Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control
within 30 days of screening (see section 4.5 for list of exclusionary
pharmaceuticals).
14. Active participation in another intervention study in the previous 30 days
15. Known allergy to Anti-TNFa or latex.
16. Any condition that in the investigator's opinion may adversely affect study
participation or may compromise the study results
17. Previously diagnosed with T1D according to American Diabetes Association (ADA)
criteria
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