Status:
COMPLETED
Tocilizumab (TCZ) in New-onset Type 1 Diabetes
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
PPD Development, LP
Conditions:
Type 1 Diabetes Mellitus
New-onset Type 1 Diabetes Mellitus
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease. Based on previous research, study doctors think that giving medicines to affect the immune system soon after diabetes is diagnosed may stop, d...
Detailed Description
Staggered enrollment is planned for this trial. Prior to initiating the study in the pediatric age group (6-17 years old), 30-99 eligible adults (ages 18-45 years) will be randomized 2:1 to tocilizum...
Eligibility Criteria
Inclusion
- Male or female aged 6-45 years\*
- \*Current Institutional Review Board (IRB)-approved age eligibility criteria is restricted to subjects 6 to 17 years of age at time of study enrollment
- Diagnosis of type 1 diabetes mellitus (T1DM), using the American Diabetes Association T1DM criteria, within 100 days of study enrollment
- Positive for at least one diabetes-related autoantibody, including but not limited to:
- Glutamate decarboxylase (GAD-65)
- Insulin, if obtained within 10 days of the onset of exogenous insulin therapy
- Insulinoma antigen-2 (IA-2)
- Zinc transporter-8 (ZnT8)
- Peak stimulated C-peptide level ≥ 0.2 pmol/mL following a mixed-meal tolerance test (MMTT) conducted at least 21 days from diagnosis and within 37 days of randomization (V0)
- Signed informed consent (and informed assent of minor, if applicable).
Exclusion
- Severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies
- History of malignancy or serious uncontrolled cardiovascular, nervous system, pulmonary, renal, or gastrointestinal disease, or significant dyslipidemia
- Any history of recent serious bacterial, viral, fungal, or other opportunistic infections
- Have serologic evidence of current or past HIV (Human immunodeficiency virus), Hepatitis B, or Hepatitis C
- Positive QuantiFERON Tuberculosis (TB) test, history of TB, or active TB infection
- Active infection with Epstein-Barr virus (EBV) as defined by EBV viral load ≥10,000 copies per mL of whole blood
- Active infection with Cytomegalovirus (CMV) as defined by CMV viral load ≥10,000 copies per mL of whole blood
- Diagnosis of liver disease or elevated hepatic enzymes, as defined by Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or both \> 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin \> ULN
- Current or prior treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status
- Current or prior (within last 30 days) use of drugs other than insulin to treat hyperglycemia (e.g. metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, Dipeptidyl peptidase-4 Intravenous (DPP-IV) inhibitors, or amylin)
- Current use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin)
- Any of the following hematologic abnormalities, confirmed by repeat tests:
- White blood count \<3,000/microL or \>14,000/microL
- Lymphocyte count \<500/microL
- Platelet count \<150,000 /microL
- Hemoglobin \<8.5 g/dL
- . Neutrophil count \<2,000 cells/microL.
- Females who are pregnant, lactating, or planning on pregnancy during the 2- year study period
- History or diagnoses of other autoimmune diseases with the exception of stable thyroid or celiac disease
- History of alcohol, drug or chemical abuse within 1 year prior to study eligibility screening evaluation
- Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial
- Prior participation in a clinical trial that could increase risks associated with this clinical trial
- Receipt of live vaccine (e.g. varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and small pox) in the 6 weeks before randomization
- High lipid levels (fasting Low-density lipoprotein (LDL) cholesterol ≥160 mg/dL)
- History of significant allergy (e.g. anaphylaxis) to milk or soy proteins.
Key Trial Info
Start Date :
March 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT02293837
Start Date
March 12 2015
End Date
August 31 2020
Last Update
September 8 2021
Active Locations (19)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Stanford University
Stanford, California, United States, 94305
3
Yale University School of Medicine: Diabetes Endocrinology Research Center
New Haven, Connecticut, United States, 06519
4
University of Florida
Gainesville, Florida, United States, 32610