Rituximab in New Onset Type 1 Diabetes (TN05)
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Newly diagnosed type 1 diabetes, New Onset type 1 diabetes, Preservation of insulin secretion, Type 1 diabetes, Juvenile Onset Diabetes, Insulin Dependent Diabetes, T1D
Eligibility Criteria
Inclusion Criteria: Between the ages of 8 and 45 years Within 3 months of diagnosis of type 1 diabetes Have presence of at least one diabetes-related autoantibody Must have stimulated C-peptide levels of at least 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) within one month of randomization If female with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing while participating in the study Have not received an immunization for at least one month Must be willing to comply with intensive diabetes management Must weigh at least 25 kg at study entry Exclusion Criteria: Are immunodeficient or have clinically significant chronic lymphopenia Have an active infection or positive purified protein derivative (PPD) test result Currently pregnant or lactating; or anticipate becoming pregnant. Require chronic use of steroids Have current or past HIV, hepatitis B, or hepatitis C infection Have any complicating medical issues that interfere with study conduct or cause increased risk Have a history of malignancies Currently using non-insulin pharmaceuticals that effect glycemic control Currently participating in another type 1 diabetes treatment study
Sites / Locations
- Childrens Hospital of Los Angeles
- University of California-San Francisco
- Stanford University
- Barbara Davis Center for Childhood Diabetes
- University of Florida
- University of Miami
- Indiana University-Riley Hospital for Children
- Joslin
- University of Minnesota
- Columbia University
- University of Pittsburgh
- University of Texas
- Benaroya Research Institute
- Walter and Eliza Hall Institute of Medical Research
- The Hospital for Sick Children
- San Raffaele Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rituximab Intravenous Infusion
Placebo Intravenous Infusion
Participants will receive active rituximab (anti-CD20 monoclonal antibody) as an intravenous infusion, with 4 administrations at weeks 0, 1, 2, and 3 at a dose of 375mg/m2
Participants will receive placebo given as an intravenous infusion with 4 administrations at weeks 0, 1, 2, and 3.