Anti-CD3 (Teplizumab) Prevention Study
Study Name: AntiCD3 MAB (Teplizumab) for Prevention of Diabetes in Relatives At-Risk for Type 1 Diabetes Mellitus
Principal Investigator: Desmond Schatz, MD
Coordinator: P.D. Towe, RN
What is the AntiCD3 Prevention Study?
TrialNet is now testing to see if an experimental medication called teplizumab may stop or slow down the autoimmune reaction that is destroying beta cells in people who are at high risk of developing type 1 diabetes. This research study will compare participants who get the experimental treatment with those who do not.
Who can participate?
Participants in the TrialNet Natural History Pathway to Prevetion Study that have at least two positive autoantibodies and abnormal glucose tolerance will qualify to be screened for the AntiCD3 Prevention Study.
What will study participants be asked to do?
The screening visit will occur at the University of Florida and will include blood tests to determine eligibility for this study.
If the results from this screening visit show the participant is eligible to be in the study they will be referred to the closest TrialNet Center for the infusion part of this study.
Half the participants will receive Teplizumab, half will receive a placebo.
Once the 14 day cycle of infusion is complete they will then return to the University of Florida for the follow up visits.
Informed Consent Form available upon request