Relatives of People with Diabetes: Age 6 to 45 Years with a Normal OGTT and Positive for 2 Antibodies
Drug Name: Abatacept
Study Name: CTLA-4 Ig (Abatacept) for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At-Risk for Type 1 Diabetes Mellitus
Study Sponsor: TrialNet
Principal Investigator: Stephen E. Gitelman, MD, Director, Pediatric Diabetes Program, UCSF
Who can sign up for this study?
- be a relative of someone with type 1 diabetes
- be between 6 and 45 years old
- be enrolled in the TrialNet Pathway to Prevention Study
- have had a normal OGTT and be positive for two autoantibodies, as determined in the Pathway to Prevention Study
What is this study about? The UCSF Pediatric Clinical Research Program is conducting a study to see if treatment with Abatacept will prevent or delay the development of type 1 diabetes in those who are at risk. Abatacept (also known as Orencia) is currently approved by the US Food and Drug Administration (FDA) for treatment of rheumatoid arthritis (which is an autoimmune disease, like type 1 diabetes). It is not approved for use in type 1 diabetes and is considered an investigational medication for this study. In a prior TrialNet study, subjects with newly diagnosed type 1 diabetes who received Abatacept kept producing their own insulin longer than people in the study who did not get Abatacept.
What will happen in this study? Volunteers who qualify and are enrolled will receive 14 doses of Abatacept or placebo over the course of 12 months. The Abatacept or placebo will be given through a vein (IV infusion) over 30 minutes. All volunteers will be monitored 1 to 5 years after the treatment period to assess their overall health and to determine the effects of the treatment to their immune system and beta cells. This will require several visits to UCSF for laboratory testing during this period.
How long will this study last? Each volunteer will be followed for 2 to 6 years. We anticipate that most volunteers will be followed for about 4 years.
Reimbursement: You will not be charged for any of the study treatments and will be paid for your time, effort and travel expenses.
For more information: Please contact Kathleen Fraser at 415-353-9084 or email@example.com.