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Information for Study Participants
CTLA-4 Ig (Abatacept) in Prevention of Diabetes
You can get screened for the Abatacept Prevention Study, if:
About this Study
If anyone in your family has type 1 diabetes, you and other family members may be at risk. A major goal of TrialNet is to find a way to delay or prevent diabetes in those at risk.
Type 1 diabetes is an autoimmune disease. The immune system attacks and destroys the insulin-producing cells in the body, called beta cells. Beta cell destruction starts years before an individual shows any symptoms of diabetes.
TrialNet offers a screening at no charge to family members of people with type 1 diabetes to determine individual risk. This test can identify risk up to 10 years before symptoms appear.
Abatacept (Orencia®) was first approved by the U.S. Food and Drug Administration (FDA) in 2005 for treatment of other autoimmune diseases, including rheumatoid arthritis. It has also shown promise in preserving insulin production in people newly diagnosed with type 1 diabetes.
In a prior study, TrialNet tested abatacept in individuals recently diagnosed with type 1 diabetes. Those who got abatacept continued to produce insulin longer than people who did not. Based on these findings (published June, 2011 in the medical journal, The Lancet), TrialNet is now testing abatacept in persons determined to be at risk, but not yet diagnosed, to see if it can help delay or prevent the onset of type 1 diabetes.
At present, there is no approved treatment to stop the immune system before it destroys all of a person's beta cells. That is the goal of this study - to see if the drug abatacept can stop or slow down beta cell destruction in people who are at moderate risk of developing type 1 diabetes over the next 5 years.
What will I be asked to do?
If you join this study, you will visit a TrialNet site to receive a total of 14 infusions given over one year. These infusions will be given three times (every two weeks) during the first month, then monthly the rest of the year. Each infusion takes about 30 minutes and is followed by a 1-hour observation period. After completing the treatment phase of the study, you will return for follow-up tests and monitoring every 6 months.
A computer will randomly choose which group you are in. It's by chance, like flipping a coin. While the study is going on, neither you nor your study team will know if you're in the treatment group or the control group. At the end of the study, we will tell you which group you were in.
As a research volunteer, you can decide to stop being in this study at any time. We hope you will stay in the study. You will be helping us learn how to help people at risk for type 1 diabetes.
To see if you might be eligible for this study and for a referral to a TrialNet site:
Information will be kept confidential.