10 Feb TrialNet: CTLA-4 lg (Abatacept) in Prevention of Type 1 Diabetes in Relatives “At-Risk”
About this Study
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.
You can get screened for the Abatacept Prevention Study, if:
- You are referred from TrialNet’s Pathway to Prevention Study
- You are at least 6 years old
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.
- Half of the study participants will get infusions of abatacept. This is the treatment group.
- Half of the study participants will get infusions of placebo (an inactive, harmless substance that looks just like the study drug). This is the control group.
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.
How to participate
If you have questions about the study or are interested in participating, please contact Gail at firstname.lastname@example.org.