Clinical Study Details
CTLA-4 Ig (Abatacept) FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN RELATIVES AT-RISK FOR TYPE 1 DIABETES MELLITUS
A study is being done to see if CTLA-4 (Abatacept) can delay or prevent the onset of type 1 diabetes in individuals identified as being at risk for developing the disease.
Recently, TrialNet tested abatacept in 112 people aged 6 to 45 who had recently been diagnosed with diabetes. The people in the study who got abatacept kept producing their own insulin longer than people in the study who did not get abatacept. The results were published in the medical journal The Lancet in 2011.
You (or your child) are eligible to be screened in the TrialNet Natural History to determine your risk of developing type 1 diabetes if you (or your child) are a first degree blood relative (sibling, child, or parent) between the ages of 1 and 45 years or a second degree relative (cousin, uncle, aunt, niece, nephew, grandparent, or half-sibling) between 1 and 20 years of age. Subjects in this study must be at least 6 years old.
The pathway in to this study is through the Pathway to Prevention study.
If you are in this study, you will get you will get study IV infusions: either abatacept or placebo, which will determined by chance. Neither you nor your study team will know which you are getting.
The infusions will happen at 0, 2, and 4 weeks following randomization, and then every 28+/-7 days) thereafter for a total of 14 doses. Close monitoring for diabetes development through the duration of study.
If you are interested in having either you or your child screened for the Natural History Study and potential eligibility for this study, please contact Trudy Esrey, 650-498-4450, email@example.com to discuss any questions you may have and to schedule a screening appointment.Please visit the TrialNet public website at http://www.diabetestrialnet.org
- Please review the consent form, as well as the TrialNet public website, for more information.
Screening Consent Form
- Intervention Consent Form
- Screening Assent Form for Ages 7-11
- Screening Assent Form for Ages 12-17
- Intervention Assent Form for Ages 7-11
- Intervention Assent Form for Ages 12-17
TrialNet public website at http://www.diabetestrialnet.org