T1D RELAY Study - Parent of a child 8-17 years

STUDY BASICS

Are you the parent of a child 8 - 17 that is newly diagnosed with type 1 diabetes? Your child may be eligible for a research study to see if the use of two drugs-rituximab-pvvr followed by abatacept will help to preserve remaining insulin in people with newly diagnosed diabetes. Participation involves 21 visits over 4 years. Compensation is provided.

STUDY PURPOSE

The purpose is to study the use of rituximab-pvvr and abatacept, one after the other, to learn if using both treatments extend insulin production in people newly diagnosed with type 1 diabetes (T1D). Each participant will receive the rituximab-pvvr but then randomized to either abatacept or placebo.

COULD THIS STUDY BE RIGHT FOR YOU?

Parent of a child:

• Age 8 to 17
• Newly diagnosed with type 1 diabetes (less than 3 months ago)

WHAT PARTICIPANTS CAN EXPECT

All participants will receive investigational treatment of either rituximab-pvvr followed by abatacept or rituximab-pvvr followed by placebo.

Schedule of Visits

• Screening Visit
• Treatment Phase – 15 visits over about 24 months
• Follow-Up Phase – 5 visits over about 24 months