T1D RELAY

16 Apr T1D RELAY

TrialNet is testing rituximab-pvvr and abatacept, one after the other, to learn if using both treatments extend insulin production in people (ages 8-45) who were newly diagnosed with type 1 diabetes (T1D). Each therapy has a history of safety and effectiveness. Rituximab-pvvr is FDA-approved to treat several autoimmune diseases, including Rheumatoid Arthritis (RA). Abatacept is FDA-approved to treat adult Rheumatoid Arthritis, as well as Juvenile Idiopathic Arthritis (JIA) in children as young as six.

Recent findings from the TrialNet Abatacept Prevention Study (March 2023) showed that abatacept impacted immune response and preserved insulin production during the one-year treatment period. However, it did not meet the study’s goal of delaying progression from stage 1 to stage 2 T1D (the last stage before diagnosis).

While this is the first T1D study to test rituximab-pvvr followed by abatacept, this sequence is used by clinicians to treat other autoimmune diseases. By adding abatacept after rituximab-pvvr, researchers predict more people with T1D will experience prolonged beta cell function during and possibly after treatment.

The T1D RELAY study will enroll 74 people newly diagnosed with T1D. All participants will get four weekly intravenous (IV) infusions of rituximab-pvvr. Then, after 12 weeks of no treatment, everyone will receive weekly injections (self-administered) of abatacept or placebo for 20 months. Two-thirds of participants will get abatacept; one third will get placebo. All participants will receive intensive diabetes management during, between, and after treatments.

https://trialnet.org/our-research/newly-diagnosed-t1d/t1d-relay

Participant Eligibility

This study is enrolling people who are:

-Age 8-45
-Newly diagnosed with T1D (in past 3 months)
-Up to date on required vaccines (including the flu vaccine when it is available)
-Not pregnant, breastfeeding or planning to become pregnant while in the study

AND have:

-One or more diabetes-related autoantibodies
-C-peptide detectable during a mixed-meal tolerance test (MMTT)

These are the study’s main eligibility criteria. A member of your research team will review the full list of inclusion and exclusion criteria with you prior to your screening visit.

Contact

the BRI Outreach Team
(800) 888-4187