T1D RELAY – Rituximab-pvvr and Abatacept Newly Diagnosed Study
A study for those newly diagnosed with type 1 diabetes.
About the T1D RELAY study
TrialNet is studying the use of rituximab-pvvrand abatacept, one after the other, to learn if using both treatments extends insulin production in people newly diagnosed with type 1 diabetes (T1D).
Rituximab-pvvr and abatacept have both independently been shown to protect insulin producing beta cells and allow people with newly diagnosed type 1 diabetes to continue producing their own insulin for longer after the diagnosis. T1D RELAY is looking at whether rituximab-pvvr followed by abatacept is more successful at protecting beta cells than rituximab alone.
All participants will receive 4 doses of weekly rituximab-pvvr by intravenous infusion followed by weekly subcutaneous injections of either abatacept OR placebo at a ratio of
2 (abatacept) : 1 (placebo).
Who can participate?
Participants will be required to attend the research centre (Royal Melbourne Hospital, Melbourne) 16 times over a two-year treatment phase followed by a further five visits during the two years follow up phase. All participants will also receive intensive management of their diabetes during the study period.
This study is enrolling people who are:
- Aged 8-45
- Newly diagnosed with T1D (in past 3 months)
- Up to date on recommended vaccines (including COVID-19 and flu)
- Not pregnant, breastfeeding or planning to become pregnant while in the study
Why this study is important?
Any intervention which can stop or delay the progression of clinical disease and preserve functional residual β-cell mass is significant, as it may reduce the burden of living with clinical disease and/or provide protection against hypoglycaemia and provide improved metabolic control resulting in a delay in the micro and macro-vascular complications of diabetes.
This research project has been approved by the Royal Melbourne Hospital:
HREC Reference Number: HREC/57344/MH-2019