T1D RELAY – Rituximab-pvvr and Abatacept Newly Diagnosed Study

The medicines Rituximab-pvvr and abatacept have both been shown to protect insulin-producing beta cells from immune attack, allowing people with newly diagnosed type 1 diabetes (T1D) to continue producing their own insulin for longer. This trial will look at whether combining these two medicines is better at protecting beta cells from immune attack than rituximab-pvvr alone.

Who can get involved

• Aged between 8 and 45 years.
• Evidence of insulin production, determined by one or more diabetes-related antibodies and detectable C-peptide during a mixed-meal tolerance test (MMTT).
• Up to date with immunisation schedule, including COVID-19 and flu boosters.

Treatment

Participants in this study will receive weekly rituximab-pvvr by intravenous infusion (into a vein in the arm) for four weeks. Participants will then receive weekly injections of abatacept OR placebo (inactive equivalent). Two in every three participants will receive active treatment (abatacept), while one in three will receive placebo. The allocation of medication will be done randomly.

Study visits

Participants will be required to attend 16 visits at a participating clinical centre over a two-year treatment period and a further five visits over a two year follow up period after the treatment. The first four visits for the rituximab-pvvr infusion will take up to eight hours. The remaining visits will vary in duration from one to four hours.

Benefits of participation

All participants in this study will receive active treatment in the form of rituximab-pvvr. Two in every three participants will then receive a second active treatment called abatacept. In addition to the potential for these study medications to delay the progression of T1D, participants will be closely monitored and blood glucose levels managed intensively. This may reduce the risk of long-term complications of T1D, as well as helping remaining beta cells in the pancreas to continue making insulin on their own.

This trial is being undertaken by the JDRF-funded Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC).

To find out if you are eligible or if you have any questions contact the ATIC team.