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.
As with any research study, there are risks and benefits to participation. Before you decide to participate, a member of your TrialNet research team will explain all potential risks and benefits and answer any questions you may have.
This study is enrolling people who are:
- Age 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
- 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.
The T1D RELAY study will enroll 74 people newly diagnosed with T1D (stage 3). 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.
The study has 2 phases: treatment and follow up.
Treatment (2 years)
Rituximab-pvvr Treatment (4 weeks)
At your first study visit (after your screening visit), you will receive an IV infusion of rituximab-pvvr. You will return to the study site for a rituximab-pvvr infusion once a week for three more weeks. Each infusion will take 3-8 hours.
No treatment for 3 months (12 weeks)
Abatacept Treatment (20 months)
Three months after your last rituximab-pvvr dose, you will be given a supply of syringes filled with abatacept or placebo (looks like the study treatment but is inactive) and taught how to inject it under the skin. You will need to give injections to yourself or your child once per week for 20 months.
Types of tests and monitoring at study visits
We will closely monitor your insulin production, antibodies, overall health and well-being, and diabetes care throughout the study. Participants in the T1D RELAY Study will be expected to wear a continuous glucose monitor (CGM) for 10 days after each study visit, including the initial screening visit. If you don’t have a CGM, we will provide one.
During some study visits, you will have a Mixed Meal Tolerance Test (MMTT) to measure how much insulin your body is making. The MMTT consists of drinking a liquid meal containing proteins, fats and carbohydrates, followed by a blood draw. An intravenous (IV) catheter is used for the blood draw, so there’s only one poke while small samples are collected. There is an MMTT at the screening visit.
Follow up (2 years)
In the study’s follow up phase, you will visit the study site for monitoring every 6 months for 2 years (4 visits minimum). All participants will receive guidance for intensive diabetes management.
Benefits of intensive diabetes management
Studies have shown that keeping blood glucose levels within a healthy range reduces the risk of long-term complications. It might also help any remaining beta cells continue to make some insulin.
How to sign up
You can let us know you’re interested in the T1D RELAY Study by filling out this form. A member of the TrialNet research team will contact you to discuss your eligibility. If this study isn’t right for you, we’ll let you know about other current or upcoming newly diagnosed studies.
If you have questions about this study or TrialNet, please email us: firstname.lastname@example.org.