Welcome to the REBOOT Study
The REBOOT study will test whether a combination of two different drugs, belimumab (Benlysta®) and rituximab (Rituxan®), is safe and if this combination is more effective at blocking the immune attack on the kidney in patients with Primary Membranous Neuropathy (MN) compared to rituximab alone.
About the Investigational Study Drug
Rituximab is a medication that works by blocking B cells (an immune cell that is known to have a role in autoimmune diseases like Primary MN). Rituximab is approved by the FDA for use in rheumatoid arthritis, vasculitis, and certain types of cancers. A few studies have shown that rituximab can be effective in treating some people with Primary MN, but is not FDA approved for Primary MN.
Belimumab is a medication that blocks different types of B cells than rituximab. Belimumab is approved by the FDA for systemic lupus erythematosus (SLE).
REBOOT will investigate whether belimumab, when combined with rituximab, will help remove more B cells than rituximab alone, which may help treat Primary MN. The study will also look at whether belimumab treatment will change the type of B cells that re-grow after treatment with rituximab, which may help Primary MN from coming back.
The combination of belimumab and rituximab is considered experimental for Primary MN.
REBOOT Part A
People with Primary MN lose more protein in their urine because the filters in their kidneys may be damaged. It is possible that some belimumab may also be lost in the urine because of this. To make up for this loss, people with higher levels of protein in their urine may need a higher dose of belimumab than the FDA approved dose. One purpose of Part A was to measure belimumab in the blood to determine if people with more protein in their urine should receive a higher dose of belimumab. Part A is closed to enrollment.
REBOOT Part B
Part B participants will be randomly assigned to 1 of 2 treatment groups. One group will receive weekly subcutaneous belimumab (self-injections under the skin) for 1 year. The other group will receive weekly subcutaneous belimumab placebo (an inactive substance that looks like the drug) for 1 year. All participants will receive intravenous (IV) rituximab at weeks 4 and 6. Participants will also receive IV rituximab at weeks 34 and 36 if criteria are met. Participants will be followed for an additional 2 years to determine if Primary MN gets better or worse after stopping study treatment.
You cannot choose your treatment group. A computer will randomly pick which group you will be in. For every four participants, three will be assigned to group 1 and one will be assigned to group 2. This study is double-blinded which means that during the study neither you nor your study doctor will know whether you are receiving belimumab or belimumab placebo.
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Treatment Phase |
Follow-up Phase |
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Part B Group 1 |
Belimumab weeks 0-51 |
Follow for safety and Primary MN status |
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Part B Group 2 |
Belimumab placebo weeks 0-51 |
Follow for safety and Primary MN status |