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Abstract
EXTEND is a clinical research study that will test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking the remaining beta cells and possibly extend the ability to naturally produce insulin in individuals recently diagnosed with type 1 diabetes. Currently there are no approved treatments that are able to do this.
Tocilizumab is a medication which subdues the immune system by targeting the receptor for a molecule called IL-6. IL-6 is thought to be involved in type 1 diabetes and may be contributing to inflammation that can lead to destruction of beta cells.
Tocilizumab has already been approved by the FDA for use in treating adults with rheumatoid arthritis and for treating young children with juvenile idoiopathic arthritis (JIA). However, tocilizumab has never been tested in patients with type 1 diabetes and, therefore, is considered an experimental treatment in this study.
EXTEND is a randomized double-blind clinical trial in which two-thirds of the participants will recieve tocilizumab and one third will recieve placebo. During the 6-month treatment period, participants will recieve tocilizumab or placebo by IV once every 4 weeks. There will be four follow-up visits during the 18-month follow up period.
About This Study
EXTEND is a clinical research study that will test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking the remaining beta cells and possibly extend the ability to naturally produce insulin in individuals recently diagnosed with type 1 diabetes. Currently there are no approved treatments that are able to do this.
Tocilizumab is a medication which subdues the immune system by targeting the receptor for a molecule called IL-6. IL-6 is thought to be involved in type 1 diabetes and may be contributing to inflammation that can lead to destruction of beta cells.
Tocilizumab has already been approved by the FDA for use in treating adults with rheumatoid arthritis and for treating young children with juvenile idoiopathic arthritis (JIA). However, tocilizumab has never been tested in patients with type 1 diabetes and, therefore, is considered an experimental treatment in this study.
EXTEND is a randomized double-blind clinical trial in which two-thirds of the participants will recieve tocilizumab and one third will recieve placebo. During the 6-month treatment period, participants will recieve tocilizumab or placebo by IV once every 4 weeks. There will be four follow-up visits during the 18-month follow up period.