Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes (the EXTEND Study)

  • STATUS
    Recruiting
  • sponsor
    NIAID
Updated on 23 November 2020

Summary

Preserving Beta-Cell Function with Tocilizumab in New Onset Type 1 Diabetes (the EXTEND Study)

Description

The healthy insulin-producing beta cells that you have left when you are first diagnosed with type 1 diabetes are precious. The aim of the EXTEND Study is to test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking these remaining beta cells and possibly extend the ability to naturally produce insulin. Currently there are no approved treatments that are able to do this.

Participants in the EXTEND study will be randomly assigned to one of two groups. One group will be given the study drug, tocilizumab, and the other group will receive an inactive substance made to look like the study drug, called a placebo.

Tocilizumab or placebo will be given once every 4 weeks over a 24 week period. There will be a total of 7 intravenous infusions with four additional follow-up visits during the next 18 months. Total study time is 2 years.

For more information, visit www.extend-study.org

Details
Clinical Study IdentifierTX140078
SponsorNIAID
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

You may be eligible to participate in the EXTEND Study if you
Are male or female, aged 18-45
Have been diagnosed with type 1 diabetes within the last 3 months
Are in good general health
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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