This study will enroll 81 people. Half will get the treatment, and half will get a placebo, as the study is double blind. The treatment is a subcutaneous injection once a week. This is the same kind of injection used for insulin itself. Everyone will be followed for two years. The primary data will be C-peptide generation (a marker for natural insulin production), and the secondary data includes A1c, insulin usage, side effects, more C-peptide data, etc.
They started in August 2016 and plan to run until October 2019.
The researchers are planning on recruiting at 30+ different locations throughout the United States. Their clinical trials page says that right now they are only active in Atlanta, Georgia and Lexington, Kentucky. However, I do think they are actively recruiting in Walnut Creek, California as well. (People often forget to update their clinical trial record as they add more sites.) The contact point for enrollment is this email address: JNJ.CT@sylogent.com.
Golimumab is a monoclonal antibody (meaning it very specifically targets one type of cell). In particular, Golimumab targets TNFα (Tumor Necrosis Factor alpha) an immune signalling protein, which triggers several immune responses, including inflammation. This is slightly controversial because researchers such as Dr. Faustman are trying to cure type-1 diabetes by increasing the levels of TNFα, while these researchers are trying to cure type-1 diabetes by decreasing the levels of TNFα. This issue came up in 2009, when Embrel (which lowers TNFα) had a mildly successful Phase-I trial. I discussed the "TNFα: Friend or Foe" at that time:
This study is being done by Janssen Research and Development, which is a large pharmaceutical company.
Clinical Trials Registry: https://clinicaltrials.gov/ct2/show/study/NCT02846545
Drug Web Page: http://www.simponi.com/
Drug Wikipedia Page: https://en.wikipedia.org/wiki/Golimumab
TNF Wikipedia Page: https://en.wikipedia.org/wiki/Tumor_necrosis_factor_alpha
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All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.