Study Name: Immune effects of vedolizumab with or without anti-TNF pre-treatment in T1D
Principal Investigator: Sandra Lord, MD
What is the COBRA Study?
We are testing whether the study drug vedolizumab is safe and potentially effective in adults with type 1 diabetes (T1D), on its own or when following pre-treatment with etanercept.
We are testing this combination because we think that these two drugs may have complementary actions on the immune system and thus can work together to preserve insulin production.
Vedolizumab is FDA-approved for the treatment of Crohn’s Disease and Ulcerative Colitis, which are autoimmune diseases like type 1 diabetes. Vedolizumab works by blocking migration of certain immune cells to tissues in the gastrointestinal tract, including the pancreas.
Etanercept is FDA-approved for the treatment of certain types of autoimmune arthritis. It works by blocking some of the inflammatory chemicals that are involved in autoimmunity. Etanercept has been shown in earlier studies to help preserve insulin secretion.
Who can participate?
You may be eligible to participate if you:
- Are 18-45 years old
- Were diagnosed with T1D in the last 3 years
- Are fully vaccinated for COVID-19 and influenza
- Are in good general health
- Live in or near Seattle
What will study participants be asked to do?
First, a researcher will have a phone conversation with you to review initial screening criteria. If you meet initial criteria, you’ll be invited to Benaroya Research Institute’s clinical research center at Virginia Mason Hospital for a screening visit.
If you qualify, you will be randomly assigned to one of two study arms, Arm A or Arm B.
During the dosing phase, those assigned to Arm A will have eight study visits over 26 weeks receiving etanercept followed by vedolizumab, while those assigned to Arm B will have six study visits over 20 weeks and receive vedolizumab only.
During the follow-up phase, all participants will have one additional visit at 52 weeks.
If you’d like to participate, please call us at 800-888-4187 or email Diabetes@BenaroyaResearch.org.