Carla Greenbaum, MD | Benaroya Research Institute | Seattle, WA
Jane Buckner, MD | Benaroya Research Institute | Seattle, WA
Stanford University | Stanford, CA
University of California San Francisco | San Francisco, CA
Yale University | New Haven, CT
University of Florida | Gainsville, FL
University of Miami | Miami, FL
University of South Florida | Tampa, FL
Indiana University, Riley Hospital for Children | Indianapolis, IN
University of Iowa | Iowa City, IA
Joslin Diabetes Center | Boston, MA
University of Minnesota | Minneapolis, MN
Children's Mercy Hospital | Kansas City, MO
Columbia University, Naomi Berrie Diabetes Center | New York, NY
Children's Hospital of Philadelphia | Philadelphia, PA
Sanford Research | Sioux Falls, SD
Vanderbilt University | Nashville, TN
UT Southwestern Medical Center | Dallas, TX
Benaroya Research Institute | Seattle, WA
Children's Hospital at Weastmead | Westmead, NSW, Australia
Queensland Children's Hospital | South Brisbane, QLD, Australia
ITN058AI
Completed
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.
Greenbaum CJ, Serti E, Lambert K, Weiner LJ, Kanaparthi S, Lord S, Gitelman SE, Wilson DM, Gaglia JL, Griffin KJ, Russell WE, Raskin P, Moran A, Steven M. Willi, Tsalikian E, DiMeglio LA, Herold KC, Moore WV, Goland R, Harris M, Craig ME, Schatz DA, Baidal DA, Rodriguez H, Utzschneider KM, Nel HJ, Soppe CL, Boyle KD, Cerosaletti K, Keyes-Elstein L, Long SA, Thomas R, McNamara JG, Buckner JH, Sanda S, ITN058AI EXTEND Study Team (2021). IL-6 receptor blockade does not slow β cell loss in new-onset type 1 diabetes. JCI Insight, 6 (21), e150074.
DOI:
http://dx.doi.org/10.1172/jci.insight.150074,
PMID:
34747368
,
PMCID:
PMC8663550
,
PubMed,
Reprint
