136
Participants
Start Date
March 12, 2015
Primary Completion Date
July 10, 2019
Study Completion Date
August 31, 2020
Tocilizumab (TCZ)
Subjects assigned to this group will receive tocilizumab intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.
Placebo
Subjects assigned to this group will receive placebo intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight \<30kg) every 4 weeks for 24 weeks.
Standard of Care
Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines \[Standard of Care, SOC\])
Lady Cilento Children's Hospital: Department of Endocrinology, South Brisbane
Columbia University, Naomi Berrie Diabetes Center, New York
Children's Hospital of Philadelphia, Philadelphia
University of Florida, Gainesville
University of Miami: Diabetes Research Institute, Miami
University of South Florida: Diabetes Center, Tampa
Vanderbilt University, Nashville
Indiana University Health - Riley Hospital for Children, Indianapolis
University of Iowa, Iowa City
University of Minnesota, Minneapolis
Sanford Research, Sioux Falls
Children's Mercy Hospital, Kansas City
University of Texas Southwestern Medical Center, Dallas
University of California San Francisco, San Francisco
Stanford University, Stanford
Benaroya Research Institute, Seattle
Yale University School of Medicine: Diabetes Endocrinology Research Center, New Haven
Harvard University, Joslin Diabetes Center, Boston
The Children's Hospital at Westmead: Kids Research Institute, Westmead
Collaborators (1)
Immune Tolerance Network (ITN)
NETWORK
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH