74
Participants
Start Date
October 30, 2023
Primary Completion Date
March 31, 2027
Study Completion Date
March 31, 2029
Rituximab-pvvr
All participants will receive Rituximab-pvvr dosing from Week 1 to Week 4 of the trial. Rituximab-pvvr will be given by IV infusion over at least 3 hours, at a dose of 375mg/m2 on four visits each one week apart.
Abatacept
Participants in the active drug arm will receive initial Abatacept dosing at Week 16 of trial. Abatacept will be given by a subcutaneous (SC) formulation weekly for 20 months, and dosing be will determined according to weight: Up to 25 kg: 50 mg (0.4 mL); 25 to \<50 kg receive 87.5 mg (0.7 mL), and \> 50 kg receive 125 mg (1.0 mL).
Sterile Sodium Chloride
Participants in the placebo arm will receive initial placebo injection at Week 16 of trial. Saline Placebo will be given by a subcutaneous (SC) formulation weekly for 20 months, and dosing volume be will determined according to weight to match active comparator: Up to 25 kg: 0.4 mL; 25 to \<50 kg receive 0.7 mL and \> 50 kg receive 1.0 mL.
Walter and Eliza Hall Institute of Medical Research, Melbourne
Queensland Children's Hospital, South Brisbane
Columbia University, New York
University of Pittsburg, Pittsburgh
University of Florida, Gainesville
University of Miami, Maimi
Vanderbilt Eskind Diabetes Center, Nashville
Indiana University - Riley Hospital for Children, Indianapolis
University of Minnesota, Minneapolis
Sanford Children's Specialty Clinic, Sioux Falls
The Children's Mercy Hospital, Kansas City
University of Texas Southwestern, Dallas
Barbara Davis Center for Childhood Diabetes, Aurora
Childrens Hospital of Orange County, Orange
University of California San Francisco, San Francisco
Stanford University, Palo Alto
Benaroya Research Institute, Seattle
Yale University, New Haven
Joslin Diabetes Center, Boston
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH