https://clinicaltrials.gov/ct2/show/NCT03929601
Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes (TN25)
Study Type : Interventional
Estimated Enrollment : 36 participants
Intervention Model: Sequential Assignment
Intervention Model Description: The arm for this study is experimental. It consists of a rituximab dose followed by an abatacept dose. Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart, starting at Week 1 of the study. Abatacept will be given by a subcutaneous formulation weekly for 2 years, beginning at Week 16 (Month 4) of the study. Dosing will be determined by 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).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rituximab and Abatacept for Prevention or Reversal of Type 1 Diabetes
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026
