Summary

Eligibility
for people ages 8-45 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.

Details

This is a two-arm, double-blind, multicenter clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in individuals with new onset T1D to determine whether rituximab-pvvr followed by abatacept results in an improvement in the AUC C-Peptide during a MMTT compared to Rituximab-pvvr alone at 24 months. Additional aims will compare the safety, tolerability in the two treatment arms as well as other clinical metabolic measures: exogenous insulin use, hemoglobin A1c, time in range from continuous glucose monitors, and severe hypoglycemia. Exploratory studies will assess changes in immune markers.

Keywords

Type 1 Diabetes Mellitus, Diabetes Mellitus, Rituximab, Abatacept, Rituximab-pvvr, Sterile Sodium Chloride, Rituximab-pvvr followed by Abatacept

Eligibility

Locations

  • UCSF
    San Francisco California 94158 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Links
Study Sponsor Website
ID
NCT03929601
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 74 people participating
Last Updated