Clinical Trial

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

Study acronym: TN25
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2019-04-23; most recent amendment 2026-02-17.
Status change: Recruiting → Active, Not Recruiting 2025-05-19
Status change: Suspended → Recruiting 2023-10-30
Status change: Recruiting → Suspended 2021-01-06
Status change: Not Yet Recruiting → Recruiting 2020-02-19
Trial Details
NCT Number NCT03929601
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators: National Institutes of Health (NIH)
Conditions Type 1 Diabetes Mellitus
Enrollment 74 participants
Start Date 2023-10-30
Primary Completion 2027-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-19