NCT01280682

Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

Immune Intervention With Anti-CD20 Monoclonal Antibody to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Yang Tao · Academic / Other
• Sex: All
• Age: 8 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Detailed description

Although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of beta-cell destruction in type 1 diabetes is typically associated with T-lymphocyte autoimmunity. Many T-lymphocyte-mediated diseases include a B-lymphocyte component. B lymphocytes can play a crucial role as antigen-presenting cells, expressing high levels of class II major-histocompatibility-complex antigens and generating cryptic peptides to which T lymphocytes are not tolerant. B lymphocytes can be selectively depleted with the anti-CD20 monoclonal antibody. We will test the hypothesis that transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	rituximab	anti-CD20 monoclonal antibody 125mg/m\^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Timeline

• Start date: 2010-07-01
• Primary completion: 2016-12-01
• Completion: 2018-12-01
• First posted: 2011-01-21
• Last updated: 2023-12-11
• Results posted: 2023-12-11

Locations

1 site across 1 country: China