Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Recruitment status was: Recruiting
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Immune Intervention With Anti-CD20 Monoclonal Antibody to Preserve Beta Cell Function in Early Onset Type 1 Diabetes|
- CD19+ cells [ Time Frame: 1 week later ] [ Designated as safety issue: Yes ]number of CD19+ cells
- C-peptide level [ Time Frame: 6 monthes later ] [ Designated as safety issue: Yes ]C-peptide level during the first 2 hours of a mixed meal tolerance test
- glycated hemoglobin level [ Time Frame: 6 monthes later ] [ Designated as safety issue: Yes ]
- insulin dose [ Time Frame: 6 monthes later ] [ Designated as safety issue: Yes ]insulin dose(u/Kg)
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280682
|First Affiliated Hospital, Nanjing Medical University|
|Nanjing, Jiangsu, China, 210029|
|Principal Investigator:||Tao Yang, MD/PhD||First Affiliated Hospital, Nanjing Medical University, China|