Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
|ClinicalTrials.gov Identifier: NCT01280682|
Recruitment Status : Unknown
Verified April 2010 by Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : January 21, 2011
Last Update Posted : January 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: rituximab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immune Intervention With Anti-CD20 Monoclonal Antibody to Preserve Beta Cell Function in Early Onset Type 1 Diabetes|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2013|
anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
- CD19+ cells [ Time Frame: 1 week later ]number of CD19+ cells
- C-peptide level [ Time Frame: 6 monthes later ]C-peptide level during the first 2 hours of a mixed meal tolerance test
- glycated hemoglobin level [ Time Frame: 6 monthes later ]
- insulin dose [ Time Frame: 6 monthes later ]insulin dose(u/Kg)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280682
|Contact: Tao Yang, MD/PhD||86-25-83718836 ext email@example.com|
|First Affiliated Hospital, Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Tao Yang, PhD 86-25-83718836 ext 6466 firstname.lastname@example.org|
|Principal Investigator: Tao Yang, PhD|
|Principal Investigator:||Tao Yang, MD/PhD||First Affiliated Hospital, Nanjing Medical University, China|