Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
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|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280682
|Contact: Tao Yang, MD/PhD||86-25-83718836 ext firstname.lastname@example.org|
|First Affiliated Hospital, Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Tao Yang, PhD 86-25-83718836 ext 6466 email@example.com|
|Principal Investigator: Tao Yang, PhD|
|Principal Investigator:||Tao Yang, MD/PhD||First Affiliated Hospital, Nanjing Medical University, China|