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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Nanjing Medical University.
Recruitment status was:  Recruiting
Information provided by:
Nanjing Medical University Identifier:
First received: July 29, 2010
Last updated: January 19, 2011
Last verified: April 2010
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.

Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: rituximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • CD19+ cells [ Time Frame: 1 week later ]
    number of CD19+ cells

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 50
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)
Arms Assigned Interventions
Experimental: rituximab Drug: rituximab
anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

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.


Ages Eligible for Study:   8 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of type 1 diabetes
  • The age of subjects between 8 and 45 years old
  • Course of disease within 1 year
  • Presence of at least one type of detectable islet autoantibody [zinc transporter 8 antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)]
  • Stimulated peak C-peptide levels of at least 0.2 pmol/mL

Exclusion Criteria:

  • Confirmed diagnosis of type 2 diabetes
  • Severe chronic or acute complications of diabetes
  • Severe infection or damage to the immune response
  • Presence of chronic latent infection in vivo
  • Viral hepatitis B patients whose hepatitis B virus(HBV)DNA > log10^5
  • Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate aminotransferase(AST), and creatinine more than 2 times the upper limit of normal
  • Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤ 60mmHg
  • Patients with rheumatoid arthritis
  • Allergic to any component of this drug
  • Pregnancy, breast-feeding women
  • Use of other immunosuppressive agents 3 months before selected
  Contacts and Locations
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Please refer to this study by its identifier: NCT01280682

Contact: Tao Yang, MD/PhD 86-25-83718836 ext 6466

China, Jiangsu
First Affiliated Hospital, Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Tao Yang, PhD    86-25-83718836 ext 6466   
Principal Investigator: Tao Yang, PhD         
Sponsors and Collaborators
Nanjing Medical University
Principal Investigator: Tao Yang, MD/PhD First Affiliated Hospital, Nanjing Medical University, China
  More Information

Responsible Party: Department of Endocrinology & Metabolism Identifier: NCT01280682     History of Changes
Other Study ID Numbers: 2010-SR-021
Study First Received: July 29, 2010
Last Updated: January 19, 2011

Keywords provided by Nanjing Medical University:
type 1 diabetes
course of disease
C-peptide levels

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 23, 2017