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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
Sponsor:
Information provided by:
Nanjing Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: rituximab Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: rituximab Drug: rituximab
anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)




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


Secondary Outcome Measures :
  1. C-peptide level [ Time Frame: 6 monthes later ]
    C-peptide level during the first 2 hours of a mixed meal tolerance test

  2. glycated hemoglobin level [ Time Frame: 6 monthes later ]
  3. insulin dose [ Time Frame: 6 monthes later ]
    insulin dose(u/Kg)



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

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

Information from the National Library of Medicine

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


Contacts
Contact: Tao Yang, MD/PhD 86-25-83718836 ext 6466 yangt@njmu.edu.cn

Locations
China, Jiangsu
First Affiliated Hospital, Nanjing Medical University Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Tao Yang, PhD    86-25-83718836 ext 6466    yangt@njmu.edu.cn   
Principal Investigator: Tao Yang, PhD         
Sponsors and Collaborators
Nanjing Medical University
Investigators
Principal Investigator: Tao Yang, MD/PhD First Affiliated Hospital, Nanjing Medical University, China

Responsible Party: Department of Endocrinology & Metabolism
ClinicalTrials.gov Identifier: NCT01280682     History of Changes
Other Study ID Numbers: 2010-SR-021
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: April 2010

Keywords provided by Nanjing Medical University:
type 1 diabetes
age
course of disease
autoantibodies
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
Rituximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents