Text Size

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

This study is currently recruiting participants.
Verified April 2010 by Nanjing Medical University
Sponsor:
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01280682
First received: July 29, 2010
Last updated: January 19, 2011
Last verified: April 2010
History of Changes
  Purpose

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
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

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • CD19+ cells [ Time Frame: 1 week later ] [ Designated as safety issue: Yes ]
    number of CD19+ cells


Secondary Outcome Measures:
  • 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)


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)
Other Name: rituximab

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.

  Eligibility

Ages Eligible for Study:   8 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Department of Endocrinology & Metabolism
ClinicalTrials.gov Identifier: NCT01280682     History of Changes
Other Study ID Numbers: 2010-SR-021
Study First Received: July 29, 2010
Last Updated: January 19, 2011
Health Authority: China: Ethics Committee

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
Antibodies, Monoclonal
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 22, 2013