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NCT Number: NCT01280682

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

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Affiliated Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of type 1 diabetes
  • The age of subjects between 8 and 70 years old
  • Course of disease within 12 months
  • 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)]
  • Fasting 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

Treatment and study plan

Rituximab

Drug

anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)

Other names: anti-CD20 monoclonal antibody

Primary outcomes

  1. Change of 3-hour Mean Area Under the Curve (AUC) of C-peptide

    Time frame: 6 months after participants completed the injection

    Change of 3-hour mean area under the curve (AUC) of C-peptide at 6 months from baseline. AUC was calculated from C-peptide timing measurements during the 3-hour mixed meal tolerance test with the trapezoidal rule. The mean AUC for C-peptide is equal to the calculated AUC divided by the 3 h interval (i.e., AUC/180). All mean C-peptide AUC data were transformed as log (mean AUC) for analysis.

Secondary outcomes

  1. Change of Fasting C-peptide

    Time frame: 6 months after participants completed the injection

    The change of fasting level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All fasting C-peptide data were transformed as log (fasting C-peptide) for analysis.

  2. Change of Peak C-peptide

    Time frame: 6 months after participants completed the injection

    The change of peak level of C-peptide during the 3-hour of a mixed meal tolerance test at 6 months from baseline. All peak C-peptide data were transformed as log (peak C-peptide) for analysis.

  3. HbA1c Levels

    Time frame: 6 months after participants completed the injection

    Glycated hemoglobin (HbA1c) levels (%)

Sponsors and collaborators

Lead sponsor

Yang Tao

Other

Registry information

Official study title

Immune Intervention With Anti-CD20 Monoclonal Antibody to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

Important dates

Study start
2010
Primary completion
2016
Study completion
2018
First posted
Jan 21, 2011
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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