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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Outcome Measures

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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)

Eligibility Criteria

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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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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