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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

rituximab

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring type 1 diabetes, age, course of disease, autoantibodies, C-peptide levels

Eligibility Criteria

8 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

First Affiliated Hospital, Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rituximab

Arm Description

Outcomes

Primary Outcome Measures

CD19+ cells

number of CD19+ cells

Secondary Outcome Measures

C-peptide level

C-peptide level during the first 2 hours of a mixed meal tolerance test

glycated hemoglobin level

insulin dose

insulin dose(u/Kg)

Full Information

NCT ID

NCT01280682

First Posted

July 29, 2010

Last Updated

January 19, 2011

Sponsor

Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01280682

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes, age, course of disease, autoantibodies, C-peptide levels

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rituximab

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

rituximab

Intervention Description

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

Primary Outcome Measure Information:

Title

CD19+ cells

Description

number of CD19+ cells

Time Frame

1 week later

Secondary Outcome Measure Information:

Title

C-peptide level

Description

C-peptide level during the first 2 hours of a mixed meal tolerance test

Time Frame

6 monthes later

Title

glycated hemoglobin level

Time Frame

6 monthes later

Title

insulin dose

Description

insulin dose(u/Kg)

Time Frame

6 monthes later

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Yang, MD/PhD

Phone

86-25-83718836

Ext

6466

yangt@njmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Yang, MD/PhD

Organizational Affiliation

First Affiliated Hospital, Nanjing Medical University, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital, Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Yang, PhD

Phone

86-25-83718836

Ext

6466

yangt@njmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Tao Yang, PhD

12. IPD Sharing Statement

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

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