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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by Nanjing Medical University.
Recruitment status was Recruiting

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

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)

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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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, Type 1 Diabetes Mellitus 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

ClinicalTrials.gov processed this record on September 27, 2016

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