Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Recruitment status was: Recruiting
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus, Type 1 | Drug: rituximab | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
- CD19+ cells [ Time Frame: 1 week later ]number of CD19+ cells
- C-peptide level [ Time Frame: 6 monthes later ]C-peptide level during the first 2 hours of a mixed meal tolerance test
- glycated hemoglobin level [ Time Frame: 6 monthes later ]
- insulin dose [ Time Frame: 6 monthes later ]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
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| Ages Eligible for Study: | 8 Years to 45 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280682
| Contact: Tao Yang, MD/PhD | 86-25-83718836 ext 6466 | yangt@njmu.edu.cn |
| 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 | |
| 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 |
| First Submitted: | July 29, 2010 |
| First Posted: | January 21, 2011 |
| Last Update Posted: | October 12, 2017 |
| 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 |