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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00279305
Registration number
NCT00279305
Ethics application status
Date submitted
17/01/2006
Date registered
19/01/2006
Date last updated
6/05/2020
Titles & IDs
Public title
Rituximab in New Onset Type 1 Diabetes
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Scientific title
Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset Subjects
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Secondary ID [1]
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U01DK061055
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Secondary ID [2]
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TN05 Ritux
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Universal Trial Number (UTN)
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Trial acronym
TN05
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Anti-CD20 (rituximab)
Treatment: Drugs - Placebo Comparator
Experimental: Rituximab Intravenous Infusion - Participants will receive active rituximab (anti-CD20 monoclonal antibody) as an intravenous infusion, with 4 administrations at weeks 0, 1, 2, and 3 at a dose of 375mg/m2
Placebo Comparator: Placebo Intravenous Infusion - Participants will receive placebo given as an intravenous infusion with 4 administrations at weeks 0, 1, 2, and 3.
Treatment: Drugs: Anti-CD20 (rituximab)
Treatment: Drugs: Placebo Comparator
Placebo intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4-hour Mixed Meal Tolerance Test (MMTT) Administered at 1 Year
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Assessment method [1]
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The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.
The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.
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Timepoint [1]
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When all participants complete the 1 year visit
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Eligibility
Key inclusion criteria
- Between the ages of 8 and 45 years
- Within 3 months of diagnosis of type 1 diabetes
- Have presence of at least one diabetes-related autoantibody
- Must have stimulated C-peptide levels of at least 0.2 pmol/ml measured during a mixed
meal tolerance test (MMTT) within one month of randomization
- If female with reproductive potential, willing to avoid pregnancy and undergo
pregnancy testing while participating in the study
- Have not received an immunization for at least one month
- Must be willing to comply with intensive diabetes management
- Must weigh at least 25 kg at study entry
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Minimum age
8
Years
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Maximum age
45
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Are immunodeficient or have clinically significant chronic lymphopenia
- Have an active infection or positive purified protein derivative (PPD) test result
- Currently pregnant or lactating; or anticipate becoming pregnant.
- Require chronic use of steroids
- Have current or past HIV, hepatitis B, or hepatitis C infection
- Have any complicating medical issues that interfere with study conduct or cause
increased risk
- Have a history of malignancies
- Currently using non-insulin pharmaceuticals that effect glycemic control
- Currently participating in another type 1 diabetes treatment study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2009
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Sample size
Target
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Accrual to date
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Final
87
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Walter and Eliza Hall Institute of Medical Research - Victoria
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Recruitment postcode(s) [1]
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- Victoria
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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Indiana
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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New York
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Canada
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Ontario
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Italy
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State/province [12]
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Milan
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Funding & Sponsors
Primary sponsor type
Government body
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Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Allergy and Infectious Diseases (NIAID)
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Other collaborator category [2]
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Government body
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Name [2]
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Other collaborator category [3]
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Other
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Name [3]
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American Diabetes Association
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Juvenile Diabetes Research Foundation
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Ethics approval
Ethics application status
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Summary
Brief summary
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the
insulin-producing beta cells in the pancreas. Without these beta cells, the body cannot
maintain proper blood glucose levels in response to daily activities such as eating or
exercise. With fewer insulin producing cells blood glucose increases, causing hunger, thirst,
and unexplained weight loss. By the time these symptoms develop, 80-90% of a person's beta
cells have already been destroyed. However, this also means that between 10-20% of these
cells remain that continue to produce insulin.
Scientists have learned that two types of immune cells, B cells and T cells, are involved in
causing type 1 diabetes. T cells are responsible for attacking and destroying the beta cells
that make insulin. Although they don't attack insulin producing cells, B cells may be what
trigger the T cells to attack.
This study will investigate the use of rituximab to see if it can help lower the number of
immune B cells thereby preventing the destruction of any remaining insulin producing beta
cells that remain at diagnosis. Rituximab is approved by the Food and Drug Administration
(FDA) for the treatment of a condition called B-lymphocyte lymphoma. Its effects on the
immune system are well understood through its use in organ transplantation. Research has
shown that rituximab might be helpful in treating other conditions caused by T cells and B
cells, including type 1 diabetes. The goal of this study is to find out if rituximab can
preserve residual insulin secretion and prevent further beta cell destruction in type 1
diabetes.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00279305
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Trial related presentations / publications
Pescovitz MD. The use of rituximab, anti-CD20 monoclonal antibody, in pediatric transplantation. Pediatr Transplant. 2004 Feb;8(1):9-21. doi: 10.1046/j.1397-3142.2003.00135.x.
Noorchashm H, Noorchashm N, Kern J, Rostami SY, Barker CF, Naji A. B-cells are required for the initiation of insulitis and sialitis in nonobese diabetic mice. Diabetes. 1997 Jun;46(6):941-6. doi: 10.2337/diab.46.6.941.
Zecca M, Nobili B, Ramenghi U, Perrotta S, Amendola G, Rosito P, Jankovic M, Pierani P, De Stefano P, Bonora MR, Locatelli F. Rituximab for the treatment of refractory autoimmune hemolytic anemia in children. Blood. 2003 May 15;101(10):3857-61. doi: 10.1182/blood-2002-11-3547. Epub 2003 Jan 16.
Binstadt BA, Caldas AM, Turvey SE, Stone KD, Weinstein HJ, Jackson J, Fuhlbrigge RC, Sundel RP. Rituximab therapy for multisystem autoimmune diseases in pediatric patients. J Pediatr. 2003 Nov;143(5):598-604. doi: 10.1067/s0022-3476(03)00382-2. Erratum In: J Pediatr. 2004 Apr;144(4):558.
Edwards JC, Leandro MJ, Cambridge G. B lymphocyte depletion in rheumatoid arthritis: targeting of CD20. Curr Dir Autoimmun. 2005;8:175-92. doi: 10.1159/000082103.
Sidner RA, Book BK, Agarwal A, Bearden CM, Vieira CA, Pescovitz MD. In vivo human B-cell subset recovery after in vivo depletion with rituximab, anti-human CD20 monoclonal antibody. Hum Antibodies. 2004;13(3):55-62.
Bearden CM, Agarwal A, Book BK, Vieira CA, Sidner RA, Ochs HD, Young M, Pescovitz MD. Rituximab inhibits the in vivo primary and secondary antibody response to a neoantigen, bacteriophage phiX174. Am J Transplant. 2005 Jan;5(1):50-7. doi: 10.1111/j.1600-6143.2003.00646.x.
Edwards JC, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004 Jun 17;350(25):2572-81. doi: 10.1056/NEJMoa032534.
Serreze DV, Silveira PA. The role of B lymphocytes as key antigen-presenting cells in the development of T cell-mediated autoimmune type 1 diabetes. Curr Dir Autoimmun. 2003;6:212-27. doi: 10.1159/000066863. No abstract available.
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Public notes
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Contacts
Principal investigator
Name
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Carla Greenbaum, MD
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Address
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Type 1 Diabetes TrialNet
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00279305
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