Status:
COMPLETED
Rituximab in New Onset Type 1 Diabetes
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-45 years
Phase:
PHASE2
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...
Detailed Description
The study is a randomized, two-arm, trial in which 2/3 of participants will receive the study drug, while the remaining 1/3 will receive a placebo (a pretend medicine that does nothing). The group you...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00279305
Start Date
August 1 2005
End Date
November 1 2009
Last Update
May 6 2020
Active Locations (16)
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1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California-San Francisco
San Francisco, California, United States, 94143
3
Stanford University
Stanford, California, United States, 94305
4
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80010