Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Rituximab in New Onset Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
American Diabetes Association
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00279305
First received: January 17, 2006
Last updated: September 27, 2016
Last verified: September 2016
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Interventions: Drug: Anti-CD20 (rituximab)
Drug: Placebo Comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with newly diagnosed type 1 diabetes recruited from 12 TrialNet Clinical Centers between

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
126 patients were assessed; 39 were excluded; 87 underwent randomization (57 were assigned to receive rituximab and 30 were assigned to receive placebo)

Reporting Groups
  Description
Rituximab Treatment Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
Placebo Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.

Participant Flow:   Overall Study
    Rituximab Treatment   Placebo
STARTED   57   30 
COMPLETED   49   29 
NOT COMPLETED   8   1 
Pregnancy                1                0 
Withdrawal by Subject                2                0 
Dificulting establishing IV                1                0 
FDA Safety Alert                4                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Rituximab Treatment Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
Placebo Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
Total Total of all reporting groups

Baseline Measures
   Rituximab Treatment   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   30   87 
Age 
[Units: Years]
Mean (Standard Deviation)
 19.0  (8.6)   17.4  (8.0)   18.5  (8.3) 
Gender 
[Units: Participants]
     
Female   21   12   33 
Male   36   18   54 


  Outcome Measures

1.  Primary:   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   [ Time Frame: When all participants complete the 1 year visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carla Greenbaum, MD
Organization: Type 1 Diabetes TrialNet
e-mail: cjgreen@benaroyaresearch.org


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00279305     History of Changes
Other Study ID Numbers: Ritux (IND) (completed)
Study First Received: January 17, 2006
Results First Received: May 12, 2016
Last Updated: September 27, 2016
Health Authority: United States: Food and Drug Administration