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Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00130637
First received: August 12, 2005
Last updated: November 24, 2010
Last verified: November 2010
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anterior Uveitis
Arthritis, Juvenile Idiopathic
Iritis
Immunosuppression
Intervention: Drug: Daclizumab

  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
single center, 6 participants

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
pilot, non-randomized, open-label trial

Reporting Groups
  Description
Daclizumab An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.

Participant Flow:   Overall Study
    Daclizumab  
STARTED     6  
COMPLETED     3  
NOT COMPLETED     3  
Adverse Event                 2  
Withdrawal by Subject                 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.
No text entered.

Reporting Groups
  Description
Daclizumab An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.

Baseline Measures
    Daclizumab  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     6  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.2  ± 4.8  
Gender  
[units: participants]
 
Female     4  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures

1.  Primary:   Number of Participants With a Two-step Reduction in Inflammation   [ Time Frame: 12 weeks ]

2.  Primary:   Number of Participants Reporting an Adverse Event   [ Time Frame: 52 weeks ]
Results not yet reported.   Anticipated Reporting Date:   11/2010   Safety Issue:   Yes


  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
The results of this trial need to be interpreted cautiously because of the small number of patients, the heterogeneity of the patient population (such as one participant with systemic JIA), and the nonrandomized and unmasked nature of the trial.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: H. Nida Sen, MD, MHS
Organization: National Eye Institute, NIH
phone: 301-435-5139
e-mail: senh@nei.nih.gov


Publications:
Publications automatically indexed to this study:

Responsible Party: Robert Nussenblatt, M.D./National Eye Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00130637     History of Changes
Other Study ID Numbers: 050208, 05-EI-0208
Study First Received: August 12, 2005
Results First Received: August 12, 2010
Last Updated: November 24, 2010
Health Authority: United States: Food and Drug Administration