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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130637
First Posted: August 15, 2005
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The EMMES Corporation
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
Results First Submitted: August 12, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      6 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 10.2  (4.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  66.7% 
Male      2  33.3% 
Region of Enrollment 
[Units: Participants]
 
United States   6 


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

2.  Primary:   Number of Participants Reporting a Serious Adverse Event (SAE)   [ Time Frame: 52 weeks ]


  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 of Results:
Other Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
ClinicalTrials.gov Identifier: NCT00130637     History of Changes
Other Study ID Numbers: 050208
05-EI-0208
First Submitted: August 12, 2005
First Posted: August 15, 2005
Results First Submitted: August 12, 2010
Results First Posted: September 29, 2010
Last Update Posted: January 30, 2017