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

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

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.

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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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.

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 ]

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2. Primary:

Number of Participants Reporting an Adverse Event [ Time Frame: 52 weeks ]

Results not yet posted. Anticipated Posting Date: 11/2010 Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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.

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:

Chylack LT Jr. The ocular manifestations of juvenile rheumatoid arthritis. Arthritis Rheum. 1977 Mar;20(2 Suppl):217-23.

Publications automatically indexed to this study:

Sen HN, Levy-Clarke G, Faia LJ, Li Z, Yeh S, Barron KS, Ryan JG, Hammel K, Nussenblatt RB. High-dose daclizumab for the treatment of juvenile idiopathic arthritis-associated active anterior uveitis. Am J Ophthalmol. 2009 Nov;148(5):696-703.e1. Epub 2009 Aug 6.

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