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| Sponsor: | National Eye Institute (NEI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00130637 |
Purpose
This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines.
Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study.
Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests:
Upon entering the study, participants receive a 90-minute infusion of daclizumab through a catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four weeks after the third infusion, patients are examined for response to treatment. Those who have benefited from daclizumab may continue receiving monthly infusions of the drug for up to one year. A blood test and eye examination are done at the time of each infusion. Patients whose disease has remained active 12 weeks after the first infusion are taken off the study and treated with other medications.
| Condition | Intervention | Phase |
|---|---|---|
|
Anterior Uveitis Arthritis, Juvenile Idiopathic Iritis Immunosuppression |
Drug: Daclizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Active Anterior Uveitis Associated With JIA, Using Humanized Anti-Tac (HAT, Daclizumab) |
| Enrollment: | 6 |
| Study Start Date: | August 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Daclizumab |
Drug: Daclizumab
Other Name: Human Anti-Tac
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 6 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Participant has normal renal or liver function or evidence of no worse than mild abnormalities as defined by the "Common Toxicity Criteria for Adverse Events" (CTCAE) version 3.0, including:
Test Parameter Age (yrs) Pediatric Mild Limit
Serum creatinine 6-12 1.0 mg/dL
13-18 1.6 mg/dL
Proteinuria 6-18 3 g/L
Uric acid 6-18 9.9 mg/dL
Blood Urea Nitrogen (BUN) 6-18 2.0 upper normal limit
Aspartate aminotransferase (Serum glutamic-oxaloacetic transaminase) (AST (SGOT)) 6-18 2.5 upper normal limit
Alanine aminotransferase (Serum glutamic pyruvic transaminase) (ALT (SGPT)) 6-18 2.5 upper normal limit
EXCLUSION CRITERIA:
Contacts and Locations
More Information
| 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 |
|
Anterior Uveitis Arthritis, Juvenile Idiopathic Daclizumab Iritis |
Immunosuppression Chronic Inflammatory Eye-Disease Juvenile Idiopathic Arthritis |
|
Arthritis Iritis Uveitis Uveitis, Anterior Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Iris Diseases Uveal Diseases Eye Diseases Panuveitis |
Arthritis, Rheumatoid Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Daclizumab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |