Status:
COMPLETED
Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis
Lead Sponsor:
National Eye Institute (NEI)
Collaborating Sponsors:
The Emmes Company, LLC
Conditions:
Anterior Uveitis
Arthritis, Juvenile Idiopathic
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
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 inflammato...
Detailed Description
Pediatric uveitis represents 5-10 % of all patients with uveitis. Uveitis refers to intraocular inflammatory diseases. The most common type of non-infectious pediatric uveitis, associated with a syste...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participant is from 6 to 18 years of age, inclusive;
- Participant has a diagnosis of non-infectious uveitis associated juvenile idiopathic arthritis (JIA) requiring treatment to control their intraocular inflammatory disease with anti-inflammatory medications, systemic and/or topical at high frequency intervals (greater than or equal to 3 times a day).
- Participant's uveitis is considered active on current regimen
- Participant has uveitis with at least a grade of 1+ for anterior chamber cells in at least one eye
- Participant's uveitis is currently treated or untreated at the time of enrollment
- Participant has visual acuity in at least one eye of 20/640 or better (Early Treatment Diabetic Retinopathy Study (ETDRS) or Electronic Visual Acuity-Amblyopia Treatment Study (EVA-ATS), log minimum angle of resolution (logMAR) less than 1.54).
- 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
- Participant agrees not to undergo elective ocular surgery (e.g., cataract extraction) for the first 6 months of the study.
- Participant has an absolute neutrophil count above 750.
- Participant is not currently pregnant or lactating.
- Participant with reproductive potential and who is sexually active agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment.
- All participants at enrollment has a parent or legal guardian who is able to understand and sign a consent form on their behalf before entering into the study, and participant signs an assent as a minor.
- Meet American College of Rheumatology Criteria for Juvenile Rheumatoid Arthritis (JRA)/JIA (Appendix) but is not newly diagnosed, and has had systemic treatment for their uveitis.
- Be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells.
- Be able to comply with the study requirements.
- Be up to date on all recommended childhood immunizations.
- EXCLUSION CRITERIA:
- Participants under the age of 6 years will not be enrolled in the study due to the reported higher incidence of adverse events related or unrelated to the administration of daclizumab in post-transplant pediatric studies compared to children over age 6.
- Participants who had received previous treatment with an IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of daclizumab.
- Participants with a history or diagnosis of Behcet's disease.
- Participant has a significant active infection.
- Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past 5 years.
- Participant has used latanoprost (Xalatan) within two weeks prior to study enrollment or has a likely need.
- Participant for whom administration of fluorescein dye is medically contraindicated.
- Have a media opacity that precludes assessment of anterior chamber inflammation.
- Be a female who is pregnant or lactating.
- Refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists.
- Have active serious infections or a history of recurring serious infections.
- Evidence of spondyloarthropathy or enthesopathy.
- Have active joint or systemic inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00130637
Start Date
August 1 2005
End Date
May 1 2008
Last Update
January 30 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892