Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
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 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:
- Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected
into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina
are taken using a camera that flashes a blue light into the eye. The pictures show if
any dye has leaked from the vessels into the retina, indicating the presence of
inflammation.
- Optical coherence tomography to measure retinal thickness. The eyes are examined through
a machine that produces cross-sectional pictures of the retina. These measures are
repeated during the study to determine changes, if any, in retinal thickening.
- Stereoscopic color fundus photography to examine the back of the eye. The pupils are
dilated with eye drops to examine and photograph the back of the eye.
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.