This study will evaluate the safety and effectiveness of Zenapax in controlling recurrent eye
inflammations associated with Behcet's disease.
Behcet's disease is usually treated with corticosteroids to suppress inflammation. Other
medicines such as methotrexate, cyclophosphamide, or azathioprine may also be used. These
drugs all can have serious side effects, including liver or kidney damage. Zenapax is a
monoclonal antibody that binds to certain proteins (receptors) on white blood cells,
preventing them from interacting with a chemical called interleukin-2. Blocking this
interaction prevents inflammation.
This study will include 20 patients who had unacceptable side effects from other medicines
used to treat their disease; did not benefit from standard treatment; and refused standard
treatment because of possible side effects of the medicines.
All patients in the study will continue to take their current medicines at the start of the
study. In addition, one group of patients will receive Zenapax and a second group will
receive a placebo. The drug or placebo will be infused into the vein at the start of the
study and every two weeks for the next six weeks, and then every four weeks for the rest of
the study period (24 months). Each infusion lasts about 15 minutes. Patients will have eye
examinations at the time of every treatment, and medicines will be added if needed to control
eye disease. Drugs will be tapered after six months in patients whose eye disease is quiet,
and readjusted as necessary. Neither the doctors nor the patients will know who is receiving
placebo and who is receiving Zenapax until the study ends.
Patients will be given a physical examination, medical history, eye examination, fluorescein
angiography (special photographs of the retina to evaluate the blood vessels in the eye), and
blood tests.
Zenapax was previously studied in 10 patients with uveitis with positive results. The
patients were able to reduce the other medicines they were taking with minimal side effects.