Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease

Inclusion Criteria

• Is a male or a non-pregnant, non-lactating female.
• Has a history and clinical presentation consistent with a diagnosis of Behçet's Disease and meets International Study Group criteria (Appendix B).
• Has a history of oral ulcers for at least 12 months.
• Has a history of monthly episodes of multiple oral ulcers.
• Has the presence of at least 2 oral ulcers at study entry, both of which are accessible to measurement, with a total diameter of at least 4 mm.
• Has signed an IRB approved subject consent form.
• Has completed all screening procedures satisfactorily, is deemed to be an acceptable subject and is otherwise eligible for entry into the study.
• Is willing and able to comply with the protocol.

Exclusion Criteria

• Has a severe, acute, or chronic systemic disease other than Behçet's Disease such as congestive heart failure, hepatic failure, renal failure, Systemic Lupus Erythematosus (SLE), Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS or ARC, or any other condition for which they are immunocompromised.
• Is under active treatment for dental conditions, such that multiple dental office visits would be required during the study period, or presents with oral conditions which are not thought to be related to Behçet's Disease and, in the judgment of a qualified dentist, will require treatment during the study period.
• Is suffering from any medical condition other than Behçet's Disease known to cause oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid, SLE, Crohn's disease, Reiter's syndrome, or AIDS.
• Has an eating disorder and/or psychiatric illness requiring treatment.
• Has hypersensitivity to interferon-alpha.
• Is a pregnant or lactating female, or is of childbearing potential and is not using a medically acceptable contraceptive method throughout the study.
• Has had previous exposure to any parenteral interferon therapy.
• Has had exposure to IFNα lozenges within 30 days of screening.
• Has had exposure to thalidomide within 30 days of screening.
• Has had exposure to methotrexate within 30 days of screening.
• Has had exposure to any immune-suppressive medication within 30 days of screening.
• Has a history of, or is currently exhibiting, any disease or condition which, in the opinion of the Principal Investigator, would place the subject at increased risk during study therapy.
• Has any abnormality in a hematological or biochemical variable which, in the opinion of the Principal Investigator, would place the subject at increased risk during study therapy.