Efficacy of Humira in Behcet Patients With Arthritis

Study Design (including visit schedule, dosing and procedures/methods):

Screen visit, 1st visit -treatment initiation, follow-up visits - after 1 month and afterwards every 8 weeks for 24 weeks.

Screen visit: informed consent, medical history,inclusion and exclusion criteria, pregnancy test, vital signs, physical examination, joint evaluation (no. of tender joints, no. of swollen joints), patient/investigator global disease activity, pain VAS, HAQ, Behcet Disease Current Activity Forms (BDACF), ECG, PPD and chest X-ray screening for tuberculosis, routine labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, HbsAg and AntiHCV, immunology labs (rheumatoid factor, anti-CCP, anti nuclear antibody - ANA).

An induration of greater than 5 mm will be considered a positive PPD reaction.

Follow up visits .: Vital signs, joint evaluation, patient/investigator global disease activity, pain VAS, HAQ, BDACF, routine labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, research blood samples for storage.

Inclusion criteria

• Able and willing to give written informed consent and comply with the requirements of the study protocol.
• Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease.
• Experienced an inadequate response to previous or current treatment with one or more DMARDs because of inadequate efficacy or side effects.
• DMARDS and/or corticosteroids (< or equivalent to 10mg/d prednisone) permitted if stable for at least 4 weeks prior to screening. NSAIDs permitted if stable for at least 2 weeks prior to screening.
• Active peripheral arthritis at screening (tenderness and swelling of at least 3 small joints or one large joint) OR axial involvement (active enthesitis or spondylitis)
• Age 18-80 years.
• If female and of childbearing potential, a negative urine pregnancy test within 2 weeks prior to therapy, and using reliable means of contraception.

Exclusion criteria

• Rheumatic autoimmune disease other than Behcet (Rheumatoid arthritis, SLE, scleroderma, etc).
• Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
• Known active bacterial, viral, fungal, mycobacterial or other infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
• History of lymphoproliferative or hematologic malignancy. History of any other type of cancer in the past 5 years.