Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease

Exclusion Criteria

• •History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
• •Pregnant or nursing
• •HIV, Hepatitis B or Hepatitis C infection
• •Presence of obstructive symptoms, confirmed by endoscopy
• •Serious infections within 12 months
• •Active infections that require antibiotic therapy
• •Started or changed dose of sulfasalazine, 5-aminosalicylic acid; or antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
• •Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks
• •Increase dose of corticosteroid medication within 2 weeks
• •Received a live vaccine within 6 weeks
• •Received any monoclonal antibodies or investigational agents within 3 months
• •Received cyclosporine or tacrolimus (FK506) within 4 weeks
• •Dose change or discontinuation from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
• •Significant organ dysfunction
• •Likely to require surgery in the next 6 months
• •History of lymphoproliferative disorder
• •History of tuberculosis or mycobacteria infection or positive chest x-ray
• •History of thrombophlebitis or pulmonary embolus
• •History of immune deficiency or autoimmune disorders other than Crohn's
• •History of subtherapeutic blood levels of anticonvulsive medications within 1 week