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

Inclusion Criteria: 18-70 years old Diagnosis of moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's disease, defined as Crohn's Disease Activity Index greater than or equal to 250, C-reactive protein greater than or equal to upper limit of normal, and endoscopic evidence of moderate-to-severe active inflammatory disease Test negative for Clostridium difficile within 3 weeks Signed informed consent, including permission to use protected health information 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