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