Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

Inclusion Criteria: 18-70 years old Diagnosis of Crohn's disease with fistula 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, within 6 months Likely to require surgery in the next 6 months Serious or active infections within 1 year Active infections that require antibiotic therapy Serious infections that require IV antibiotics or hospitalization within 8 weeks Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks Had increased dose of corticosteroids 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 of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks Significant organ dysfunction History of lymphoproliferative disorder History of tuberculosis, mycobacterial infection, or positive chest x-ray History of thrombophlebitis or pulmonary embolus History of immune deficiency or autoimmune disorders (other than Crohn's disease) History of seizure with subtherapeutic levels of anticonvulsive medication within one week