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