Lead Sponsor

Facet Biotech

Collaborators

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

No

•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.

•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