Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

Exclusion Criteria

• •patients with greater than 10 years of Crohn's disease requiring first resection of a short (\<10cm) fibrostenotic stricture
• •macroscopically active disease at anastomosis at time of surgery
• •presence of stoma
• •prior severe infusion reaction to infliximab
• •history of anaphylaxis to murine products or other chimeric proteins
• •any of the following medications taken within 12 weeks of surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, investigational drugs, or medications targeted at reducing tumor necrosis factor
• •have a positive stool culture for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin and have clinically significant signs of an enteric infection at screening
• •women who are pregnant, nursing or planning pregnancy during the trial or within 6 months after the last infusion
• •patient with active tuberculosis, patient newly diagnosed with latent tuberculosis who's receiving tuberculosis prophylaxis, patient with recent close contact to individual with active tuberculosis
• •have or have had opportunistic infection within 6 months of screening
• •have chest radiograph within 3 months prior to screening that shows malignancy, infection, or abnormalities suggestive of tuberculosis
• •documentation of seropositive for HIV
• •documentation of a positive test for hepatitis B surface antigen or a history of documented hepatitis C
• •have current signs/symptoms of systemic lupus erythematosus, or severe progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral diseases
• •presence of a transplanted solid organ (with exception of corneal transplant \> 3 months prior to randomization)
• •Have any current or known malignancy or have history of malignancy within 5 years of screening(except for squamous or basal cell carcinoma of the skin that has been fully excised with no evidence of recurrence)
• •have history of lymphoproliferative disease or splenomegaly
• •have known substance abuse(drug/alcohol)/dependency within the previous 3 years, history of noncompliance with medical regimens, or other condition that may interfere with adherence to protocol requirements
• •are unwilling/unable to undergo multiple venipunctures because of poor tolerability or lack of easy access
• •known history of demyelinating disease
• •a chronic or recurrent infectious disease
• •serious infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to randomization
• •a serious concomitant illness that may interfere with participation in trial
• •concomitant diagnosis/history of congestive heart failure
• •current use of prescription doses or chronic/frequent use of non-steroidal anti-inflammatory drugs
• •ulcerative colitis
• •concurrent participation in another investigative trial
• •use of any investigational drug within 30 days prior to randomization