infliximab for the prevention of recurrent crohn's disease after surgery

Conditions: Crohn's Disease

Summary: a randomized, placebo-controlled pilot study to determine endoscopic recurrence of crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo


Eligibility criteria:
inclusion criteria: * men/women \> 18 years of age * curative resection/ileocolonic anastomosis for crohn's disease * may have received previously received infliximab * if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery * if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks * men and women must use adequate birth control for duration of study and for 6 months after receiving the last infusion * antibiotics for treatment of crohn's disease must be discontinued within 12 weeks after surgery; antibiotics are allowable throughout study as long as primary purpose of antibiotic therapy is not for primary treatment of crohn's disease * screening lab results must meet screening criteria (hemoglobin = or \> 8.5g/dl; serum glutamic oxaloacetic transaminase ,3 times upper normal limit,platelets =or\> 100 x 10 9th/l; lymphocytes count =or\> 0.5 x 10 9th/l and neutrophils =or\> 1.0 x 10 9th/l * have a documented negative reaction to a purified protein derivative skin test performed within 3 months prior to baseline * have a normal chest radiograph results within 3 months prior to baseline * are capable of providing written informed consent and obtained prior to conducting any protocol-specified procedures * willing to adhere to the study visit schedule and other protocol requirements * are considered eligible according to the tuberculosis eligibility assessment, screening and early detection of reactivation rules * patients who undergo resective surgery and primary ileocolonic anastomosis with a temporary ileostomy upon takedown of the diverting ileostomy. 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