Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: infliximab; placebo
Intervention description: 5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6; placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Intervention MeSH terms: Infliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No

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