A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

The purpose of this study is to assess the effects of REMICADE (infliximab) in preventing
relapse of Crohn's disease after surgical resection. Patients will be assigned to a group
that will initially receive either infliximab or placebo. Each patient who is allowed to
join the study is put into a group by chance (randomly), like flipping a coin. There is a
possibility that patients can receive both the study drug and placebo at different times in
the study. If a patient is initially randomized to receive placebo, and their study doctor
confirms that they have had a return of active Crohn's Disease symptoms, they can receive
infliximab. If a patient is initially randomized to receive infliximab, and their study
doctor confirms that they are experiencing symptoms of Crohn's Disease, they may receive an
increase in their infliximab dose. Infusions will be administered at Week 0 and then every 8
weeks thereafter through Week 200. The study will use a measure of Crohn's Disease activity
that will be evaluated at each visit and at any time the patient has symptoms suggestive of
their disease getting worse in order to capture recurrence. During the study, patients who
meet the study definition of clinical recurrence will be eligible to have a blinded
infliximab dose increase of 5 mg/kg. In other words, patients receiving placebo would
receive infliximab 5 mg/kg, and patients receiving infliximab 5 mg/kg would have a dose
increase to 10 mg/kg. Approximately 175 sites will be utilized, and approximately 290
patients will be enrolled. The interval between the first and last dose of study agent is
200 weeks. The planned duration of study participation is a maximum of 209 weeks (with a
1-week screening period, a 200-week treatment period, and a final study visit at Week 208).
Group I (infliximab infusions): infliximab (5 mg/kg) will be administered by intravenous
(IV) infusion at Week 0 and every 8 weeks thereafter through Week 200. Group II (placebo
infusions): placebo will be administered by IV infusion at Week 0 and every 8 weeks
thereafter through Week 200

Inclusion Criteria:

- Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or
radiologic studies prior to resection or by tissue obtained at resection

- Have undergone an ileocolonic surgical resection

- Patients must also be at an increased risk of recurrence of active CD

- Patients must not have previously discontinued infliximab as a result of tolerability
issues or they must be naive to treatment with infliximab. Provided patients meet the
above criteria pertaining to infliximab, they are eligible to enroll if they received
prior treatment with adalimumab and/or certolizumab

- Patients must undergo screening for HBV

- Baseline CDAI < 200

- Have adequate blood and liver test values

Exclusion Criteria:

- Have a history of latent or active granulomatous infection, including histoplasmosis
or coccidioidomycosis, prior to screening

- Have a chest radiograph within 3 months prior to the first infusion of study agent
that shows a clinically significant abnormality, such as a malignancy or infection,
or any abnormalities suggestive of TB

- Have macroscopically active CD which was not resected at the time of surgery

- Do not meet the criteria for being at an increased risk of postoperative recurrence
of active CD as outlined in the inclusion criteria

- Have evidence of an active infection at the time of randomization or have had a
serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis),
within 6 months prior to screening

- Have or have had an opportunistic infection (e.g., herpes zoster [shingles],
cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria
other than TB) within 6 months prior to screening

- Have any known malignancy or history of malignancy within the 5-year period prior to
screening (with the exception of squamous or basal cell carcinoma of the skin that
has been completely excised without evidence of recurrence)

- Have any condition that, in the opinion of the investigator, would compromise the
well-being of the patient or the study or prevent the patient from meeting or
performing study requirements.