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

• Percentage of Participants With Clinical Recurrence of Crohn's Disease (CD) Prior to or at Week 76 [ Time Frame: Baseline up to Week 76 ] [ Designated as safety issue: No ]
  Clinical recurrence criteria: either 1) a greater than or equal to(>=) 70-point increase from baseline in CD Activity Index (CDAI), 2) a CDAI score of >=200, 3) evidence of endoscopic recurrence (defined as a ileal Rutgeert's score of >=i2 at anastomotic site or its equivalent elsewhere in gastrointestinal tract),4) a negative stool test for Clostridium difficile toxin; if, in opinion of Investigator, participant's symptoms are predominantly diarrheal; or at least 1 of followings: 1) developing a new draining external fistula; 2) re-opening and draining of a previously existing external fistula; 3) developing a new internal fistula; 4) developing a new perianal abscess or 5) developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to or at Week 76 were considered to have clinical recurrence.
  
  

• Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76 [ Time Frame: Baseline up to Week 76 ] [ Designated as safety issue: No ]
  Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.
  
  

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