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
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Recurrence
Intervention: Infliximab; Placebo
Intervention description: Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks; Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 297.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Inflammatory Bowel Disease; infliximab; TNF-alpha

Summary:

      REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in
      an experiment to see if it may be useful in preventing relapse of Crohn's disease after
      surgical resection. This study will compare the effects (both good and bad) of REMICADE
      (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active
      ingredients.
    

Eligibility criteria:

        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.