Ensayos clínicos

This study has been terminated

Inclusion Criteria

• Has a documented diagnosis of Crohn's Disease confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
• Has undergone an ileocolonic surgical resection
• Must also be at an increased risk of recurrence of active CD
• Must not have previously discontinued infliximab as a result of tolerability issues or 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
• Must undergo screening for HBV
• Baseline CDAI < 200
• Has adequate blood and liver test values

Exclusion Criteria

• Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
• Has had 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
• Has macroscopically active CD which was not resected at the time of surgery
• Does not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
• Has evidence of an active infection at the time of randomization or has had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis) within 6 months prior to screening
• Has or has 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
• Has 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)
• Has 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