A Study to Evaluate Remicade (Infliximab) for the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection and are at an Increased Risk of Recurrence

Overview

About this study

The purpose of this study is to evaluate the effects of Remicade (infliximab) for the treatment of active Crohn's disease and  may be useful in preventing a relapse of Crohn's disease after surgical resection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Edward Loftus, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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