Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Centocor, Inc.
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• men/women > 18 years of age

• curative resection/ileocolonic anastomosis for Crohn's disease

• may have received previously received infliximab

• if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery

• if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks

• men and women must use adequate birth control for duration of study and for 6 months after receiving the last infusion

• antibiotics for treatment of Crohn's disease must be discontinued within 12 weeks after surgery; antibiotics are allowable throughout study as long as primary purpose of antibiotic therapy is not for primary treatment of Crohn's disease

• screening lab results must meet screening criteria (hemoglobin = or > 8.5g/dL; Serum glutamic oxaloacetic transaminase ,3 times upper normal limit,platelets =or> 100 x 10 9th/L; lymphocytes count =or> 0.5 x 10 9th/L and neutrophils =or> 1.0 x 10 9th/L

• have a documented negative reaction to a purified protein derivative skin test performed within 3 months prior to baseline

• have a normal chest radiograph results within 3 months prior to baseline

• are capable of providing written informed consent and obtained prior to conducting any protocol-specified procedures

• willing to adhere to the study visit schedule and other protocol requirements

• are considered eligible according to the tuberculosis eligibility assessment, screening and early detection of reactivation rules

• patients who undergo resective surgery and primary ileocolonic anastomosis with a temporary ileostomy upon takedown of the diverting ileostomy.

Exclusion Criteria:

• patients with greater than 10 years of Crohn's disease requiring first resection of a short (<10cm) fibrostenotic stricture

• macroscopically active disease at anastomosis at time of surgery

• presence of stoma

• prior severe infusion reaction to infliximab

• history of anaphylaxis to murine products or other chimeric proteins

• any of the following medications taken within 12 weeks of surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, investigational drugs, or medications targeted at reducing tumor necrosis factor

• have a positive stool culture for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin and have clinically significant signs of an enteric infection at screening

• women who are pregnant, nursing or planning pregnancy during the trial or within 6 months after the last infusion

• patient with active tuberculosis, patient newly diagnosed with latent tuberculosis who's receiving tuberculosis prophylaxis, patient with recent close contact to individual with active tuberculosis

• have or have had opportunistic infection within 6 months of screening

• have chest radiograph within 3 months prior to screening that shows malignancy, infection, or abnormalities suggestive of tuberculosis

• documentation of seropositive for HIV

• documentation of a positive test for hepatitis B surface antigen or a history of documented hepatitis C

• have current signs/symptoms of systemic lupus erythematosus, or severe progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral diseases

• presence of a transplanted solid organ (with exception of corneal transplant > 3 months prior to randomization)

• Have any current or known malignancy or have history of malignancy within 5 years of screening(except for squamous or basal cell carcinoma of the skin that has been fully excised with no evidence of recurrence)

• have history of lymphoproliferative disease or splenomegaly

• have known substance abuse(drug/alcohol)/dependency within the previous 3 years, history of noncompliance with medical regimens, or other condition that may interfere with adherence to protocol requirements

• are unwilling/unable to undergo multiple venipunctures because of poor tolerability or lack of easy access

• known history of demyelinating disease

• a chronic or recurrent infectious disease

• serious infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to randomization

• a serious concomitant illness that may interfere with participation in trial

• concomitant diagnosis/history of congestive heart failure

• current use of prescription doses or chronic/frequent use of non-steroidal anti-inflammatory drugs

• ulcerative colitis

• concurrent participation in another investigative trial

• use of any investigational drug within 30 days prior to randomization