Expired Study
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Pittsburgh, Pennsylvania 15261


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


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-MP,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; SGOT ,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 PPD 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 TNF - 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 TB, patient newly diagnosed with latent TB who's receiving TB prophylaxis, patient with recent close contact to individual with active TB - 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 TB - 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 CHF - current use of prescription doses or chronic/frequent use of NSAIDs - ulcerative colitis - concurrent participation in another investigative trial - use of any investigational drug within 30 days prior to randomization



Primary Contact:

Principal Investigator
Miguel D Regueiro, M.D.
University of Pittsburgh

Backup Contact:


Location Contact:

Pittsburgh, Pennsylvania 15261
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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