Status:
COMPLETED
Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-72 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00688636
Start Date
January 1 2005
End Date
January 1 2009
Last Update
September 26 2016
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261