This trial is active, not recruiting.

Condition crohn's disease
Treatments infliximab, placebo
Phase phase 4
Target TNF-alpha
Sponsor University of Pittsburgh
Collaborator Centocor, Inc.
Start date January 2005
End date August 2008
Trial size 24 participants
Trial identifier NCT00688636, C0168X75


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Active Comparator)
infliximab Remicade
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
(Placebo Comparator)
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Primary Outcomes

Endoscopic remission: the proportion of patients in endoscopic remission at one year
time frame: one year

Secondary Outcomes

Clinical remission at one year: defined by Crohn's Disease Activity Index (CDAI)<150
time frame: one year
Histological recurrence of Crohn's disease as determined by biopsies
time frame: one year

Eligibility Criteria

Male or female participants from 18 years up to 72 years old.

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

Additional Information

Principal investigator Miguel D Regueiro, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by University of Pittsburgh.