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

Crohn's Disease Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00688636
• Other study ID #: C0168X75
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 29, 2008
• Last updated: June 2, 2008
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: May 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• infliximab
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
• placebo
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Centocor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic remission: the proportion of patients in endoscopic remission at one year		one year	No
Secondary	Clinical remission at one year: defined by Crohn's Disease Activity Index (CDAI)<150		one year	No
Secondary	Histological recurrence of Crohn's disease as determined by biopsies		one year	No