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

NCT ID: NCT00688636

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-01-31

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 infliximab or placebo

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

infliximab

Intervention Type: DRUG

5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Interventions

infliximab

5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Intervention Type: DRUG

placebo

placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6

Intervention Type: DRUG

Other Intervention Names

Remicade

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Miguel Regueiro

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel D Regueiro, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Regueiro M, Schraut W, Baidoo L, Kip KE, Sepulveda AR, Pesci M, Harrison J, Plevy SE. Infliximab prevents Crohn's disease recurrence after ileal resection. Gastroenterology. 2009 Feb;136(2):441-50.e1; quiz 716. doi: 10.1053/j.gastro.2008.10.051. Epub 2008 Oct 31.

Reference Type: RESULT

PMID: 19109962 (View on PubMed)

Other Identifiers

C0168X75

Identifier Type: -

Identifier Source: org_study_id