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Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT00688636•University of Pittsburgh

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

Eligibility

Age

18 - 72 years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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
+18 more criteria

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

August 1, 2008

Completion Date

January 1, 2009

Last Updated

September 26, 2016

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

infliximab

DRUG

placebo

DRUG

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease