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A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

NCT01190839 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2016-02-04

Study results available
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Summary

REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.

Conditions

Interventions

BIOLOGICAL

Infliximab

Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks

DRUG

Placebo

Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks

Sponsors & Collaborators

  • Janssen Biotech, Inc.

    lead INDUSTRY

Principal Investigators

  • Janssen Biotech Inc. Clinical Trial · Janssen Biotech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Netherlands
  • New Zealand
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190839 on ClinicalTrials.gov