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A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00207662
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 27, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a study of infliximab (Remicade) in subjects with Crohn's disease

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: infliximab or placebo Phase 3

Detailed Description:

Crohn's disease is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (formation of pus) of the bowel. The purpose of this study is to investigate the safety and therapeutic effect of two different doses of an anti-TNFα (tumor necrosis factor) antibody (a protein) given multiple times compared to a single dose followed by placebo (inactive substance). The name of the antibody is infliximab (Remicade) The goal of the study is to evaluate whether patients respond longer to a single dose of infliximab or to repeated doses of infliximab.

Subjects will receive an infusion of infliximab at week 0 followed by infusions of infliximab or placebo at weeks 2, 6, 14 and every 8 weeks until week 54. Patients who lose response are eligible for additional infliximab treatment.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: ACCENT I - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long-term Treatment of Patients With Moderately to Severely Active Crohn's Disease
Study Start Date : July 2000
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Reductions in the signs and symptoms of Crohn's disease

Secondary Outcome Measures :
  1. Clinical remission;reduction in the use corticosteroids; mucosal healing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women >=18 years of age
  • Diagnosis of Crohn's
  • Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography or endoscopy

Exclusion Criteria:

  • Local manifestations of Crohn's disease such as strictures, abscesses, or other disease
  • Surgery for bowel diversion with placement of a stoma within 3 months prior to beginning the study
  • Positive stool culture
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00207662


Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
More Information