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

Sponsored by:	Centocor Research & Development, Inc.
Information provided by:	Centocor Research & Development, Inc.
ClinicalTrials.gov Identifier:	NCT00207662

Purpose

This is a study of infliximab (Remicade) in subjects with Crohn's disease

Condition	Intervention	Phase
Crohn Disease	Drug: infliximab or placebo	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Immunoglobulins Globulin, Immune Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Centocor Research & Development, Inc.:

Primary Outcome Measures:

Reductions in the signs and symptoms of Crohn's disease

Secondary Outcome Measures:

Clinical remission;reduction in the use corticosteroids; mucosal healing

Estimated Enrollment:	510
Study Start Date:	July 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207662

Sponsors and Collaborators

Centocor Research & Development, Inc.

Investigators

Study Director:

Centocor Research & Development, Inc. Clinical Trial

Centocor Research & Development, Inc.

More Information

Publications of Results:

Rutgeerts P, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Hanauer SB. Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease. Gastroenterology. 2004 Feb;126(2):402-13.

Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

Study ID Numbers:	CR004771
Study First Received:	September 13, 2005
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00207662
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor Research & Development, Inc.:

Crohn's Disease

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Infliximab
Gastrointestinal Diseases

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009