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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207662
• Other study ID #: CR004771
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: April 26, 2010
• Start date: July 2000
• Est. completion date: November 2005

Study information

• Verified date: April 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• infliximab or placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (2)

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) — View Citation

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in the signs and symptoms of Crohn's disease
Secondary	Clinical remission;reduction in the use corticosteroids; mucosal healing