Back to resultsA Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
Primary Purpose
Crohn Disease
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
infliximab or placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00207662
Brief Title
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a study of infliximab (Remicade) in subjects with Crohn's disease
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
580 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
infliximab or placebo
Primary Outcome Measure Information:
Title
Reductions in the signs and symptoms of Crohn's disease
Secondary Outcome Measure Information:
Title
Clinical remission;reduction in the use corticosteroids; mucosal healing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
14762776
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):402-13. doi: 10.1053/j.gastro.2003.11.014.
Results Reference
result
PubMed Identifier
12047962
Citation
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. doi: 10.1016/S0140-6736(02)08512-4.
Results Reference
result
PubMed Identifier
22251435
Citation
Reinisch W, Wang Y, Oddens BJ, Link R. C-reactive protein, an indicator for maintained response or remission to infliximab in patients with Crohn's disease: a post-hoc analysis from ACCENT I. Aliment Pharmacol Ther. 2012 Mar;35(5):568-76. doi: 10.1111/j.1365-2036.2011.04987.x. Epub 2012 Jan 18.
Results Reference
derived
Learn more about this trial
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
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