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


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Niemann-Pick Disease

Classical Niemann-Pick Disease; DAF syndrome; lipoid histiocytosis (classical phosphatide); Neuronal Cholesterol Lipidosis; NP; NPD; Ophthalmoplegia, Supraoptic Vertical; Sphingomyelin lipidosis; Sphingomyelin/cholesterol lipidosis; Sphingomyelinase deficiency


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

This study is not yet open for patient recruitment.
Verified by Centocor Research & Development, Inc., PA, USA September 2005

Sponsored by: Centocor Research & Development, Inc., PA, USA
Information provided by: Centocor Research & Development, Inc., PA, USA
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 (Remicade) or placebo
Phase III

MedlinePlus related topics:  Crohn''''s Disease

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: 
Primary Outcomes: Reductions in the signs and symptoms of Crohn''''s disease
Secondary Outcomes: Clinical remission;reduction in the use corticosteroids; mucosal healing
Expected Total Enrollment:  510

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 above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00207662

For more information please see the link below or email       info@veritasmedicine.com

Study chairs or principal investigators

Centocor Research & Development, Inc., PA, USA Clinical Trial,  Study Director,  Centocor Research & Development, Inc., PA, USA   

More Information

Study ID Numbers:  CR004771
Last Updated:  September 20, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00207662
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27


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October 11, 2008



Page Updated: October 3, 2005
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