A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT00207662|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: infliximab or placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||580 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Completion Date :||November 2005|
- Reductions in the signs and symptoms of Crohn's disease
- Clinical remission;reduction in the use corticosteroids; mucosal healing
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
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|