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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2005-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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infliximab or placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No