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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00207662

Enrollment

580

Registered

2005-09-21

Start date

2000-07-31

Completion date

2005-11-30

Last updated

2010-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn's Disease

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.

Interventions

DRUGinfliximab or placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reductions in the signs and symptoms of Crohn's disease	—

Secondary

Measure	Time frame
Clinical remission;reduction in the use corticosteroids; mucosal healing	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026