Alexander Disease |
ALX; AxD; demyelinogenic leukodystrophy; dysmyelinogenic leukodystrophy; fibrinoid degeneration of astrocytes; leukodystrophy with Rosenthal fibers |
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
|
Purpose
| 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
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
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
Centocor Research & Development, Inc., PA, USA Clinical Trial, Study Director, Centocor Research & Development, Inc., PA, USA
More Information
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
Resources
- Alexander Disease (Cleveland Clinic)
- Alexander Disease (Cleveland Clinic)

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