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Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease - Article


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Crohn's Disease

Crohn's disease; Crohn//'s disease; Inflamatory Bowel Disease; Inflammatory Bowel Disease, Crohn's




Clinical Trial: Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

This study is no longer recruiting patients.

Sponsors and Collaborators: Elan Pharmaceuticals
Biogen Idec
Information provided by: Elan Pharmaceuticals

Purpose

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Condition Treatment or Intervention Phase
Crohn's Disease
 Drug: natalizumab
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: A Phase 3, international, multicenter, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of intravenous Antegren (natalizumab) in maintaining clinical response and remission in subjects with Crohn's disease

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

More Information

Study ID Numbers:  CD303
Record last reviewed:  January 2003
Last Updated:  October 13, 2004
Record first received:  April 3, 2002
ClinicalTrials.gov Identifier:  NCT00032786
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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December 4, 2008



Page Updated: May 11, 2006
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