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A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn’s Disease

This study has been completed.

Sponsors and Collaborators: Elan Pharmaceuticals
Biogen Idec
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00078611
  Purpose

The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn’s Disease.


Condition Intervention Phase
Crohn's Disease
Drug: Antegren(TM) (natalizumab)
Phase III

Genetics Home Reference related topics:   Crohn disease   

MedlinePlus related topics:   Crohn's Disease   

ChemIDplus related topics:   Natalizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn’s Disease With Elevated C-Reactive Protein

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment:   462
Study Start Date:   February 2004

Detailed Description:

Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn’s disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn’s disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn’s disease. Individuals with Crohn’s disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Males and females 18 years of age or older
  • Diagnosis of Crohn’s disease for at least 6 months
  • Females must not be pregnant or breastfeeding
  • Must not have previously taken natalizumab
  • Use of some other Crohn’s disease medications is permitted, but will be closely supervised
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078611

Show 75 study locations  Show 75 Study Locations

Sponsors and Collaborators
Elan Pharmaceuticals
Biogen Idec
  More Information

Study ID Numbers:   ELN100226-CD307
First Received:   March 1, 2004
Last Updated:   October 26, 2005
ClinicalTrials.gov Identifier:   NCT00078611
Health Authority:   United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Crohn's disease  
Inflammatory Bowel Disease  
IBD  
Gastroenterology
Regional Enteritis
Colitis

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Enteritis
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Colitis

ClinicalTrials.gov processed this record on September 04, 2008




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