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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00078611
First received: March 1, 2004
Last updated: March 6, 2012
Last verified: March 2012

March 1, 2004
March 6, 2012
March 2004
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Complete list of historical versions of study NCT00078611 on ClinicalTrials.gov Archive Site
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A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: Antegren(TM) (natalizumab)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
462
March 2005
Not Provided
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00078611
ELN100226-CD307
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Elan Pharmaceuticals
Biogen Idec
Not Provided
Elan Pharmaceuticals
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP