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

Tracking Information
First Received Date ^ICMJE	March 1, 2004
Last Updated Date	October 26, 2005
Start Date ^ICMJE	February 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00078611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn’s Disease
Official Title ^ICMJE	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
Brief Summary	The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn’s Disease.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Crohn's Disease
Intervention ^ICMJE	Drug: Antegren(TM) (natalizumab)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	462
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00078611
Responsible Party
Study ID Numbers ^ICMJE	ELN100226-CD307
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE	Biogen Idec
Investigators ^ICMJE
Information Provided By	Elan Pharmaceuticals
Verification Date	October 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP