A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00078611
- Lead Sponsor
- Biogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Harmony Clinical Research
🇺🇸Oro Valley, Arizona, United States
Advanced Clinical Therapeutics
🇺🇸Tucson, Arizona, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Digestive Diseases Foundation
🇺🇸Los Angeles, California, United States
David Geffen School of Medicine at UCLA, Division of Digestive Diseases
🇺🇸Los Angeles, California, United States
Community Clinical Trials
🇺🇸Orange, California, United States
UCSF / Mt. Zion IBD Center
🇺🇸San Francisco, California, United States
Shared Medical Research Foundation
🇺🇸Tarzana, California, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
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