Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00055536
- Lead Sponsor
- Biogen
- Brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. 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.
Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 (18)
Wake Research Associates
๐บ๐ธRaleigh, North Carolina, United States
University of Kentucky Medical Center
๐บ๐ธLexington, Kentucky, United States
Memphis Gastroenterology Group
๐บ๐ธMemphis, Tennessee, United States
Digestive Disease Associates
๐บ๐ธGainesville, Florida, United States
Borland Groover Clinic
๐บ๐ธJacksonville, Florida, United States
Internal Medicine Associates
๐บ๐ธDanville, Virginia, United States
Massachusetts General Hospital
๐บ๐ธBoston, Massachusetts, United States
Virginia Mason Medical Center
๐บ๐ธSeattle, Washington, United States
Gastroenterology Consultants
๐บ๐ธVirginia Beach, Virginia, United States
Atlanta Gastroenterology Associates
๐บ๐ธAtlanta, Georgia, United States
Asheville Gastroenterology
๐บ๐ธAsheville, North Carolina, United States
Mercury Street Medical
๐บ๐ธButte, Montana, United States
Long Island Clinical Research Associates, LLP
๐บ๐ธGreat Neck, New York, United States
Boice-Willis Clinic
๐บ๐ธRocky Mount, North Carolina, United States
Columbia Gastroenterology Associates
๐บ๐ธColumbia, South Carolina, United States
Gastroenterology Center of the MidSouth
๐บ๐ธMemphis, Tennessee, United States
Austin Gastroenterology
๐บ๐ธAustin, Texas, United States
Digestive Health Specialists
๐บ๐ธTacoma, Washington, United States