Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
Completed · Phase 2
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT00055536
- Run by
- Biogen
- People needed
- 60
- Starts
- 2002-04-01
- Expected to finish
- 2003-07-01
- Last updated by the study team
- 2016-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Digestive Disease Associates — Gainesville, Florida, United States
- Borland Groover Clinic — Jacksonville, Florida, United States
- Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
- University of Kentucky Medical Center — Lexington, Kentucky, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Mercury Street Medical — Butte, Montana, United States
- Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
- Asheville Gastroenterology — Asheville, North Carolina, United States
- Wake Research Associates — Raleigh, North Carolina, United States
- Boice-Willis Clinic — Rocky Mount, North Carolina, United States
- Columbia Gastroenterology Associates — Columbia, South Carolina, United States
- Gastroenterology Center of the MidSouth — Memphis, Tennessee, United States
- Memphis Gastroenterology Group — Memphis, Tennessee, United States
- Austin Gastroenterology — Austin, Texas, United States
- Internal Medicine Associates — Danville, Virginia, United States
- Gastroenterology Consultants — Virginia Beach, Virginia, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
- Digestive Health Specialists — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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