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| Sponsors and Collaborators: |
Elan Pharmaceuticals Biogen Idec |
|---|---|
| Information provided by: | Elan Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00055536 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: Natalizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn’s Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| United States, Florida | |
| Borland Groover Clinic | |
| Jacksonville, Florida, United States, 32223 | |
| Digestive Disease Associates | |
| Gainesville, Florida, United States, 32605 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Montana | |
| Mercury Street Medical | |
| Butte, Montana, United States, 59701 | |
| United States, New York | |
| Long Island Clinical Research Associates, LLP | |
| Great Neck, New York, United States, 11021 | |
| United States, North Carolina | |
| Asheville Gastroenterology | |
| Asheville, North Carolina, United States, 28801 | |
| Boice-Willis Clinic | |
| Rocky Mount, North Carolina, United States, 27804 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, South Carolina | |
| Columbia Gastroenterology Associates | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| Gastroenterology Center of the MidSouth | |
| Memphis, Tennessee, United States, 38120 | |
| Memphis Gastroenterology Group | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Austin Gastroenterology | |
| Austin, Texas, United States, 78745 | |
| United States, Virginia | |
| Gastroenterology Consultants | |
| Virginia Beach, Virginia, United States, 23455 | |
| Internal Medicine Associates | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Digestive Health Specialists | |
| Tacoma, Washington, United States, 98405 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
More Information
| Study ID Numbers: | CD306 |
| Study First Received: | March 4, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00055536 |
| Health Authority: | United States: Food and Drug Administration |
|
Digestive System Diseases Infliximab Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
