Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
This study has been completed.
Sponsor:
Elan Pharmaceuticals
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055536
First received: March 4, 2003
Last updated: March 6, 2012
Last verified: March 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Elan Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Male and female patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)
- Women must not be breastfeeding or pregnant, and must not become pregnant during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055536
Locations
| United States, Florida | |
| Digestive Disease Associates | |
| Gainesville, Florida, United States, 32605 | |
| Borland Groover Clinic | |
| Jacksonville, Florida, United States, 32223 | |
| 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 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| Boice-Willis Clinic | |
| Rocky Mount, North Carolina, United States, 27804 | |
| 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 | |
| Internal Medicine Associates | |
| Danville, Virginia, United States, 24541 | |
| Gastroenterology Consultants | |
| Virginia Beach, Virginia, United States, 23455 | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
| Digestive Health Specialists | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Elan Pharmaceuticals
Biogen Idec
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00055536 History of Changes |
| Other Study ID Numbers: | CD306 |
| Study First Received: | March 4, 2003 |
| Last Updated: | March 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Infliximab |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013