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Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055536
Recruitment Status : Completed
First Posted : March 6, 2003
Last Update Posted : June 16, 2016
Elan Pharmaceuticals
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: natalizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : April 2002
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055536

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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

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Responsible Party: Biogen Identifier: NCT00055536     History of Changes
Other Study ID Numbers: CD306
First Posted: March 6, 2003    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: March 2012
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs