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

This study has been completed.
Sponsor:
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
  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:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 60
Study Start Date: April 2002
Study Completion Date: July 2003
  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 April 17, 2014