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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055536
First Posted: March 6, 2003
Last Update Posted: June 16, 2016
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.
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
March 4, 2003
March 6, 2003
June 16, 2016
April 2002
July 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00055536 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Crohn's Disease
Drug: natalizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2003
July 2003   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00055536
CD306
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Biogen
Biogen
Elan Pharmaceuticals
Not Provided
Biogen
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP