Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT00055536|
Recruitment Status : Completed
First Posted : March 6, 2003
Last Update Posted : June 16, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
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 ClinicalTrials.gov identifier (NCT number): NCT00055536