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Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055367
First received: February 26, 2003
Last updated: March 6, 2012
Last verified: March 2012

February 26, 2003
March 6, 2012
April 2002
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Complete list of historical versions of study NCT00055367 on ClinicalTrials.gov Archive Site
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Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). 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 ELN100226-352.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
30
May 2004
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Male and female patients, 12-17 years of age, who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Females must not be breastfeeding or pregnant, and must not become pregnant during the study.

Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom
 
NCT00055367
CD305
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Elan Pharmaceuticals
Biogen Idec
Not Provided
Elan Pharmaceuticals
March 2012

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