Open Label Natalizumab Safety Extension Study for Subjects With Crohn's Disease

This study has been completed.

Sponsors and Collaborators:	Elan Pharmaceuticals Biogen Idec
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00280956

Purpose

The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn’s Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.

Condition	Intervention	Phase
Crohn's Disease	Drug: Natalizumab	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Natalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn’s Disease Subjects Who Have Previously Participated in Antegren Crohn’s Disease Studies

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:

To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.

Estimated Enrollment:	1000
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280956

Locations

United States, California
Performed only at CD251, CD301, CD303, CD306, and CD307 sites globally. No general public enrollment. The study is managed from the office of Elan Pharmaceuticals, Inc. in
San Diego, California, United States, 92121

Sponsors and Collaborators

Elan Pharmaceuticals

Biogen Idec

Investigators

Study Director:

Jeffrey Bornstein, MD

Elan Pharmaceuticals

More Information

Study ID Numbers:	CD351
Study First Received:	January 21, 2006
Last Updated:	January 21, 2006
ClinicalTrials.gov Identifier:	NCT00280956
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on January 15, 2009