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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00280956
First received: January 21, 2006
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Natalizumab
U.S. FDA Resources

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: 2000
Study Start Date: July 2002
Study Completion Date: September 2004
  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

No publications provided

ClinicalTrials.gov Identifier: NCT00280956     History of Changes
Other Study ID Numbers: CD351
Study First Received: January 21, 2006
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

ClinicalTrials.gov processed this record on May 22, 2013