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

This study has been completed.
Information provided by:
Elan Pharmaceuticals Identifier:
First received: January 21, 2006
Last updated: March 6, 2012
Last verified: March 2012
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:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00280956

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
Study Director: Jeffrey Bornstein, MD Elan Pharmaceuticals
  More Information 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
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2016