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

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00280956
• Collaborator: Elan Pharmaceuticals (Industry)
• Enrollment: 2,000
• Location: 1
• Duration (Months): 26.1
• Patients Per Site Per Month: 76.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: natalizumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Sep 1, 2004
• Actual Study Completion Date: Sep 1, 2004

Outcome Measures

Primary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

• Biogen
• Elan Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT00280956
• Other Study ID Numbers: CD351
• First Posted: Jan 24, 2006
• Last Update Posted: Jun 16, 2016
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Crohn Disease; Natalizumab

Study Results

No Results Posted as of Jun 16, 2016