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

Phase 4

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00280956
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2006-01-21
• Study First Submitted QC: 2006-01-21
• Study First Posted: 2006-01-24
• Status Verified: 2012-03
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (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