Open-Label Natalizumab Safety Extension Study

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Natalizumab

• Registration Number: NCT00276172
• Lead Sponsor: Biogen

Brief Summary

The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2005-10
• Study Completion: 2006-01
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-19
• Last Update Posted: 2009-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1615

Inclusion Criteria

• Must give written informed consent.
• Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

Exclusion Criteria

• History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
• History of severe allergic or anaphylactic reactions or known drug hypersensitivity
• A clinically significant infectious illness within 30 days prior to study entry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Natalizumab	Natalizumab	Open-label natalizumab

Primary Outcome Measures

Name	Time	Method
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.	Month 24

Secondary Outcome Measures

Name	Time	Method
EDSS scores and assessments of relapse.	Month 24

Trial Locations

Locations (1)

Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in; 🇺🇸 Cambridge, Massachusetts, United States