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Open-Label Natalizumab Safety Extension Study

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Natalizumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Michael Panzara, MD, MPH, Study Director, Affiliation: Biogen
Paul O'Connor, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto
Eve Versage, Study Chair, Affiliation: Biogen Idec. Contact for more details

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.

Clinical Details

Official title: An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome: EDSS scores and assessments of relapse.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in, Cambridge, Massachusetts 02142, United States
Additional Information

Starting date: December 2003
Last updated: June 19, 2009

Page last updated: August 23, 2015

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