Open-Label Natalizumab Safety Extension Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Natalizumab	Phase 3

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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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. [ Time Frame: Month 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

EDSS scores and assessments of relapse. [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Enrollment:	1615
Study Start Date:	December 2003
Study Completion Date:	January 2006
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Natalizumab Open-label natalizumab	Drug: Natalizumab Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months Other Name: Tysabri

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276172

Locations

United States, Massachusetts
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, 02142

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:	Michael Panzara, MD, MPH	Biogen Idec
Principal Investigator:	Paul O'Connor, MD	St. Michael's Hospital, Toronto
Study Chair:	Eve Versage	Biogen Idec. Contact for more details

More Information

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier:	NCT00276172 History of Changes
Other Study ID Numbers:	C-1808
Study First Received:	January 11, 2006
Last Updated:	June 19, 2009
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Austria: Federal Ministry of Social Security, Generations, and Consumer Protection Belgium: Directorate General for Medicinal Products Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices Greece: National Organisation for Medicines Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ministry of Health Netherlands: Dutch Healthcare Inspectorate, Medicines Evaluation Board New Zealand: National Institute of Pharmacy Poland: Office for Medicinal Products Spain: Spanish Medicines Agency Sweden: Medicinal Products Agency Switerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases

Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013