Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

This study has been completed.

Sponsors and Collaborators:	Biogen Idec Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00030966

Purpose

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab	Phase III

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab Interferons Interferon beta Interferon-beta Interferon beta 1a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

The primary outcome objective was to determine whether add natalizumab to Avonex reduces the number clinical relapses and the level of disability at 1 year

Secondary Outcome Measures:

If this combination reduces MRI lesions and the overall rate of clinical relapses

Estimated Enrollment:	1200
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Male and female subjects between 18 and 50 years of age who have a diagnosis of relapsing remitting multiple sclerosis

AND

who have been treated with Avonex for at least 12 months prior to study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030966

Show 88 Study Locations

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators

Study Director:	Michael Panzara, MD, MPH	Biogen Idec
Principal Investigator:	Richard A Rudick, MD	The Cleveland Clinic

More Information

The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen. This link exits the ClinicalTrials.gov site

Publications of Results:

Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23.

Study ID Numbers:	C-1802
Study First Received:	February 15, 2002
Last Updated:	June 7, 2006
ClinicalTrials.gov Identifier:	NCT00030966
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Multiple Sclerosis
MS

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta 1a
Interferon-beta

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009