Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis - Full Text View

Sponsor:	Biogen Idec
Collaborator:	Elan Pharmaceuticals
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00027300

Purpose

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Dose Comparison Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

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 primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	900
Study Start Date:	November 2001
Study Completion Date:	January 2005
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Natalizumab 300 mg, IV	Drug: Natalizumab Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Group 2: Placebo Comparator Placebo IV infusion	Drug: Placebo Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of MS, as defined by McDonald et al., criteria # 1-4 (McDonald et al., 2001)
Between the ages of 18 and 50, inclusive.
Baseline EDSS score between 0.0 and 5.0, inclusive.
Have experienced at least one relapse within the 12 months prior to randomization.
Cranial MRI scan demonstrating lesion(s) consistent with MS.
Have given written informed consent to participate in the study.

Exclusion Criteria:

Primary progressive, secondary progressive, or progressive relapsing MS.
MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
A clinically significant infectious illness within 30 days prior to randomization.
History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent for 116 weeks.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
Unable to perform the Timed 25-foot Walk, 9HPT, and PASAT 3.
Abnormal blood tests performed at the Screening Visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027300

Show 53 Study Locations

Sponsors and Collaborators

Biogen Idec

Elan Pharmaceuticals

Investigators

Study Director:	Michael Panzara, MD, MPH	Biogen Idec
Principal Investigator:	Chris Polman, MD	VU Medical Centre

More Information

Additional 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:

Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910.

Responsible Party:	Biogen Idec ( Biogen Idec Medical Director )
Study ID Numbers:	C-1801
Study First Received:	November 30, 2001
Last Updated:	June 15, 2009
ClinicalTrials.gov Identifier:	NCT00027300 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

Relapsing Remitting Multiple Sclerosis

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

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

ClinicalTrials.gov processed this record on March 18, 2010