Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00027300

First Posted: December 3, 2001

Last Update Posted: January 9, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

Elan Pharmaceuticals

Information provided by:

Biogen

Tracking Information

First Submitted Date ^ICMJE

November 30, 2001

First Posted Date ^ICMJE

December 3, 2001

Last Update Posted Date

January 9, 2017

Start Date ^ICMJE

November 2001

Primary Completion Date

November 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00027300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Reduction in MRI changes and clinical relapses [ Time Frame: 1 year ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.

Other Name: Tysabri
Drug: Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Study Arms

Experimental: Group 1
Natalizumab 300 mg, IV

Intervention: Drug: Natalizumab
Placebo Comparator: Group 2
Placebo IV infusion

Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

900

Completion Date

January 2005

Primary Completion Date

November 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Canada, Czech Republic, France, Germany, Netherlands, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00027300

Other Study ID Numbers ^ICMJE

C-1801

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Biogen Idec Medical Director, Biogen Idec

Study Sponsor ^ICMJE

Biogen

Collaborators ^ICMJE

Elan Pharmaceuticals

Investigators ^ICMJE

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

PRS Account

Biogen

Verification Date

January 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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