Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

Phase 3

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Natalizumab; Drug: Placebo

• Registration Number: NCT00027300
• Lead Sponsor: Biogen

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 available

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2001-11-30
• Study First Submitted QC: 2001-11-30
• Study First Posted: 2001-12-03
• Primary Completion: 2004-11
• Study Completion: 2005-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Natalizumab	Natalizumab 300 mg, IV
Group 2	Placebo	Placebo IV infusion

Primary Outcome Measures

Name	Time	Method
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.	1 year and 2 years

Secondary Outcome Measures

Name	Time	Method
Reduction in MRI changes and clinical relapses	1 year

Trial Locations

Locations (53)

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

East Bay Region Associates in Neurology; 🇺🇸 Berkeley, California, United States

UC Davis School of Medicine, Department of Neurology; 🇺🇸 Davis, California, United States

Yale University School of Medicine, Department of Neurology; 🇺🇸 New Haven, Connecticut, United States

University of Miami School of Medicine, Department of Neurology; 🇺🇸 Miami, Florida, United States

University of Kansas Medical Center, Department of Neurology; 🇺🇸 Kansas City, Kansas, United States

Michigan Institute for Neurological Disorders; 🇺🇸 Farmington Hills, Michigan, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Gimbel MS Center; 🇺🇸 Teaneck, New Jersey, United States

CMRRC; 🇺🇸 Albuquerque, New Mexico, United States

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