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Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

NCT00027300 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2017-01-09

No results posted yet for this study

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.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

Natalizumab

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

DRUG

Placebo

Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Michael Panzara, MD, MPH · Biogen

  • Chris Polman, MD · VU Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2004-11-30
Completion
2005-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00027300 on ClinicalTrials.gov