Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

January 5, 2017 updated by: Biogen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis St. Jan
      • Diepenbeek, Belgium, 3590
        • LUC- University Centre
      • Melsbroek, Belgium, 1820
        • National MS Centrum
  • Canada
      • Halifax, Canada, B3H 1V7
        • MS Research Unit, Center for Clinical Research
      • Ottawa, Canada, K1N 5C7
        • Family Medical Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Services Centre
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital, Neurology
      • London, Ontario, Canada, N6A 5A5
        • University Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook and Women's College and Health Science Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • University of Toronto, MS Clinic, St. Michael's Hospital
    • Quebec
      • Quebec City, Quebec, Canada, J8Y 1W7
        • CHVO Hull Hospital
  • Czech Republic
      • Brno, Czech Republic, 60200
        • Faculty Hospital Brno Bohunice
      • Brno, Czech Republic, 656 91
        • Faculty Hospital St. Anne
      • Hradec Kralove, Czech Republic, 500 05
        • Faculty Hospital of Hradec Kralove
      • Olomouc, Czech Republic, 775 20
        • Faculty Hospital Olomouc
      • Ostrava, Czech Republic, 70852
        • Faculty Hospital Of Ostrava Poruba
      • Pardubice, Czech Republic, 532 03
        • Hospital Pardubice - Department of Neurology
      • Plzen, Czech Republic, 304 60
        • Faculty Hospital Plzen - Clinic of Neurology
      • Prague, Czech Republic, 2 12802
        • General Teaching Hospital - Neurological Department
      • Prague, Czech Republic, 5 105 06
        • Faculty Hospital Motol - Neurological Clinic
  • France
      • Marseille, France, 13385
        • Hopital de la Timone, Service de Neurologie
      • Rennes, France, 35033
        • CHRU - Hopital de Pontchaillou, Service de Neurologie
  • Germany
      • Bochurn, Germany, 44791
        • St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
      • Bydgoszcz, Germany, 85-681
        • Klinika Neurologii
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Academisch Ziekenhuis VU
  • United Kingdom
      • Essex, United Kingdom, NE1 4LP
        • Oldchurch Hospital
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital NHS Trust - Department of Clinical Neurology
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital, Department of Neurology
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital, Kings Neuroscience Center
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
      • Oxford, United Kingdom, OX2 0HE
        • The Radcliffe Infirmary, University Department of Clinical Neurology
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • Stoke on Trent, United Kingdom, ST4 7LN
        • North Staffordshire Royal Infirmary - Neurology Department
    • London
      • Queen Square, London, United Kingdom, WC1N 3BG
        • Institute of Neurology
      • Whitechapel, London, United Kingdom, E1 1BB
        • The Royal London Hospital
      • Wimbledon, London, United Kingdom, SW20 0NE
        • Atkin's Morely Hospital
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Scottsdale
    • California
      • Berkeley, California, United States, 94705
        • East Bay Region Associates in Neurology
      • Davis, California, United States, 95817-2307
        • UC Davis School of Medicine, Department of Neurology
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine, Department of Neurology
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine, Department of Neurology
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center, Department of Neurology
    • Michigan
      • Farmington Hills, Michigan, United States, 48335
        • Michigan Institute for Neurological Disorders
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Gimbel MS Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • CMRRC
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health Sciences University, Department of Neurology
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital, Neurosciences Research
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington MS Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
Natalizumab 300 mg, IV
Drug: Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Other Names:
  • Tysabri
Placebo Comparator: Group 2
Placebo IV infusion
Drug: Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
1 year and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reduction in MRI changes and clinical relapses
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Elan Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Panzara, MD, MPH, Biogen
  • Principal Investigator: Chris Polman, MD, VU Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2001

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C-1801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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