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Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Natalizumab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Michael Panzara, MD, MPH, Study Director, Affiliation: Biogen
Richard A Rudick, MD, Principal Investigator, Affiliation: The Cleveland Clinic

Summary

The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (MS).

Clinical Details

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.

Secondary outcome: If this combination reduces MRI lesions and the overall rate of clinical relapses

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4

- Between the ages of 18 and 55, inclusive

- Baseline EDSS score between 0. 0 and 5. 0, inclusive

- Have been treated with Avonex for at least the 12 months prior to randomization

- Have experienced at least one relapse (while on Avonex) within the 12 months prior to

randomization.

- Cranial MRI scan demonstrating lesions 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 within 50 days of randomization

- A clinically significant infectious illness within 30 days prior to randomization

- History of, or abnormal lab result, indicative of significant disease, that in the

opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex 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 at Screening Visit

Locations and Contacts

Universitatsklinik fur Neurologie, Graz 8036, Austria

Universitatsklinik fur Neurologie, Innsbruck 6020, Austria

Hopital Universitaire U.L.B. Erasme, Brussels 1780, Belgium

Elisabeth Ziekenhuis, Sijsele 8340, Belgium

Hopital Pellegrin Tripode, Neurologie, Bordeaux 33076, France

Hopital neurologique Pierre Werth, Lyon 69394, France

Judisches Krankenhaus, Berlin 13347, Germany

Universitaetsklinikum Giessen, Oberarzt Neurologie, Giessen 35390, Germany

Medizinische Hochschule Hannover, Neurologische Klinik, Hannover 30625, Germany

Neurologische Abteilung, Henningsdorf 16761, Germany

Städtische Kliniken Osnabrück, Osnabrück 49076, Germany

Asklepios Klinik Schildautal, Seesen/Harz 38723, Germany

Fachbereich Neurologie und Klinische Neurophysiologie, Wiesbaden 65191, Germany

Hadassah Hebrew Uni Hospital, Department of Neurology, Jerusalem, Israel

Sheba Medical Center, MS Center, Tel Hashomer 52621, Israel

Universita di Genova, Clinica Neurologica, Genova 16132, Italy

University of Alabama-Birmingham, Department of Neurology, Birmingham, Alabama 35233, United States

Phoenix Neurological Associates, Ltd., Phoenix, Arizona 85008, United States

University of Arkansas For Medical Sciences, Little Rock, Arkansas 72205, United States

University of California - Irvine, Irvine, California 92697, United States

USC MS Comprehensive Care Center, Los Angeles, California 90033, United States

Kaiser-Permanente Medical Center, Redwood City, California 94063, United States

MS Center at UCSF, San Francisco, California 94117, United States

Healthsouth Rehabilitation Hospital, Colorado Springs, Colorado 80910, United States

University of Colorado MS Center, Denver, Colorado 80262, United States

Griffin Hospital, Derby, Connecticut 06418, United States

George Washington University MS Center, Washington, District of Columbia 20037, United States

Georgetown Univesity Hospital, Research Pharmacy, Washington, District of Columbia 20007, United States

North Ridge NeuroScience Center, Ft. Lauderdale, Florida 33334, United States

Maitland Neurology, Maitland, Florida 32751, United States

University of Miami, Department of Neurology, Miami, Florida 33136, United States

The Multiple Sclerosis Center of Atlanta, Atlanta, Georgia 30327, United States

Marietta Neurological Associates, Marietta, Georgia 30060, United States

Northwestern University, Department of Neurology, Chicago, Illinois 60611, United States

Rush-Presbyterian St. Luke's Medical Center, Chicago, Illinois 60612, United States

Alexian Brothers Center for Clinical Research, Elk Grove Village, Illinois 60007, United States

Loyola Medical Center, Maywood, Illinois 60153, United States

Consultants in Neurology Northbrook, Northbrook, Illinois 60062, United States

Springfield Clinic Neuroscience Institute, Springfield, Illinois 62702, United States

Indiana University Medical Center, Indianapolis, Indiana 46202, United States

Mercy Hospital Outpatient Pharmacy, Des Moines, Iowa 50314, United States

LSU Neurolgoy Clinic in New Orleans, New Orleans, Louisiana 70112, United States

Maine Neurology, Scarborough, Maine 04074-8926, United States

University of Maryland Hospital, Department of Neurology, Baltimore, Maryland 21201, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655-0138, United States

Henry Ford Hospital, Detroit, Michigan 48202-2608, United States

Michigan State University MS Clinic, East Lansing, Michigan 48824, United States

Michigan Institute for Neurological Disorders, Farmington Hills, Michigan 48334, United States

Noran Neurological Clinic, Minneapolis, Minnesota 55404, United States

University of Mississippi Medical Center, Jackson, Mississippi 39216-4505, United States

St. John's Mercy Medical Center, St. Louis, Missouri 63141, United States

Bernard W. Gimbel MS Center, Teaneck, New Jersey 07666, United States

Albany Medical Center, Albany, New York 12208, United States

Upstate Clinical Research, LLC, Albany, New York 12205, United States

Maimonides Medical Center, Division of Neurology, Brooklyn, New York 11219, United States

Buffalo General Hospital, Department of Neurology, Buffalo, New York 14203, United States

MS Care Center, New York, New York 10003, United States

New York Hospital - Cornell Medical Center, New York, New York 10021, United States

New York State Psychiatric Institution, New York, New York 10032, United States

St. Luke's Roosevelt Hospital, MS Research & Treatment Center, New York, New York 10019, United States

Strong Health Pharmacy Services, Rochester, New York 14642, United States

Staten Island University Hospital, Staten Island, New York 10305, United States

University Hospital at Stony Brook, Stony Brook, New York 11794, United States

SUNY Upstate Medical University, Syracuse, New York 13210, United States

MS Center at Carolinas Medical Center, Charlotte, North Carolina 28232-2861, United States

Raleigh Neurology Associates, Raleigh, North Carolina 27607, United States

Wake Forest University School of Medicine, Department of Neurology, Winston-Salem, North Carolina 27157, United States

Riverhills Neurology, Cincinnati, Ohio 45219, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Providence Saint Vincent Medical Center, Portland, Oregon 97225, United States

Geisinger Medical Center, Danville, Pennsylvania 17822, United States

Greenstein Neurology Associates & MS Institute, Philadelphia, Pennsylvania 19146, United States

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Allegheny Singer Research Institute, Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh, Department of Neurology, Pittsburgh, Pennsylvania 15213, United States

University of Tennessee - Memphis, Memphis, Tennessee 38163, United States

Vanderbilt Medical Center, Nashville, Tennessee 37215, United States

Option Care Infusion, Dallas, Texas 75226, United States

UTSW Medical School, Dallas, Texas 75235-9036, United States

Baylor Methodist International MS Center, Houston, Texas 77030, United States

Central Texas Neurology, Round Rock, Texas 78681, United States

Fletcher Allen Health Care, Burlington, Vermont 05401, United States

University of Virginia Health Sciences, Charlottesville, Virginia 22908, United States

Neurological Associates, Inc., Richmond, Virginia 23226, United States

MS Research Center, Seattle, Washington 98195, United States

Virginia Mason Medical Center, Seattle, Washington 98111, United States

St. Francis Hospital, Center for Neurological Disorders, Milwaukee, Wisconsin 53215, United States

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.

MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen.

Starting date: January 2002
Last updated: June 17, 2009

Page last updated: August 23, 2015

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