Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
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1 Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis Status: Completed Study Phase: Phase 3 Start Date: January 2002 Completion Date: December 2005 Condition(s): Multiple Sclerosis, Relapsing-Remitting Full Title of Study 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 Overview 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). Study Details Study Type: Interventional Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment Investigator Details Lead Sponsor: Biogen Collaborator: Elan Pharmaceuticals Study Director: Michael Panzara, MD, MPH Biogen
2 Principal Investigator: Richard A Rudick, MD The Cleveland Clinic Trial Location Details Facility: University of Alabama-Birmingham, Department of Neurology Birmingham, United States Facility: Phoenix Neurological Associates, Ltd. Phoenix, United States Facility: University of Arkansas For Medical Sciences Little Rock, United States Facility: University of California - Irvine Irvine, United States Facility: USC MS Comprehensive Care Center Los Angeles, United States Facility: Kaiser-Permanente Medical Center Redwood City, United States Facility: MS Center at UCSF San Francisco, United States Facility: Healthsouth Rehabilitation Hospital Colorado Springs, United States Facility: University of Colorado MS Center Denver, United States Facility: Griffin Hospital Derby, United States Facility: Georgetown Univesity Hospital, Research Pharmacy Washington, United States Facility: George Washington University MS Center Washington, United States Facility: North Ridge NeuroScience Center Ft. Lauderdale, United States Facility: Maitland Neurology Maitland, United States Facility: University of Miami, Department of Neurology Miami, United States Facility: The Multiple Sclerosis Center of Atlanta Atlanta, United States Facility: Marietta Neurological Associates Marietta, United States Facility: Northwestern University, Department of Neurology Chicago, United States Facility: Rush-Presbyterian St. Luke's Medical Center Chicago, United States Facility: Alexian Brothers Center for Clinical Research Elk Grove Village, United States Facility: Loyola Medical Center Maywood, United States Facility: Consultants in Neurology Northbrook Northbrook, United States Facility: Springfield Clinic Neuroscience Institute Springfield, United States Facility: Indiana University Medical Center Indianapolis, United States
3 Facility: Mercy Hospital Outpatient Pharmacy Des Moines, United States Facility: LSU Neurolgoy Clinic in New Orleans New Orleans, United States Facility: Maine Neurology Scarborough, United States Facility: University of Maryland Hospital, Department of Neurology Baltimore, United States Facility: Brigham and Women's Hospital Boston, United States Facility: University of Massachusetts Memorial Medical Center Worcester, United States Facility: Henry Ford Hospital Detroit, United States Facility: Michigan State University MS Clinic East Lansing, United States Facility: Michigan Institute for Neurological Disorders Farmington Hills, United States Facility: Noran Neurological Clinic Minneapolis, United States Facility: University of Mississippi Medical Center Jackson, United States Facility: St. John's Mercy Medical Center St. Louis, United States Facility: Bernard W. Gimbel MS Center Teaneck, United States Facility: Upstate Clinical Research, LLC Albany, United States Facility: Albany Medical Center Albany, United States Facility: Maimonides Medical Center, Division of Neurology Brooklyn, United States Facility: Buffalo General Hospital, Department of Neurology Buffalo, United States Facility: MS Care Center New York, United States Facility: St. Luke's Roosevelt Hospital, MS Research & Treatment Center New York, United States Facility: New York Hospital - Cornell Medical Center New York, United States Facility: New York State Psychiatric Institution New York, United States Facility: Strong Health Pharmacy Services Rochester, United States Facility: Staten Island University Hospital Staten Island, United States Facility: University Hospital at Stony Brook Stony Brook, United States Facility: SUNY Upstate Medical University Syracuse, United States Facility: MS Center at Carolinas Medical Center Charlotte, United States Facility: Raleigh Neurology Associates Raleigh, United States Facility: Wake Forest University School of Medicine, Department of Neurology Winston-Salem, United States
4 Facility: Riverhills Neurology Cincinnati, United States Facility: Cleveland Clinic Foundation Cleveland, United States Facility: Providence Saint Vincent Medical Center Portland, United States Facility: Geisinger Medical Center Danville, United States Facility: Hospital of the University of Pennsylvania Philadelphia, United States Facility: Greenstein Neurology Associates & MS Institute Philadelphia, United States Facility: Allegheny Singer Research Institute Pittsburgh, United States Facility: University of Pittsburgh, Department of Neurology Pittsburgh, United States Facility: University of Tennessee - Memphis Memphis, United States Facility: Vanderbilt Medical Center Nashville, United States Facility: Option Care Infusion Dallas, United States Facility: UTSW Medical School Dallas, United States Facility: Baylor Methodist International MS Center Houston, United States Facility: Central Texas Neurology Round Rock, United States Facility: Fletcher Allen Health Care Burlington, United States Facility: University of Virginia Health Sciences Charlottesville, United States Facility: Neurological Associates, Inc. Richmond, United States Facility: Virginia Mason Medical Center Seattle, United States Facility: MS Research Center Seattle, United States Facility: St. Francis Hospital, Center for Neurological Disorders Milwaukee, United States Facility: Universitatsklinik fur Neurologie Graz, Austria Facility: Universitatsklinik fur Neurologie Innsbruck, Austria Facility: Hopital Universitaire U.L.B. Erasme Brussels, Belgium Facility: Elisabeth Ziekenhuis Sijsele, Belgium Facility: Hopital Pellegrin Tripode, Neurologie Bordeaux, France Facility: Hopital neurologique Pierre Werth Lyon, France Facility: Judisches Krankenhaus Berlin, Germany Facility: Universitaetsklinikum Giessen, Oberarzt Neurologie Giessen, Germany Facility: Medizinische Hochschule Hannover, Neurologische Klinik Hannover, Germany
5 Facility: Neurologische Abteilung Henningsdorf, Germany Facility: Städtische Kliniken Osnabrück Osnabrück, Germany Facility: Asklepios Klinik Schildautal Seesen/Harz, Germany Facility: Fachbereich Neurologie und Klinische Neurophysiologie Wiesbaden, Germany Facility: Hadassah Hebrew Uni Hospital, Department of Neurology Jerusalem, Israel Facility: Sheba Medical Center, MS Center Tel Hashomer, Israel Facility: Universita di Genova, Clinica Neurologica Genova, Italy Interventions Drug: Natalizumab Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks. Drug: Placebo Placebo monthly infusion for up to 116 weeks. Published Research Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med Mar 2;354(9): Information Source ID Number: C-1802 NCT Identifier: NCT Health Authority: United States: Food and Drug Administration Full Source of Clinical Trial Data: ClinicalTrials.gov processed this data on June 30, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.
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