Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple Sclerosis
This study has been completed.
Sponsor:
Biogen Idec
Collaborator:
Elan Pharmaceuticals
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00030966
First received: February 15, 2002
Last updated: June 17, 2009
Last verified: June 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Natalizumab Drug: Placebo |
Phase 3 |
| 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 |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- 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. [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- If this combination reduces MRI lesions and the overall rate of clinical relapses [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 1200 |
| Study Start Date: | January 2002 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
|
Drug: Natalizumab
Natalizumab, 300 mg, monthly IV infusion for up to 116 weeks.
Other Name: Tysabri
|
|
Placebo Comparator: Group 2
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
|
Drug: Placebo
Placebo monthly infusion for up to 116 weeks.
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030966
Hide Study Locations
Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama-Birmingham, Department of Neurology | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Phoenix Neurological Associates, Ltd. | |
| Phoenix, Arizona, United States, 85008 | |
| United States, Arkansas | |
| University of Arkansas For Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| University of California - Irvine | |
| Irvine, California, United States, 92697 | |
| USC MS Comprehensive Care Center | |
| Los Angeles, California, United States, 90033 | |
| Kaiser-Permanente Medical Center | |
| Redwood City, California, United States, 94063 | |
| MS Center at UCSF | |
| San Francisco, California, United States, 94117 | |
| United States, Colorado | |
| Healthsouth Rehabilitation Hospital | |
| Colorado Springs, Colorado, United States, 80910 | |
| University of Colorado MS Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Connecticut | |
| Griffin Hospital | |
| Derby, Connecticut, United States, 06418 | |
| United States, District of Columbia | |
| Georgetown Univesity Hospital, Research Pharmacy | |
| Washington, District of Columbia, United States, 20007 | |
| George Washington University MS Center | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| North Ridge NeuroScience Center | |
| Ft. Lauderdale, Florida, United States, 33334 | |
| Maitland Neurology | |
| Maitland, Florida, United States, 32751 | |
| University of Miami, Department of Neurology | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| The Multiple Sclerosis Center of Atlanta | |
| Atlanta, Georgia, United States, 30327 | |
| Marietta Neurological Associates | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Northwestern University, Department of Neurology | |
| Chicago, Illinois, United States, 60611 | |
| Rush-Presbyterian St. Luke's Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Alexian Brothers Center for Clinical Research | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Loyola Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Consultants in Neurology Northbrook | |
| Northbrook, Illinois, United States, 60062 | |
| Springfield Clinic Neuroscience Institute | |
| Springfield, Illinois, United States, 62702 | |
| United States, Indiana | |
| Indiana University Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Mercy Hospital Outpatient Pharmacy | |
| Des Moines, Iowa, United States, 50314 | |
| United States, Louisiana | |
| LSU Neurolgoy Clinic in New Orleans | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maine | |
| Maine Neurology | |
| Scarborough, Maine, United States, 04074-8926 | |
| United States, Maryland | |
| University of Maryland Hospital, Department of Neurology | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655-0138 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202-2608 | |
| Michigan State University MS Clinic | |
| East Lansing, Michigan, United States, 48824 | |
| Michigan Institute for Neurological Disorders | |
| Farmington Hills, Michigan, United States, 48334 | |
| United States, Minnesota | |
| Noran Neurological Clinic | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| St. John's Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Bernard W. Gimbel MS Center | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| Upstate Clinical Research, LLC | |
| Albany, New York, United States, 12205 | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Maimonides Medical Center, Division of Neurology | |
| Brooklyn, New York, United States, 11219 | |
| Buffalo General Hospital, Department of Neurology | |
| Buffalo, New York, United States, 14203 | |
| New York Hospital - Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| New York State Psychiatric Institution | |
| New York, New York, United States, 10032 | |
| MS Care Center | |
| New York, New York, United States, 10003 | |
| St. Luke's Roosevelt Hospital, MS Research & Treatment Center | |
| New York, New York, United States, 10019 | |
| Strong Health Pharmacy Services | |
| Rochester, New York, United States, 14642 | |
| Staten Island University Hospital | |
| Staten Island, New York, United States, 10305 | |
| University Hospital at Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| MS Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Raleigh Neurology Associates | |
| Raleigh, North Carolina, United States, 27607 | |
| Wake Forest University School of Medicine, Department of Neurology | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Riverhills Neurology | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Oregon | |
| Providence Saint Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822 | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Greenstein Neurology Associates & MS Institute | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| University of Pittsburgh, Department of Neurology | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Allegheny Singer Research Institute | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| United States, Tennessee | |
| University of Tennessee - Memphis | |
| Memphis, Tennessee, United States, 38163 | |
| Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37215 | |
| United States, Texas | |
| Option Care Infusion | |
| Dallas, Texas, United States, 75226 | |
| UTSW Medical School | |
| Dallas, Texas, United States, 75235-9036 | |
| Baylor Methodist International MS Center | |
| Houston, Texas, United States, 77030 | |
| Central Texas Neurology | |
| Round Rock, Texas, United States, 78681 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Virginia | |
| University of Virginia Health Sciences | |
| Charlottesville, Virginia, United States, 22908 | |
| Neurological Associates, Inc. | |
| Richmond, Virginia, United States, 23226 | |
| United States, Washington | |
| MS Research Center | |
| Seattle, Washington, United States, 98195 | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98111 | |
| United States, Wisconsin | |
| St. Francis Hospital, Center for Neurological Disorders | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Austria | |
| Universitatsklinik fur Neurologie | |
| Graz, Austria, 8036 | |
| Universitatsklinik fur Neurologie | |
| Innsbruck, Austria, 6020 | |
| Belgium | |
| Hopital Universitaire U.L.B. Erasme | |
| Brussels, Belgium, 1780 | |
| Elisabeth Ziekenhuis | |
| Sijsele, Belgium, 8340 | |
| France | |
| Hopital Pellegrin Tripode, Neurologie | |
| Bordeaux, France, 33076 | |
| Hopital neurologique Pierre Werth | |
| Lyon, France, 69394 | |
| Germany | |
| Judisches Krankenhaus | |
| Berlin, Germany, 13347 | |
| Universitaetsklinikum Giessen, Oberarzt Neurologie | |
| Giessen, Germany, 35390 | |
| Medizinische Hochschule Hannover, Neurologische Klinik | |
| Hannover, Germany, 30625 | |
| Neurologische Abteilung | |
| Henningsdorf, Germany, 16761 | |
| Städtische Kliniken Osnabrück | |
| Osnabrück, Germany, 49076 | |
| Asklepios Klinik Schildautal | |
| Seesen/Harz, Germany, 38723 | |
| Fachbereich Neurologie und Klinische Neurophysiologie | |
| Wiesbaden, Germany, 65191 | |
| Israel | |
| Hadassah Hebrew Uni Hospital, Department of Neurology | |
| Jerusalem, Israel | |
| Sheba Medical Center, MS Center | |
| Tel Hashomer, Israel, 52621 | |
| Italy | |
| Universita di Genova, Clinica Neurologica | |
| Genova, Italy, 16132 | |
Sponsors and Collaborators
Biogen Idec
Elan Pharmaceuticals
Investigators
| Study Director: | Michael Panzara, MD, MPH | Biogen Idec |
| Principal Investigator: | Richard A Rudick, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00030966 History of Changes |
| Other Study ID Numbers: | C-1802 |
| Study First Received: | February 15, 2002 |
| Last Updated: | June 17, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biogen Idec:
|
Multiple Sclerosis MS |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Interferon beta 1a Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013