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| Sponsor: | Biogen Idec |
|---|---|
| Collaborator: |
Elan Pharmaceuticals |
| Information provided by: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00027300 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Natalizumab Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Enrollment: | 900 |
| Study Start Date: | November 2001 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
Natalizumab 300 mg, IV
|
Drug: Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
|
|
Group 2: Placebo Comparator
Placebo IV infusion
|
Drug: Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| East Bay Region Associates in Neurology | |
| Berkeley, California, United States, 94705 | |
| UC Davis School of Medicine, Department of Neurology | |
| Davis, California, United States, 95817-2307 | |
| United States, Connecticut | |
| Yale University School of Medicine, Department of Neurology | |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| University of Miami School of Medicine, Department of Neurology | |
| Miami, Florida, United States, 33136 | |
| United States, Kansas | |
| University of Kansas Medical Center, Department of Neurology | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Michigan | |
| Michigan Institute for Neurological Disorders | |
| Farmington Hills, Michigan, United States, 48335 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Gimbel MS Center | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New Mexico | |
| CMRRC | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Oregon | |
| Oregon Health Sciences University, Department of Neurology | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital, Neurosciences Research | |
| Allentown, Pennsylvania, United States, 18103 | |
| United States, Texas | |
| Texas Neurology | |
| Dallas, Texas, United States, 75214 | |
| United States, Washington | |
| University of Washington MS Research Center | |
| Seattle, Washington, United States, 98195 | |
| Belgium | |
| Algemeen Ziekenhuis St. Jan | |
| Brugge, Belgium, 8000 | |
| National MS Centrum | |
| Melsbroek, Belgium, 1820 | |
| LUC- University Centre | |
| Diepenbeek, Belgium, 3590 | |
| Canada | |
| Family Medical Centre | |
| Ottawa, Canada, K1N 5C7 | |
| MS Research Unit, Center for Clinical Research | |
| Halifax, Canada, B3H 1V7 | |
| Canada, British Columbia | |
| Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Canada, Manitoba | |
| Health Services Centre | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Canada, Ontario | |
| Kingston General Hospital, Neurology | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| University of Toronto, MS Clinic, St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| University Hospital | |
| London, Ontario, Canada, N6A 5A5 | |
| Sunnybrook and Women's College and Health Science Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| CHVO Hull Hospital | |
| Quebec City, Quebec, Canada, J8Y 1W7 | |
| Czech Republic | |
| Faculty Hospital Plzen - Clinic of Neurology | |
| Plzen, Czech Republic, 304 60 | |
| Hospital Pardubice - Department of Neurology | |
| Pardubice, Czech Republic, 532 03 | |
| General Teaching Hospital - Neurological Department | |
| Prague, Czech Republic, 2 12802 | |
| Faculty Hospital Motol - Neurological Clinic | |
| Prague, Czech Republic, 5 105 06 | |
| Faculty Hospital Brno Bohunice | |
| Brno, Czech Republic, 60200 | |
| Faculty Hospital St. Anne | |
| Brno, Czech Republic, 656 91 | |
| Faculty Hospital Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| Faculty Hospital of Hradec Kralove | |
| HRADEC KRALOVE, Czech Republic, 500 05 | |
| Faculty Hospital Of Ostrava Poruba | |
| Ostrava, Czech Republic, 70852 | |
| France | |
| CHRU - Hopital de Pontchaillou, Service de Neurologie | |
| Rennes, France, 35033 | |
| Hopital de la Timone, Service de Neurologie | |
| Marseille, France, 13385 | |
| Germany | |
| St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum | |
| Bochurn, Germany, 44791 | |
| Klinika Neurologii | |
| Bydgoszcz, Germany, 85-681 | |
| Netherlands | |
| Academisch Ziekenhuis VU | |
| Amsterdam, Netherlands, 1081 HV | |
| United Kingdom | |
| Guy's Hospital | |
| London, United Kingdom, SE1 9RT | |
| St. James University Hospital, Department of Neurology | |
| Leeds, United Kingdom, LS9 7TF | |
| The Radcliffe Infirmary, University Department of Clinical Neurology | |
| Oxford, United Kingdom, OX2 0HE | |
| Kings College Hospital, Kings Neuroscience Center | |
| London, United Kingdom, SE5 9RS | |
| North Staffordshire Royal Infirmary - Neurology Department | |
| Stoke on Trent, United Kingdom, ST4 7LN | |
| Oldchurch Hospital | |
| Essex, United Kingdom, NE1 4LP | |
| Royal Victoria Infirmary | |
| Newcastle upon Tyne, United Kingdom, NE1 4LP | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom, S10 2JF | |
| King's College Hospital | |
| London, United Kingdom, SE5 9RS | |
| Ipswich Hospital NHS Trust - Department of Clinical Neurology | |
| Ipswich, United Kingdom, IP4 5PD | |
| United Kingdom, London | |
| Atkin's Morely Hospital | |
| Wimbledon, London, United Kingdom, SW20 0NE | |
| Institute of Neurology | |
| Queen Square, London, United Kingdom, WC1N 3BG | |
| The Royal London Hospital | |
| Whitechapel, London, United Kingdom, E1 1BB | |
| Study Director: | Michael Panzara, MD, MPH | Biogen Idec |
| Principal Investigator: | Chris Polman, MD | VU Medical Centre |
More Information
| Responsible Party: | Biogen Idec ( Biogen Idec Medical Director ) |
| Study ID Numbers: | C-1801 |
| Study First Received: | November 30, 2001 |
| Last Updated: | June 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00027300 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Relapsing Remitting Multiple Sclerosis |
|
Pathologic Processes Autoimmune Diseases Multiple Sclerosis Immune System Diseases Demyelinating Diseases |
Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System |