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| Name | Class |
|---|---|
| Elan Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Natalizumab 300 mg, IV |
|
| Group 2 | Placebo Comparator | Placebo IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks. |
|
| Measure | Description | 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. | 1 year and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in MRI changes and clinical relapses | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Panzara, MD, MPH | Biogen | Study Director |
| Chris Polman, MD | VU Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259 | United States | ||
| East Bay Region Associates in Neurology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25511792 | Background | Voloshyna N, Havrdova E, Hutchinson M, Nehrych T, You X, Belachew S, Hotermans C, Paes D. Natalizumab improves ambulation in relapsing-remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM. Eur J Neurol. 2015 Mar;22(3):570-7. doi: 10.1111/ene.12618. Epub 2014 Dec 15. | |
| 16510744 |
| Label | URL |
|---|---|
| The web site of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families and healthcare providers | View source |
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| Placebo | Drug | Placebo, IV infusion, every 4 weeks, for up to 116 weeks. |
|
| Berkeley |
| California |
| 94705 |
| United States |
| UC Davis School of Medicine, Department of Neurology | Davis | California | 95817-2307 | United States |
| Yale University School of Medicine, Department of Neurology | New Haven | Connecticut | 06510 | United States |
| University of Miami School of Medicine, Department of Neurology | Miami | Florida | 33136 | United States |
| University of Kansas Medical Center, Department of Neurology | Kansas City | Kansas | 66160 | United States |
| Michigan Institute for Neurological Disorders | Farmington Hills | Michigan | 48335 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Gimbel MS Center | Teaneck | New Jersey | 07666 | United States |
| CMRRC | Albuquerque | New Mexico | 87131 | United States |
| Oregon Health Sciences University, Department of Neurology | Portland | Oregon | 97201-3098 | United States |
| Lehigh Valley Hospital, Neurosciences Research | Allentown | Pennsylvania | 18103 | United States |
| Texas Neurology | Dallas | Texas | 75214 | United States |
| University of Washington MS Research Center | Seattle | Washington | 98195 | United States |
| Algemeen Ziekenhuis St. Jan | Bruges | 8000 | Belgium |
| LUC- University Centre | Diepenbeek | 3590 | Belgium |
| National MS Centrum | Melsbroek | 1820 | Belgium |
| Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group | Vancouver | British Columbia | V6T 2B5 | Canada |
| Health Services Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Kingston General Hospital, Neurology | Kingston | Ontario | K7L 2V7 | Canada |
| University Hospital | London | Ontario | N6A 5A5 | Canada |
| Sunnybrook and Women's College and Health Science Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University of Toronto, MS Clinic, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| CHVO Hull Hospital | Québec | Quebec | J8Y 1W7 | Canada |
| MS Research Unit, Center for Clinical Research | Halifax | B3H 1V7 | Canada |
| Family Medical Centre | Ottawa | K1N 5C7 | Canada |
| Faculty Hospital Brno Bohunice | Brno | 60200 | Czechia |
| Faculty Hospital St. Anne | Brno | 656 91 | Czechia |
| Faculty Hospital of Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Faculty Hospital Olomouc | Olomouc | 775 20 | Czechia |
| Faculty Hospital Of Ostrava Poruba | Ostrava | 70852 | Czechia |
| Hospital Pardubice - Department of Neurology | Pardubice | 532 03 | Czechia |
| Faculty Hospital Plzen - Clinic of Neurology | Pilsen | 304 60 | Czechia |
| General Teaching Hospital - Neurological Department | Prague | 2 12802 | Czechia |
| Faculty Hospital Motol - Neurological Clinic | Prague | 5 105 06 | Czechia |
| Hopital de la Timone, Service de Neurologie | Marseille | 13385 | France |
| CHRU - Hopital de Pontchaillou, Service de Neurologie | Rennes | 35033 | France |
| St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum | Bochurn | 44791 | Germany |
| Klinika Neurologii | Bydgoszcz | 85-681 | Germany |
| Academisch Ziekenhuis VU | Amsterdam | 1081 HV | Netherlands |
| Institute of Neurology | Queen Square | London | WC1N 3BG | United Kingdom |
| The Royal London Hospital | Whitechapel | London | E1 1BB | United Kingdom |
| Atkin's Morely Hospital | Wimbledon | London | SW20 0NE | United Kingdom |
| Oldchurch Hospital | Essex | NE1 4LP | United Kingdom |
| Ipswich Hospital NHS Trust - Department of Clinical Neurology | Ipswich | IP4 5PD | United Kingdom |
| St. James University Hospital, Department of Neurology | Leeds | LS9 7TF | United Kingdom |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Kings College Hospital, Kings Neuroscience Center | London | SE5 9RS | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| The Radcliffe Infirmary, University Department of Clinical Neurology | Oxford | OX2 0HE | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| North Staffordshire Royal Infirmary - Neurology Department | Stoke-on-Trent | ST4 7LN | United Kingdom |
| Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. doi: 10.1056/NEJMoa044397. |
| 38469809 | Derived | Nakamura K, Sun Z, Hara-Cleaver C, Bodhinathan K, Avila RL. Natalizumab reduces loss of gray matter and thalamic volume in patients with relapsing-remitting multiple sclerosis: A post hoc analysis from the randomized, placebo-controlled AFFIRM trial. Mult Scler. 2024 May;30(6):687-695. doi: 10.1177/13524585241235055. Epub 2024 Mar 12. |
| 37173129 | Derived | Strijbis EM, Coerver E, Mostert J, van Kempen ZLE, Killestein J, Comtois J, Repovic P, Bowen JD, Cutter G, Koch M. Association of age and inflammatory disease activity in the pivotal natalizumab clinical trials in relapsing-remitting multiple sclerosis. J Neurol Neurosurg Psychiatry. 2023 Oct;94(10):792-799. doi: 10.1136/jnnp-2022-330887. Epub 2023 May 12. |
| 22521274 | Derived | Balcer LJ, Galetta SL, Polman CH, Eggenberger E, Calabresi PA, Zhang A, Scanlon JV, Hyde R. Low-contrast acuity measures visual improvement in phase 3 trial of natalizumab in relapsing MS. J Neurol Sci. 2012 Jul 15;318(1-2):119-24. doi: 10.1016/j.jns.2012.03.009. Epub 2012 Apr 21. |
| MSActiveSource.com is a resource for news, information and disease management for all individuals touched by multiple sclerosis. This site is sponsored by Biogen. | View source |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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