Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis
NCT ID: NCT00027300
Last Updated: 2017-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
900 participants
INTERVENTIONAL
2001-11-30
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1
Natalizumab 300 mg, IV
Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Group 2
Placebo IV infusion
Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
Interventions
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Natalizumab
Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.
Placebo
Placebo, IV infusion, every 4 weeks, for up to 116 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 18 and 50, inclusive.
* Baseline EDSS score between 0.0 and 5.0, inclusive.
* Have experienced at least one relapse within the 12 months prior to randomization.
* Cranial MRI scan demonstrating lesion(s) consistent with MS.
* Have given written informed consent to participate in the study.
Exclusion Criteria
* MS relapse has occurred,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
* A clinically significant infectious illness within 30 days prior to randomization.
* History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent 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 performed at the Screening Visit.
18 Years
50 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Principal Investigators
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Michael Panzara, MD, MPH
Role: STUDY_DIRECTOR
Biogen
Chris Polman, MD
Role: PRINCIPAL_INVESTIGATOR
VU Medical Centre
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
East Bay Region Associates in Neurology
Berkeley, California, United States
UC Davis School of Medicine, Department of Neurology
Davis, California, United States
Yale University School of Medicine, Department of Neurology
New Haven, Connecticut, United States
University of Miami School of Medicine, Department of Neurology
Miami, Florida, United States
University of Kansas Medical Center, Department of Neurology
Kansas City, Kansas, United States
Michigan Institute for Neurological Disorders
Farmington Hills, Michigan, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Gimbel MS Center
Teaneck, New Jersey, United States
CMRRC
Albuquerque, New Mexico, United States
Oregon Health Sciences University, Department of Neurology
Portland, Oregon, United States
Lehigh Valley Hospital, Neurosciences Research
Allentown, Pennsylvania, United States
Texas Neurology
Dallas, Texas, United States
University of Washington MS Research Center
Seattle, Washington, United States
Algemeen Ziekenhuis St. Jan
Bruges, , Belgium
LUC- University Centre
Diepenbeek, , Belgium
National MS Centrum
Melsbroek, , Belgium
Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group
Vancouver, British Columbia, Canada
Health Services Centre
Winnipeg, Manitoba, Canada
Kingston General Hospital, Neurology
Kingston, Ontario, Canada
University Hospital
London, Ontario, Canada
Sunnybrook and Women's College and Health Science Centre
Toronto, Ontario, Canada
University of Toronto, MS Clinic, St. Michael's Hospital
Toronto, Ontario, Canada
CHVO Hull Hospital
Québec, Quebec, Canada
MS Research Unit, Center for Clinical Research
Halifax, , Canada
Family Medical Centre
Ottawa, , Canada
Faculty Hospital Brno Bohunice
Brno, , Czechia
Faculty Hospital St. Anne
Brno, , Czechia
Faculty Hospital of Hradec Kralove
Hradec Králové, , Czechia
Faculty Hospital Olomouc
Olomouc, , Czechia
Faculty Hospital Of Ostrava Poruba
Ostrava, , Czechia
Hospital Pardubice - Department of Neurology
Pardubice, , Czechia
Faculty Hospital Plzen - Clinic of Neurology
Pilsen, , Czechia
General Teaching Hospital - Neurological Department
Prague, , Czechia
Faculty Hospital Motol - Neurological Clinic
Prague, , Czechia
Hopital de la Timone, Service de Neurologie
Marseille, , France
CHRU - Hopital de Pontchaillou, Service de Neurologie
Rennes, , France
St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum
Bochurn, , Germany
Klinika Neurologii
Bydgoszcz, , Germany
Academisch Ziekenhuis VU
Amsterdam, , Netherlands
Institute of Neurology
Queen Square, London, United Kingdom
The Royal London Hospital
Whitechapel, London, United Kingdom
Atkin's Morely Hospital
Wimbledon, London, United Kingdom
Oldchurch Hospital
Essex, , United Kingdom
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich, , United Kingdom
St. James University Hospital, Department of Neurology
Leeds, , United Kingdom
Guy's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Kings College Hospital, Kings Neuroscience Center
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
The Radcliffe Infirmary, University Department of Clinical Neurology
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
North Staffordshire Royal Infirmary - Neurology Department
Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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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.
Other Identifiers
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C-1801
Identifier Type: -
Identifier Source: org_study_id
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