Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
1094 participants
INTERVENTIONAL
2006-03-31
2014-04-30
Brief Summary
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Detailed Description
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The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 \[NCT00306592\] record.)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
Natalizumab
Interventions
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Natalizumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study.
* In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).
Exclusion Criteria
* History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
* History of any major disease or malignancy
* Discontinued natalizumab in a previous study due to allergic reaction
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Camperdown, , Australia
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Heidelberg, , Australia
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Parkville, , Australia
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Bruges, , Belgium
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Brussels, , Belgium
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Charleroi, , Belgium
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Diepenbeek, , Belgium
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Melsbroek, , Belgium
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Sijsele, , Belgium
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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New York, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Aarhus C, , Denmark
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Copenhagen, , Denmark
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Esbjerg, , Denmark
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Besançon, , France
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Bordeaux, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Dijon, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Nancy, , France
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Paris, , France
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Paris, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Essen, , Germany
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Giessen, , Germany
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Hanover, , Germany
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Hennigsdorf, , Germany
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München, , Germany
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Offenbach, , Germany
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Osnabrück, , Germany
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Regensburg, , Germany
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Rostock, , Germany
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Athens, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Nyíregyháza, , Hungary
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Székesfehérvár, , Hungary
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Dublin, , Ireland
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Jerusalem, , Israel
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Tel Litwinsky, , Israel
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Bari, , Italy
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Genova, , Italy
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Milan, , Italy
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Roma, , Italy
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Nieuwegein, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Bialystok, , Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Barcelona, , Spain
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Barcelona, , Spain
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Málaga, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Stockholm, , Sweden
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Basel, , Switzerland
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Essex, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303. doi: 10.1002/ana.22128.
Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray SS, Griffith NM, Jurgensen SA, Gorelik L, Forrestal F, Sandrock AW, Goelz SE. Assessment of JC virus DNA in blood and urine from natalizumab-treated patients. Ann Neurol. 2010 Sep;68(3):304-10. doi: 10.1002/ana.22107.
O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4.
Related Links
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The website 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 Idec.
Other Identifiers
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101-MS-321
Identifier Type: -
Identifier Source: org_study_id
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