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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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2010-03-31
2011-11-30
Brief Summary
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The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:
* when MS symptoms return, and
* if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.
This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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natalizumab
natalizumab
300 mg intravenous every 4 weeks
IV placebo
IV placebo
placebo intravenous every 4 weeks
interferon β-1a, glatiramer acetate, or methylprednisolone
interferon beta 1-a
30 ug intramuscular once per week
methylprednisolone
1000 mg intravenous every 4 weeks
glatiramer acetate
20 mg subcutaneous once daily
Interventions
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natalizumab
300 mg intravenous every 4 weeks
interferon beta 1-a
30 ug intramuscular once per week
methylprednisolone
1000 mg intravenous every 4 weeks
IV placebo
placebo intravenous every 4 weeks
glatiramer acetate
20 mg subcutaneous once daily
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of a relapsing form of MS
* Treatment with natalizumab according to locally approved prescribing information
* Other protocol defined inclusion/exclusion criteria may apply
18 Years
60 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Locations
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Research Site
Cullman, Alabama, United States
Research Site
San Francisco, California, United States
Research Site
Fort Collins, Colorado, United States
Research Site
Pompano Beach, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Atlanta, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Lake Barrington, Illinois, United States
Research Site
Des Moines, Iowa, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Buffalo, New York, United States
Research Site
Latham, New York, United States
Research Site
Patchogue, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Uniontown, Ohio, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Seattle, Washington, United States
Research Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Research Site
München, Bavaria, Germany
Research Site
Hennigsdorf, Brandenburg, Germany
Research Site
Hamburg, City state of Hamburg, Germany
Research Site
Marburg, Hesse, Germany
Research Site
Bochum, North Rhine-Westphalia, Germany
Research Site
Dresden, Saxony, Germany
Research Site
Barcelona, Barcelona, Spain
Research Site
L'Hospitalet de Llobregat, Barcelona, Spain
Research Site
Málaga, Malaga, Spain
Research Site
El Palmar, Murcia, Spain
Research Site
Valencia, Valencia, Spain
Research Site
Valencia, Valencia, Spain
Countries
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References
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Fox RJ, Cree BAC, de Seze J, Gold R, Hartung HP, Jeffery D, Kappos L, Montalban X, Weinstock-Guttman B, Singh CM, Altincatal A, Belviso N, Avila RL, Ho PR, Su R, Engle R, Sangurdekar D, de Moor C, Fisher E, Kieseier BC, Rudick RA. Temporal Relationship Between Serum Neurofilament Light Chain and Radiologic Disease Activity in Patients With Multiple Sclerosis. Neurology. 2024 May 14;102(9):e209357. doi: 10.1212/WNL.0000000000209357. Epub 2024 Apr 22.
Nakamura K, Brown RA, Narayanan S, Collins DL, Arnold DL; Alzheimer's Disease Neuroimaging Initiative. Diurnal fluctuations in brain volume: Statistical analyses of MRI from large populations. Neuroimage. 2015 Sep;118:126-32. doi: 10.1016/j.neuroimage.2015.05.077. Epub 2015 Jun 3.
Other Identifiers
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101MS205
Identifier Type: -
Identifier Source: org_study_id