A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
NCT ID: NCT00642902
Last Updated: 2016-05-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
255 participants
INTERVENTIONAL
2008-04-30
2009-09-30
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
QUADRUPLE
Study Groups
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Atacicept 25 mg
Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Atacicept 75 mg
Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Atacicept 150 mg
Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Placebo
Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Interventions
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Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
Eligibility Criteria
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Exclusion Criteria
* Have secondary progressive MS without superimposed relapses
* Relevant cardiac, hepatic and renal diseases as specified in the protocol
* Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
18 Years
60 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
Locations
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Research Site
Phoenix, Arizona, United States
Research Site
Atlanta, Georgia, United States
Research Site
Northbrook, Illinois, United States
Research Site
East Lansing, Michigan, United States
Research Site
Jefferson, New Hampshire, United States
Research Site
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Research Site
Nashville, Tennessee, United States
Research Site
Box Hill, , Australia
Research Site
Fitzroy, , Australia
Research Site
New Lambton, , Australia
Research Site
Woodville, , Australia
Research Site
Innsbruck, , Austria
Research Site
Diepenbeek, , Belgium
Research Site
Sijsele, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Ontario, , Canada
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Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Caen, , France
Research Site
Saint-Herblain, , France
Research Site
Bochum, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Beirut, , Lebanon
Research Site
Kaunas, , Lithuania
Research Site
Breda, , Netherlands
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Nieuwegein, , Netherlands
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Rotterdam, , Netherlands
Research Site
Dnipropetrovsk, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
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Saint Petersburg, , Russia
Research Site
Samara, , Russia
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Vladimir, , Russia
Research Site
Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Stockholm, , Sweden
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Basel, , Switzerland
Research Site
Kharkiv, , Ukraine
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Kyiv, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
London, , United Kingdom
Research Site
Sheffield, , United Kingdom
Research Site
Stoke-on-Trent, , United Kingdom
Countries
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References
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Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.
Related Links
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Related Info
Other Identifiers
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28063
Identifier Type: -
Identifier Source: org_study_id
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