Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2008-06-30
2011-01-31
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
QUADRUPLE
Study Groups
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Atacicept
Atacicept
Atacicept will be administered subcutaneously at a dose of 150 milligram (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 150 milligram (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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Inclusion Criteria
Exclusion Criteria
* Relevant cardiac, hepatic and renal diseases
* Clinical significant abnormalities in blood cell counts and immunoglobulin levels
* Clinical significant acute or chronic infections
18 Years
60 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
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 MerckKGaA, Darmstadt, Germany
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Aurora, Colorado, United States
Research Site
Fairfield, Connecticut, United States
Research Site
Jacksonville, Florida, United States
Research Site
East Lansing, Michigan, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Parkville, Victoria, Australia
Research Site
Brussels, , Belgium
Research Site
Vancouver, British Columbia, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Hradec Králové, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Paris, , France
Research Site
Freiburg im Breisgau, , Germany
Research Site
Munich, , Germany
Research Site
Tübingen, , Germany
Research Site
Würzburg, , Germany
Research Site
Beirut, , Lebanon
Research Site
Dbaïyé, , Lebanon
Research Site
Barcelona, , Spain
Research Site
Seville, , Spain
Research Site
Valencia, , Spain
Research Site
Lausanne, , Switzerland
Research Site
London, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
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Other Identifiers
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28156
Identifier Type: -
Identifier Source: org_study_id
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