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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00642902 |
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Date of registration:
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21/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
ATAMS |
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Scientific title:
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A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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255 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00642902 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Lebanon
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Lithuania
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Netherlands
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Russian Federation
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Spain
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Sweden
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Switzerland
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Medical Responsible |
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Address:
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Telephone:
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Email:
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Affiliation:
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EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion
criteria could apply.
Exclusion Criteria:
- Have primary progressive multiple sclerosis (MS)
- 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
- Clinical significant acute or chronic infections as specified in the protocol Other
protocol-defined exclusion criteria could apply.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Multiple Sclerosis
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Intervention(s)
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Drug: Atacicept
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Drug: Placebo matched to atacicept
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Primary Outcome(s)
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Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
[Time Frame: Weeks 12 to 36]
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Secondary Outcome(s)
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
[Time Frame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug]
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Number of New T1 Gd-enhancing Lesions Per Participant
[Time Frame: Weeks 12, 24, 36]
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Percentage of Participants Free From Relapses
[Time Frame: Baseline up to Week 36]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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