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Clinical Trial Summary

This study, 28851, is a long-term follow-up study of subjects enrolled in ATAMS study 28063, the aim of which is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).

This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week sub cutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week sub cutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to intial and part A treatment allocation/dose.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00853762
Study type Interventional
Source EMD Serono
Contact
Status Terminated
Phase Phase 2
Start date February 2009
Completion date February 2011

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