Atacicept in Multiple Sclerosis Extension Study, Phase II
Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063
(NCT00642902). The aim of this study 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 subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive
atacicept at 150 mg once a week subcutaneously 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
initial and part A treatment allocation/dose.