Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in
 reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis
 (RMS) at 1 year. The secondary objectives of this study are to determine whether
 peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the
 total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance
 imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the
 progression of disability.
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled
 study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to
 Week 48) is referred to as the placebo-controlled treatment period of the study. At the
 beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon
 beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of
 Treatment Year 1, participants in the placebo group were re-randomized to receive
 peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all
 participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol,
 all primary and secondary endpoints pertain to Year 1 data.
Key Inclusion Criteria:

 -  Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by
 McDonald criteria 1 through 4 (Polman, 2005)

 -  Must have an EDSS score between 0.0 and 5.0.

 -  Must have experienced at least 2 relapses that have been medically documented within
 the last 3 years with at least one occurring in the last 12 months

 Key Exclusion Criteria:

 -  Other chronic disease of immune system, malignancies, urologic, pulmonary,
 gastrointestinal disease

 -  Pregnant or nursing women

 -  Prior treatment with interferon could not exceed 4 weeks and subjects must have
 discontinued interferon treatment 6 months prior to Baseline

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.