Long-Term Safety and Efficacy Study of Peginterferon Beta-1a



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 70
Updated:8/11/2016
Start Date:April 2011
End Date:October 2015

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A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

The primary objective of this study is to evaluate the long-term safety and tolerability of
peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301
(NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this
study is to describe long-term multiple sclerosis (MS) outcomes in participants originally
treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.


Key Inclusion Criteria:

- Must have completed the study treatment and visit schedule through Week 96 in Study
105MS301 (NCT00906399).

Key Exclusion Criteria:

- Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study
105MS301 (NCT00906399).

- Subjects with any clinically significant lab abnormalities, malignancies, cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,
neurologic, dermatologic, psychiatric, renal, or other major disease

- Pregnant or nursing women.

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