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 |
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.
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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