NCT01332019

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,077 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	peginterferon beta-1a	Administered as specified in the treatment arm

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-04-08
• Last updated: 2017-01-13
• Results posted: 2017-01-13

Locations

151 sites across 26 countries: United States, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom