NCT01864148

Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BIIB033
OTHER	Placebo
DRUG	Avonex

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2013-05-29
• Last updated: 2017-05-03
• Results posted: 2017-05-03

Locations

72 sites across 12 countries: United States, Canada, Czechia, France, Hungary, Italy, Netherlands, Poland, Russia, Serbia, Spain, United Kingdom