NCT00206648

An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS

A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.

Detailed description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Betaferon/Betaseron	Betaseron 250 µg SC every other day
DRUG	Betaferon/Betaseron	Avonex 30 µg IM once per week

Timeline

• Start date: 2003-03-01
• Completion: 2005-10-01
• First posted: 2005-09-21
• Last updated: 2014-12-31

Locations

53 sites across 2 countries: United States, Canada