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

Phase 4

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: Betaferon/Betaseron

• Registration Number: NCT00206648
• Lead Sponsor: Bayer

Brief 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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2005-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• RRMS patients that are receiving treatment with Avonex 30 µg once weekly

Exclusion Criteria

• Primary Progressive or Secondary Progressive MS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Betaferon/Betaseron	-
Arm 2	Betaferon/Betaseron	-

Primary Outcome Measures

Name	Time	Method
Time to onset of first relapse	Time to onset of first relapse

Secondary Outcome Measures

Name	Time	Method
Number of patients relapse free at week 104	At week 104