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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206648

Acronym

ABOVE

Enrollment

271

Registered

2005-09-21

Start date

2003-03-31

Completion date

2005-10-31

Last updated

2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

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.

Interventions

DRUGBetaferon/Betaseron

Betaseron 250 µg SC every other day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Primary Progressive or Secondary Progressive MS

Design outcomes

Primary

Measure	Time frame
Time to onset of first relapse	Time to onset of first relapse

Secondary

Measure	Time frame
Number of patients relapse free at week 104	At week 104

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026