An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-Remitting MS (ABOVE)
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.
Multiple Sclerosis, Relapsing-Remitting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Time to onset of first relapse [ Time Frame: Time to onset of first relapse ] [ Designated as safety issue: No ]
- Number of patients relapse free at week 104 [ Time Frame: At week 104 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Study Completion Date:||October 2005|
|Experimental: Arm 1||
Betaseron 250 µg SC every other day
|Active Comparator: Arm 2||
Avonex 30 µg IM once per week
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.
Show 53 Study Locations
|Study Director:||Bayer Study Director||Bayer|