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

Bayer

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Betaferon/Betaseron

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206648

307245

91293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 271 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Primary Progressive or Secondary Progressive MS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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271 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Betaferon/Betaseron

Drug: Betaferon/Betaseron

Arm 2

Active Comparator group

Treatment:

Drug: Betaferon/Betaseron

Drug: Betaferon/Betaseron