NCT00099502

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients

International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,244 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine * whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms * whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Detailed description

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	250mcg administered s.c. every other day
DRUG	Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)	500mcg administered s.c. every other day
DRUG	Copaxone	20 mg administered s.c. once daily.

Timeline

• Start date: 2003-11-01
• Completion: 2007-08-01
• First posted: 2004-12-16
• Last updated: 2008-12-19

Locations

199 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Ukraine