Bayer HealthCare

BEYOND: Betaferon/Betaseron efficacy yielding outcomes of a new dose in Multiple Sclerosis (MS) Patients

Trial ID:

91162

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

Indication/Disease:

Multiple Sclerosis, Relapsing-Remitting

Status:

Completed
Trial Start Date:2003-11-18

Phase:

Phase III

Trial Type:

Interventional
Purpose:Treatment, Allocation: Randomized, Masking: Double Blind, Control: Dose Comparison, Assignment: Parallel Assignment, Number of arms:3, Number of participants: 2244

Trial Purpose:

Safety/Efficacy Study

Product:

Betaseron (Interferon beta-1b, BAY86-5046)

Intervention Type:

Drug

Sponsor:

Bayer Schering Pharma AG

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.

Countries:

Argentina	Completed
Australia	Completed
Austria	Completed
Belgium	Completed
Brazil	Completed
Canada	Completed
Denmark	Completed
Finland	Completed
France	Completed
Germany	Completed
Greece	Completed
Hungary	Completed
Ireland	Completed
Israel	Completed
Italy	Completed
Latvia	Completed
Netherlands	Completed
Norway	Completed
Poland	Completed
Russia	Completed
Slovenia	Completed
Spain	Completed
Sweden	Completed
Switzerland	Completed
Ukraine	Completed
United States	Completed

Key Eligibility
Criteria:

Healthy Volunteers: No
Gender :Both
Minimum Age :18 Years
Maximum Age :55 Years

Other inclusion / exclusion criteria may apply.

Primary outcomes:

Hazard ratio for relapses
Time Frame: During the first and during the second 52 weeks

Secondary outcomes:

Time to confirmed Expanded Disability Status Score (EDSS) progression
Time Frame: After 52 and after 104 weeks
Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
Time Frame: After 104 weeks