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

Study Overview
=================
Brief 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.

Official Title
-----------------
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.

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
* Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
* Drug: Copaxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients Aged 18-55 years Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0 Treatment-naive to IFNB or Copaxone Exclusion Criteria: Neurological progression at disease onset or between relapses Serious or acute heart diseases History of severe depression or suicide attempt Serious or acute liver, renal or bone marrow dysfunction Monoclonal gammopathy Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 250mcg administered s.c. every other day<br>|
| Experimental: Arm 2<br> | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)<br>* 500mcg administered s.c. every other day<br>|
| Active Comparator: Arm 3<br> | Drug: Copaxone<br>* 20 mg administered s.c. once daily.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hazard ratio for relapses |  | During the first and during the second 52 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron