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

ID: NCT00099502
Status: Completed
Phase: Phase 3
Start Date: November 01, 2003
First Submitted: December 15, 2004
Last Updated: December 18, 2008
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Ukraine, United States
Conditions: Multiple Sclerosis, Relapsing-Remitting
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Study Description

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.
Condition or disease Intervention/treatment Phase

Multiple Sclerosis, Relapsing-Remitting

Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Other Names
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Other Names
Drug: Copaxone
Other Names
Phase 3

Tracking Information

First Submitted DateDecember 15, 2004
Last Update Posted DateDecember 18, 2008
Start DateNovember 01, 2003
Actual Completion DateAugust 01, 2007
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleBEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Official TitleInternational, 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.
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.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
2244
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Treatment
Conditions
Multiple Sclerosis, Relapsing-Remitting
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

250mcg administered s.c. every other day

Other Names
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)

500mcg administered s.c. every other day

Other Names
Drug: Copaxone

20 mg administered s.c. once daily.

Other Names
Study Groups/Cohorts
Arm 1

Arm 2

Arm 3

Study Arms
Experimental Arm 1
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day

Experimental Arm 2
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day

Active Comparator Arm 3
Drug : Copaxone
20 mg administered s.c. once daily.

Arm Intervention/Treatment
Experimental Arm 1
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Experimental Arm 2
Drug : Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
Active Comparator Arm 3
Drug : Copaxone

Recruitment Information

Recruitment Status:Completed
Enrollment2244
Completion DateAugust 01, 2007
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
GenderAll
Age18 Years to 55 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Argentina
Australia
Austria
Belgium
Brazil
Canada
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Latvia
Netherlands
Norway
Poland
Russian Federation
Slovenia
Spain
Sweden
Switzerland
Ukraine
United States

Administrative Information

NCT Number:NCT00099502
Other Study ID Numbers
91162
EudraCT: 2005-002235-27
306440
Beyond
NCT00185432
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyTherapeutic Area Head,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer