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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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

Clinical Details

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hazard ratio for relapses

Secondary outcome:

Time to confirmed Expanded Disability Status Score (EDSS) progression

Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

Buenos Aires C1416CRJ, Argentina

Cordoba X5000HGX, Argentina

Linz 4020, Austria

Bruxelles - Brussel 1090, Belgium

Leuven 3000, Belgium

Melsbroek 1820, Belgium

Sao Paulo 04039, Brazil

Aarhus C 8000, Denmark

Oulu, Finland

Tampere 33521, Finland

Caen F-14033, France

Clermont ferrand 63003, France

Dijon 21033, France

Lille 59037, France

Lyon 69003, France

Nancy 54035, France

Nantes 44805, France

Nice 06000, France

Nimes 30029, France

Toulouse 31059, France

Berlin 13347, Germany

Berlin 13578, Germany

Hamburg 20251, Germany

Hamburg 20099, Germany

Athens 15127, Greece

Thessaloniki 546 36, Greece

Budapest 1145, Hungary

Budapest 1076, Hungary

Györ 9024, Hungary

Miskolc 3526, Hungary

Pecs 7623, Hungary

Zalaegerszeg 8900, Hungary

Cork, Ireland

Dublin 7, Ireland

Dublin 9, Ireland

Dublin DUBLIN 4, Ireland

Ashkelon 78306, Israel

Haifa 31048, Israel

Haifa 34362, Israel

Jerusalem 91120, Israel

Petach Tikva 49100, Israel

Tel Hashomer 52621, Israel

Tel-Aviv 64239, Israel

Zerifin 70300, Israel

Riga LV-1015, Latvia

Breda 4819 EV, Netherlands

Sittard 6131 BK, Netherlands

Bergen N-5021, Norway

Gdansk 80-803, Poland

Katowice 40752, Poland

Lodz 90-153, Poland

Poznan 60-355, Poland

Warszawa 02-097, Poland

Warszawa 02957, Poland

Wroclaw 50-417, Poland

Moscow 119048, Russian Federation

Moscow 117049, Russian Federation

Moskva 129110, Russian Federation

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Nizhny Novogorod 603076, Russian Federation

Novosibirsk 630007, Russian Federation

Sankt-Peterburg 194044, Russian Federation

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St. Petersburg 197022, Russian Federation

Yaroslavl 150039, Russian Federation

Ljubljana 1000, Slovenia

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Sevilla 41071, Spain

Helsingborg 25278, Sweden

Stockholm 182 88, Sweden

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Bern 3010, Switzerland

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Donetsk 83003, Ukraine

Kharkiv 61068, Ukraine

Kiev 03110, Ukraine

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Bari, BA 70122, Italy

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Starting date: November 2003
Last updated: December 18, 2008

Page last updated: August 20, 2015

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