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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00099502

Purpose

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

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Drug: Copaxone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Interferon beta-1b Copolymer 1 Interferons

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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

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 ]

Enrollment:	2244
Study Start Date:	November 2003
Study Completion Date:	August 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 250mcg administered s.c. every other day
Arm 2: Experimental	Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) 500mcg administered s.c. every other day
Arm 3: Active Comparator	Drug: Copaxone 20 mg administered s.c. once daily.

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099502

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35294

Cullman, Alabama, United States, 35058
United States, Arizona

Tucson, Arizona, United States, 85741-3537

Phoenix, Arizona, United States, 85013
United States, California

Sacramento, California, United States, 95817

Berkeley, California, United States, 94705

San Francisco, California, United States, 94117

La Jolla, California, United States, 92037
United States, Colorado

Englewood, Colorado, United States, 80110

Fort Collins, Colorado, United States, 80528
United States, Delaware

Wilmington, Delaware, United States, 19806
United States, District of Columbia

Washington, District of Columbia, United States, 20037
United States, Florida

Tampa, Florida, United States, 33609

Tampa, Florida, United States, 33606-3508

Miami, Florida, United States, 33125
United States, Georgia

Augusta, Georgia, United States, 30912

Atlanta, Georgia, United States, 30309-1465
United States, Illinois

Chicago, Illinois, United States, 60637-1470
United States, Indiana

Fort Wayne, Indiana, United States, 46805

Indianapolis, Indiana, United States, 46202
United States, Iowa

Des Moines, Iowa, United States, 50314
United States, Kansas

Kansas City, Kansas, United States, 66160
United States, Kentucky

Lexington, Kentucky, United States, 40536

Louisville, Kentucky, United States, 40202
United States, Louisiana

Shreveport, Louisiana, United States, 71130
United States, Michigan

Detroit, Michigan, United States, 48202
United States, Minnesota

Duluth, Minnesota, United States, 55805-1984
United States, Missouri

St. Louis, Missouri, United States, 63110
United States, Nevada

Reno, Nevada, United States, 89557-0035

Henderson, Nevada, United States, 89052
United States, New Hampshire

Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey

New Brunswick, New Jersey, United States, 08901
United States, New Mexico

Albuquerque, New Mexico, United States, 87131
United States, New York

Stony Brook, New York, United States, 11794

Rochester, New York, United States, 14642

Mineola, New York, United States, 11501-3987

Albany, New York, United States, 12208
United States, North Carolina

Durham, North Carolina, United States, 27710

Winston-Salem, North Carolina, United States, 27157-1009

Charlotte, North Carolina, United States, 28203

High Point, North Carolina, United States, 27262
United States, Ohio

Cincinnati, Ohio, United States, 45219

Columbus, Ohio, United States, 43210-1240
United States, Oregon

Tualatin, Oregon, United States, 97062
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19107

Philadelphia, Pennsylvania, United States, 19104

Pittsburgh, Pennsylvania, United States, 15213-2592
United States, Rhode Island

Providence, Rhode Island, United States, 02905
United States, South Carolina

Charleston, South Carolina, United States, 29425
United States, Tennessee

Nashville, Tennessee, United States, 37205
United States, Texas

San Antonio, Texas, United States, 78229

Houston, Texas, United States, 77030
United States, Virginia

Fairfax, Virginia, United States, 22031
United States, Washington

Seattle, Washington, United States, 98101

Tacoma, Washington, United States, 98405
United States, Wisconsin

Milwaukee, Wisconsin, United States, 53215

Marshfield, Wisconsin, United States, 54449
Argentina

Buenos Aires, Argentina, C1416CRJ

Cordoba, Argentina, X5000HGX
Argentina, Capital Federal

Buenos Aires, Capital Federal, Argentina, C1280AEB

Buenos Aires, Capital Federal, Argentina, C1117ABE
Argentina, Santa Fe

Rosario, Santa Fe, Argentina, S2000CVB

Rosario, Santa Fe, Argentina, S2000ZBL
Australia, New South Wales

Kogarah, New South Wales, Australia, 2217

Gosford, New South Wales, Australia, 2250

Liverpool, New South Wales, Australia, 2170
Australia, Victoria

Melbourne, Victoria, Australia, 3065

Parkville, Victoria, Australia, 3050
Australia, Western Australia

Nedlands, Western Australia, Australia, 6009
Austria

Linz, Austria, 4020
Austria, Niederösterreich

St. Pölten, Niederösterreich, Austria, 3100
Austria, Steiermark

Graz, Steiermark, Austria, 8036
Austria, Tirol

Innsbruck, Tirol, Austria, 6020
Belgium

BRUXELLES - BRUSSEL, Belgium, 1090

MELSBROEK, Belgium, 1820

LEUVEN, Belgium, 3000
Brazil

Sao Paulo, Brazil, 04039
Brazil, Parana

Curitiba, Parana, Brazil, 80060-900
Brazil, PE

Recife, PE, Brazil, 52010-040
Brazil, RJ

Rio de Janeiro, RJ, Brazil, 21949 900
Brazil, RS

Porto Alegre, RS, Brazil
Brazil, Sao Paulo

Campinas, Sao Paulo, Brazil, 13081- 970
Brazil, SP

Sao Paulo, SP, Brazil, 05403-900

Sao Pulo, SP, Brazil, 05651-901
Canada, Alberta

Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia

Vancouver, British Columbia, Canada, V6T 2B5
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia

Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario

Ottawa, Ontario, Canada, K1H 8L6

Toronto, Ontario, Canada, M5C 2T2

London, Ontario, Canada, N6A 5A5

Nepean, Ontario, Canada, K2G 6E2

Mississauga, Ontario, Canada, L5B 1B8
Canada, Quebec

Montreal, Quebec, Canada, H2L 4M1

Hull, Quebec, Canada, J8Y 1W7

Montreal, Quebec, Canada, H3A 2B4

Greenfield Park, Quebec, Canada, J4V 2H1
Denmark

Aarhus C, Denmark, 8000
Finland

Tampere, Finland, 33521

Oulu, Finland
France

Lille, France, 59037

Nimes, France, 30029

nancy, France, 54035

CAEN, France, F-14033

nice, France, 06000

Dijon, France, 21033

Toulouse, France, 31059

Nantes, France, 44805

Lyon, France, 69003

Clermont ferrand, France, 63003
France, Bretagne

Rennes, Bretagne, France, 35038
France, Gironde

Bordeaux, Gironde, France, 33076
Germany

Berlin, Germany, 13347

Berlin, Germany, 13578

Hamburg, Germany, 20251

Hamburg, Germany, 20099
Germany, Baden-Württemberg

Heidelberg, Baden-Württemberg, Germany, 69112
Germany, Bayern

Bayreuth, Bayern, Germany, 95445

Regensburg, Bayern, Germany, 93053
Germany, Brandenburg

Hennigsdorf, Brandenburg, Germany, 16761
Germany, Hessen

Marburg, Hessen, Germany, 35043

Gießen, Hessen, Germany, 35392

Offenbach, Hessen, Germany, 63069
Germany, Mecklenburg-Vorpommern

Greifswald, Mecklenburg-Vorpommern, Germany, 17489
Germany, Niedersachsen

Hannover, Niedersachsen, Germany, 30625

Hannover, Niedersachsen, Germany, 30171

Göttingen, Niedersachsen, Germany, 37075
Germany, Nordrhein-Westfalen

Münster, Nordrhein-Westfalen, Germany, 48149

Düsseldorf, Nordrhein-Westfalen, Germany, 40225

Essen, Nordrhein-Westfalen, Germany, 45177
Germany, Rheinland-Pfalz

Asbach, Rheinland-Pfalz, Germany, 53567
Germany, Sachsen

Dresden, Sachsen, Germany, 01307

Leipzig, Sachsen, Germany, 04129
Germany, Sachsen-Anhalt

Halle, Sachsen-Anhalt, Germany, 06120
Greece

Athens, Greece, 15127

Thessaloniki, Greece, 546 36
Greece, Attica

Athens, Attica, Greece, 11527
Hungary

Zalaegerszeg, Hungary, 8900

Györ, Hungary, 9024

Budapest, Hungary, 1076

Miskolc, Hungary, 3526

Pecs, Hungary, 7623

Budapest, Hungary, 1145
Ireland

Dublin, Ireland, 9

Dublin, Ireland, DUBLIN 4

Cork, Ireland

Dublin, Ireland, 7
Ireland, Dublin 24

Dublin, Dublin 24, Ireland
Israel

Tel-Aviv, Israel, 64239

Haifa, Israel, 34362

Jerusalem, Israel, 91120

Tel Hashomer, Israel, 52621

Petach Tikva, Israel, 49100

Zerifin, Israel, 70300

Ashkelon, Israel, 78306

Haifa, Israel, 31048
Italy, BA

Bari, BA, Italy, 70122
Italy, FI

Firenze, FI, Italy, 50134
Italy, MI

Milano, MI, Italy, 20132
Italy, PD

Padova, PD, Italy, 35128
Italy, RO

Roma, RO, Italy, 00189
Italy, to

Orbassano, to, Italy, 10043
Latvia

Riga, Latvia, LV-1015
Netherlands

SITTARD, Netherlands, 6131 BK

BREDA, Netherlands, 4819 EV
Netherlands, Gelderland

NIJMEGEN, Gelderland, Netherlands, 6533 PA
Norway

Bergen, Norway, N-5021
Poland

Wroclaw, Poland, 50-417

Katowice, Poland, 40752

Lodz, Poland, 90-153

Warszawa, Poland, 02-097

Gdansk, Poland, 80-803

Poznan, Poland, 60-355

Warszawa, Poland, 02957
Russian Federation

Moskva, Russian Federation, 127018

Moskva, Russian Federation, 123367

Moscow, Russian Federation, 117049

St. Petersburg, Russian Federation, 197022

Novosibirsk, Russian Federation, 630007

Moscow, Russian Federation, 119048

Sankt-Peterburg, Russian Federation, 197376

Moskva, Russian Federation, 129110

Yaroslavl, Russian Federation, 150039

Nizhny Novogorod, Russian Federation, 603076

Sankt-Peterburg, Russian Federation, 194044
Slovenia

Ljubljana, Slovenia, 1000

Maribor, Slovenia, 2000
Spain

Málaga, Spain, 29010

Sevilla, Spain, 41071
Spain, Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Sweden

Stockholm, Sweden, 182 88

Uppsala, Sweden, 75185

Helsingborg, Sweden, 25278
Switzerland

Bern, Switzerland, 3010

St. Gallen, Switzerland, 9007
Ukraine

Kiev, Ukraine, 03110

Donetsk, Ukraine, 83003

Kharkiv, Ukraine, 61068

Lviv, Ukraine, 79000

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group; O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Harung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. Epub 2009 Sep 2.

Responsible Party:	Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head )
Study ID Numbers:	91162, EudraCT: 2005-002235-27, 306440, Beyond
Study First Received:	December 15, 2004
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00099502 History of Changes
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Canada: Health Canada; Sweden: Medical Products Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Canada: Health Canada; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ministry of Health and Welfare; Ireland: Irish Medicines Board; Italy: Ministry of Health; Latvia: State Agency of Medicines; Netherlands: Dutch Health Care Inspectorate; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Slovenia: Ministry of Health; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; Ukraine: Ministry of Health; United States: Food and Drug Administration

Keywords provided by Bayer:

Relapsing multiple sclerosis
interferon beta 1b
Betaferon
Betaseron

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases

Demyelinating Diseases
Growth Substances
Interferons
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta
Sclerosis
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Copolymer 1
Interferon beta-1b
Demyelinating Autoimmune Diseases, CNS

ClinicalTrials.gov processed this record on November 30, 2009