BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
NCT ID: NCT00099502
Last Updated: 2008-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2244 participants
INTERVENTIONAL
2003-11-30
2007-08-31
Brief Summary
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* 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
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Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Arm 2
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Arm 3
Copaxone
20 mg administered s.c. once daily.
Interventions
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Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
Copaxone
20 mg administered s.c. once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare Pharmaceuticals, Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Cullman, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Berkeley, California, United States
La Jolla, California, United States
Sacramento, California, United States
San Francisco, California, United States
Englewood, Colorado, United States
Fort Collins, Colorado, United States
Wilmington, Delaware, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Shreveport, Louisiana, United States
Detroit, Michigan, United States
Duluth, Minnesota, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
Reno, Nevada, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Mineola, New York, United States
Rochester, New York, United States
Stony Brook, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
High Point, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Tualatin, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Marshfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Gosford, New South Wales, Australia
Kogarah, New South Wales, Australia
Liverpool, New South Wales, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Sankt Pölten, Lower Austria, Austria
Graz, Styria, Austria
Innsbruck, Tyrol, Austria
Linz, , Austria
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Melsbroek, , Belgium
Curitiba, Paraná, Brazil
Recife, Pernambuco, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Campinas, São Paulo, Brazil
Sao Pulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Nepean, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Greenfield Park, Quebec, Canada
Hull, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Aarhus C, , Denmark
Oulu, , Finland
Tampere, , Finland
Rennes, Brittany Region, France
Bordeaux, Gironde, France
Caen, , France
Clermont-Ferrand, , France
Dijon, , France
Lille, , France
Lyon, , France
Nancy, , France
Nantes, , France
Nice, , France
Nîmes, , France
Toulouse, , France
Heidelberg, Baden-Wurttemberg, Germany
Bayreuth, Bavaria, Germany
Regensburg, Bavaria, Germany
Hennigsdorf, Brandenburg, Germany
Hamburg, City state of Hamburg, Germany
Hamburg, City state of Hamburg, Germany
Giessen, Hesse, Germany
Marburg, Hesse, Germany
Offenbach, Hesse, Germany
Göttingen, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Hanover, Lower Saxony, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Essen, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Asbach, Rhineland-Palatinate, Germany
Dresden, Saxony, Germany
Leipzig, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Athens, Attica, Greece
Thessaloniki, Thessaloniki, Greece
Athens, , Greece
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Zalaegerszeg, , Hungary
Dublin, Dublin 24, Ireland
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Bari, BA, Italy
Florence, FI, Italy
Milan, MI, Italy
Padua, PD, Italy
Roma, RO, Italy
Orbassano, TO, Italy
Riga, , Latvia
Nijmegen, Gelderland, Netherlands
Breda, , Netherlands
Sittard, , Netherlands
Bergen, , Norway
Gdansk, , Poland
Katowice, , Poland
Lodz, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Moscow, , Russia
Moscow, , Russia
Moskva, , Russia
Moskva, , Russia
Moskva, , Russia
Nizhny Novogorod, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Ljubljana, , Slovenia
Maribor, , Slovenia
L'Hospitalet de Llobregat, Barcelona, Spain
Málaga, Málaga, Spain
Seville, Sevilla, Spain
Helsingborg, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Bern, Canton of Bern, Switzerland
Sankt Gallen, Canton of St. Gallen, Switzerland
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Countries
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References
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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, Hartung 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. doi: 10.1016/S1474-4422(09)70226-1. Epub 2009 Sep 2.
Other Identifiers
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EudraCT: 2005-002235-27
Identifier Type: -
Identifier Source: secondary_id
306440
Identifier Type: -
Identifier Source: secondary_id
Beyond
Identifier Type: -
Identifier Source: secondary_id
91162
Identifier Type: -
Identifier Source: org_study_id
NCT00185432
Identifier Type: -
Identifier Source: nct_alias