Clinical trial NCT00099502: BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing multiple sclerosis
interferon beta 1b
Betaferon
Betaseron
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2004-12-16
Enrollment: 2244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hazard ratio for relapses
timeFrame: During the first and during the second 52 weeks
Secondary outcomes:
measure: Time to confirmed Expanded Disability Status Score (EDSS) progression
timeFrame: After 52 and after 104 weeks
measure: Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
timeFrame: After 104 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Cullman
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Wilmington
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Fort Wayne
country: United States
state: Indiana
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Duluth
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: New Brunswick
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Tualatin
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Rosario
country: Argentina
state: Santa Fe
city: Rosario
country: Argentina
state: Santa Fe
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Gosford
country: Australia
state: New South Wales
city: Kogarah
country: Australia
state: New South Wales
city: Liverpool
country: Australia
state: New South Wales
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: St. Pölten
country: Austria
state: Niederösterreich
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Linz
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Leuven
country: Belgium
city: Melsbroek
country: Belgium
city: Curitiba
country: Brazil
state: Parana
city: Recife
country: Brazil
state: PE
city: Rio de Janeiro
country: Brazil
state: RJ
city: Porto Alegre
country: Brazil
state: RS
city: Campinas
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
state: SP
city: Sao Pulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: Nepean
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Hull
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Aarhus C
country: Denmark
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Rennes
country: France
state: Bretagne
city: Bordeaux
country: France
state: Gironde
city: Caen
country: France
city: Clermont ferrand
country: France
city: Dijon
country: France
city: Lille
country: France
city: Lyon
country: France
city: Nancy
country: France
city: Nantes
country: France
city: Nice
country: France
city: Nimes
country: France
city: Toulouse
country: France
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Bayreuth
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Hennigsdorf
country: Germany
state: Brandenburg
city: Gießen
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Offenbach
country: Germany
state: Hessen
city: Greifswald
country: Germany
state: Mecklenburg-Vorpommern
city: Göttingen
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Asbach
country: Germany
state: Rheinland-Pfalz
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Athens
country: Greece
state: Attica
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Györ
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Dublin
country: Ireland
state: Dublin 24
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Dublin
country: Ireland
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Tel Hashomer
country: Israel
city: Tel-Aviv
country: Israel
city: Zerifin
country: Israel
city: Bari
country: Italy
state: BA
city: Firenze
country: Italy
state: FI
city: Milano
country: Italy
state: MI
city: Padova
country: Italy
state: PD
city: Roma
country: Italy
state: RO
city: Orbassano
country: Italy
state: TO
city: Riga
country: Latvia
city: Nijmegen
country: Netherlands
state: Gelderland
city: Breda
country: Netherlands
city: Sittard
country: Netherlands
city: Bergen
country: Norway
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Nizhny Novogorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Málaga
country: Spain
city: Sevilla
country: Spain
city: Helsingborg
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: Bern
country: Switzerland
city: St. Gallen
country: Switzerland
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.