Clinical trial NCT00459667: BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Official title: International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg
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: 2007-04-12
Enrollment: 1420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Detailed description: Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

Eligibility criteria: Inclusion Criteria:

* Completion of the BEYOND study 306440 as scheduled
* Relapsing multiple sclerosis
* Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
* Females of child-bearing potential:

  * Agreement to practice adequate contraception methods and
  * Negative pregnancy test and
  * No lactation
* Written informed consent

Exclusion Criteria:

* Serious or acute heart diseases
* History of severe depression or suicide attempt
* Epilepsy not adequately controlled by treatment
* Known allergy to IFNs, to human albumin or to mannitol
* Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Primary outcomes:
measure: Flu-like-syndrome
timeFrame: 309 days
measure: Injection-site Reactions
timeFrame: 309 days
measure: Liver Enzyme Elevations
timeFrame: 309 days
measure: Hematological Abnormalities
timeFrame: 309 days
Secondary outcomes:
measure: Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
timeFrame: 309 days
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: Fort Collins
country: United States
state: Colorado
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Maitland
country: United States
state: Florida
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: 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: Newark
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
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: 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: 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: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Cordoba
country: Argentina
state: Córdoba
city: Rosario
country: Argentina
state: Santa Fe
city: Rosario
country: Argentina
state: Santa Fe
city: Buenos Aires
country: Argentina
city: Kogarah
country: Australia
state: New South Wales
city: Fitzroy
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Liverpool
country: Australia
city: Wyoming
country: Australia
city: St Poelten
country: Austria
state: Niederösterreich
city: Graz
country: Austria
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Brussel
country: Belgium
city: Leuven
country: Belgium
city: Melsbroek
country: Belgium
city: Curitiba
country: Brazil
state: Parana
city: Recife
country: Brazil
state: Pernambuco
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Campinas
country: Brazil
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
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
country: Denmark
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Rennes
country: France
state: Bretagne
city: Bordeaux
country: France
state: Gironde
city: Clermont ferrand
country: France
city: Dijon
country: France
city: Lille
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: 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: 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-Pozva
country: Hungary
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: Jerusalem
country: Israel
city: Tel Hashomer
country: Israel
city: Tel-Aviv
country: Israel
city: Zerifin
country: Israel
city: Orbassano
country: Italy
state: Torino
city: Bari
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Riga
country: Latvia
city: Breda
country: Netherlands
city: Nijmegen
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: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Moskva
country: Russian Federation
city: Nizhy Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Sankt-Peterburg
country: Russian Federation
city: St. Petersburg
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: Malaga
country: Spain
city: Sevilla
country: Spain
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: Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.