| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2005-002235-27 | |||
| 306440 | |||
| Beyond |
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The purpose of this study is to determine
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Drug | 250mcg administered s.c. every other day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hazard ratio for relapses | During the first and during the second 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to confirmed Expanded Disability Status Score (EDSS) progression | After 52 and after 104 weeks | |
| Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images | After 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19729344 | Derived | 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. |
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| Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) | Drug | 500mcg administered s.c. every other day |
|
| Copaxone | Drug | 20 mg administered s.c. once daily. |
|
| Cullman |
| Alabama |
| 35058 |
| United States |
| Phoenix | Arizona | 85013 | United States |
| Tucson | Arizona | 85741-3537 | United States |
| Berkeley | California | 94705 | United States |
| La Jolla | California | 92037 | United States |
| Sacramento | California | 95817 | United States |
| San Francisco | California | 94117 | United States |
| Englewood | Colorado | 80110 | United States |
| Fort Collins | Colorado | 80528 | United States |
| Wilmington | Delaware | 19806 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Miami | Florida | 33125 | United States |
| Tampa | Florida | 33606-3508 | United States |
| Tampa | Florida | 33609 | United States |
| Atlanta | Georgia | 30309-1465 | United States |
| Augusta | Georgia | 30912 | United States |
| Chicago | Illinois | 60637-1470 | United States |
| Fort Wayne | Indiana | 46805 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Des Moines | Iowa | 50314 | United States |
| Kansas City | Kansas | 66160 | United States |
| Lexington | Kentucky | 40536 | United States |
| Louisville | Kentucky | 40202 | United States |
| Shreveport | Louisiana | 71130 | United States |
| Detroit | Michigan | 48202 | United States |
| Duluth | Minnesota | 55805-1984 | United States |
| St Louis | Missouri | 63110 | United States |
| Henderson | Nevada | 89052 | United States |
| Reno | Nevada | 89557-0035 | United States |
| Lebanon | New Hampshire | 03756-0001 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Albany | New York | 12208 | United States |
| Mineola | New York | 11501-3987 | United States |
| Rochester | New York | 14642 | United States |
| Stony Brook | New York | 11794 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27710 | United States |
| High Point | North Carolina | 27262 | United States |
| Winston-Salem | North Carolina | 27157-1009 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Columbus | Ohio | 43210-1240 | United States |
| Tualatin | Oregon | 97062 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15213-2592 | United States |
| Providence | Rhode Island | 02905 | United States |
| Charleston | South Carolina | 29425 | United States |
| Nashville | Tennessee | 37205 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 78229 | United States |
| Fairfax | Virginia | 22031 | United States |
| Seattle | Washington | 98101 | United States |
| Tacoma | Washington | 98405 | United States |
| Marshfield | Wisconsin | 54449 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| Buenos Aires | Buenos Aires | C1416CRJ | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1117ABE | Argentina |
| Buenos Aires | Buenos Aires F.D. | C1280AEB | Argentina |
| Córdoba | Córdoba Province | X5000HGX | Argentina |
| Rosario | Santa Fe Province | S2000CVB | Argentina |
| Rosario | Santa Fe Province | S2000ZBL | Argentina |
| Gosford | New South Wales | 2250 | Australia |
| Kogarah | New South Wales | 2217 | Australia |
| Liverpool | New South Wales | 2170 | Australia |
| Melbourne | Victoria | 3065 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Sankt Pölten | Lower Austria | 3100 | Austria |
| Graz | Styria | 8036 | Austria |
| Innsbruck | Tyrol | 6020 | Austria |
| Linz | 4020 | Austria |
| Bruxelles - Brussel | 1090 | Belgium |
| Leuven | 3000 | Belgium |
| Melsbroek | 1820 | Belgium |
| Curitiba | Paraná | 80060-900 | Brazil |
| Recife | Pernambuco | 52010-040 | Brazil |
| Rio de Janeiro | Rio de Janeiro | 21949 900 | Brazil |
| Porto Alegre | Rio Grande do Sul | Brazil |
| Campinas | São Paulo | 13081- 970 | Brazil |
| Sao Pulo | São Paulo | 05651-901 | Brazil |
| São Paulo | São Paulo | 04039 | Brazil |
| São Paulo | São Paulo | 05403-900 | Brazil |
| Calgary | Alberta | T2N 2T9 | Canada |
| Vancouver | British Columbia | V6T 2B5 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Halifax | Nova Scotia | B3H 3A7 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Mississauga | Ontario | L5B 1B8 | Canada |
| Nepean | Ontario | K2G 6E2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5C 2T2 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Hull | Quebec | J8Y 1W7 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Montreal | Quebec | H3A 2B4 | Canada |
| Aarhus C | 8000 | Denmark |
| Oulu | Finland |
| Tampere | 33521 | Finland |
| Rennes | Brittany Region | 35038 | France |
| Bordeaux | Gironde | 33076 | France |
| 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 |
| Nîmes | 30029 | France |
| Toulouse | 31059 | France |
| Heidelberg | Baden-Wurttemberg | 69112 | Germany |
| Bayreuth | Bavaria | 95445 | Germany |
| Regensburg | Bavaria | 93053 | Germany |
| Hennigsdorf | Brandenburg | 16761 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20099 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
| Giessen | Hesse | 35392 | Germany |
| Marburg | Hesse | 35043 | Germany |
| Offenbach | Hesse | 63069 | Germany |
| Göttingen | Lower Saxony | 37075 | Germany |
| Hanover | Lower Saxony | 30171 | Germany |
| Hanover | Lower Saxony | 30625 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17489 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Essen | North Rhine-Westphalia | 45177 | Germany |
| Münster | North Rhine-Westphalia | 48149 | Germany |
| Asbach | Rhineland-Palatinate | 53567 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04129 | Germany |
| Halle | Saxony-Anhalt | 06120 | Germany |
| Berlin | State of Berlin | 13347 | Germany |
| Berlin | State of Berlin | 13578 | Germany |
| Athens | Attica | 11527 | Greece |
| Thessaloniki | Thessaloniki | 546 36 | Greece |
| Athens | 15127 | Greece |
| Budapest | 1076 | Hungary |
| Budapest | 1145 | Hungary |
| Győr | 9024 | Hungary |
| Miskolc | 3526 | Hungary |
| Pécs | 7623 | Hungary |
| Zalaegerszeg | 8900 | Hungary |
| Dublin | Dublin 24 | Ireland |
| Cork | Ireland |
| Dublin | 7 | Ireland |
| Dublin | 9 | Ireland |
| Dublin | DUBLIN 4 | Ireland |
| Ashkelon | 78306 | Israel |
| Haifa | 31048 | Israel |
| Haifa | 34362 | Israel |
| Jerusalem | 91120 | Israel |
| Petah Tikva | 49100 | Israel |
| Tel Aviv | 64239 | Israel |
| Tel Litwinsky | 52621 | Israel |
| Ẕerifin | 70300 | Israel |
| Bari | BA | 70122 | Italy |
| Florence | FI | 50134 | Italy |
| Milan | MI | 20132 | Italy |
| Padova | PD | 35128 | Italy |
| Roma | RO | 00189 | Italy |
| Orbassano | TO | 10043 | Italy |
| Riga | LV-1015 | Latvia |
| Nijmegen | Gelderland | 6533 PA | Netherlands |
| 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 |
| Warsaw | 02-097 | Poland |
| Warsaw | 02957 | Poland |
| Wroclaw | 50-417 | Poland |
| Moscow | 117049 | Russia |
| Moscow | 119048 | Russia |
| Moskva | 123367 | Russia |
| Moskva | 127018 | Russia |
| Moskva | 129110 | Russia |
| Nizhny Novogorod | 603076 | Russia |
| Novosibirsk | 630007 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 197022 | Russia |
| Saint Petersburg | 197376 | Russia |
| Yaroslavl | 150039 | Russia |
| Ljubljana | 1000 | Slovenia |
| Maribor | 2000 | Slovenia |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Málaga | Málaga | 29010 | Spain |
| Seville | Sevilla | 41071 | Spain |
| Helsingborg | 25278 | Sweden |
| Stockholm | 182 88 | Sweden |
| Uppsala | 75185 | Sweden |
| Bern | Canton of Bern | 3010 | Switzerland |
| Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Donetsk | 83003 | Ukraine |
| Kharkiv | 61068 | Ukraine |
| Kiev | 03110 | Ukraine |
| Lviv | 79000 | Ukraine |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068576 | Interferon beta-1b |
| D000068717 | Glatiramer Acetate |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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