Multiple Sclerosis, Relapsing-RemittingPhase 3NCT00099502
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
A Phase 3 study testing Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) and Copaxone in people with Multiple Sclerosis, Relapsing-Remitting, run by Bayer at 199 sites in 26 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) and Copaxone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,244 participants
- Where
- 199 sitesin 26 countries
- Study dates
- Nov 2003to Aug 2007
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
199 sites in 26 countries.
199 sites in 26 countries
United States57 sites
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Albany, New York, 12208
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Albuquerque, New Mexico, 87131
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Atlanta, Georgia, 30309-1465
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Augusta, Georgia, 30912
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Berkeley, California, 94705
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Birmingham, Alabama, 35294
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28203
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Chicago, Illinois, 60637-1470
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Cincinnati, Ohio, 45219
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Columbus, Ohio, 43210-1240
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Cullman, Alabama, 35058
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Des Moines, Iowa, 50314
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Detroit, Michigan, 48202
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Duluth, Minnesota, 55805-1984
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Durham, North Carolina, 27710
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Englewood, Colorado, 80110
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Fairfax, Virginia, 22031
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Fort Collins, Colorado, 80528
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Fort Wayne, Indiana, 46805
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Henderson, Nevada, 89052
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High Point, North Carolina, 27262
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Houston, Texas, 77030
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Indianapolis, Indiana, 46202
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Kansas City, Kansas, 66160
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La Jolla, California, 92037
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Lebanon, New Hampshire, 03756-0001
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Lexington, Kentucky, 40536
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Louisville, Kentucky, 40202
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Marshfield, Wisconsin, 54449
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Miami, Florida, 33125
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Milwaukee, Wisconsin, 53215
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Mineola, New York, 11501-3987
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Nashville, Tennessee, 37205
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New Brunswick, New Jersey, 08901
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19107
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Phoenix, Arizona, 85013
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Pittsburgh, Pennsylvania, 15213-2592
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Providence, Rhode Island, 02905
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Reno, Nevada, 89557-0035
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Rochester, New York, 14642
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Sacramento, California, 95817
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San Antonio, Texas, 78229
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San Francisco, California, 94117
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Seattle, Washington, 98101
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Shreveport, Louisiana, 71130
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St Louis, Missouri, 63110
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Stony Brook, New York, 11794
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Tacoma, Washington, 98405
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Tampa, Florida, 33606-3508
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Tampa, Florida, 33609
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Tualatin, Oregon, 97062
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Tucson, Arizona, 85741-3537
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Washington D.C., District of Columbia, 20037
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Wilmington, Delaware, 19806
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Winston-Salem, North Carolina, 27157-1009
Germany22 sites
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Asbach, Rhineland-Palatinate, 53567
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Bayreuth, Bavaria, 95445
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Berlin, State of Berlin, 13347
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Berlin, State of Berlin, 13578
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Dresden, Saxony, 01307
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Düsseldorf, North Rhine-Westphalia, 40225
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Essen, North Rhine-Westphalia, 45177
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Giessen, Hesse, 35392
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Göttingen, Lower Saxony, 37075
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Greifswald, Mecklenburg-Vorpommern, 17489
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Halle, Saxony-Anhalt, 06120
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Hamburg, Free and Hanseatic City of Hamburg, 20099
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Hamburg, Free and Hanseatic City of Hamburg, 20251
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Hanover, Lower Saxony, 30171
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Hanover, Lower Saxony, 30625
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Heidelberg, Baden-Wurttemberg, 69112
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Hennigsdorf, Brandenburg, 16761
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Leipzig, Saxony, 04129
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Marburg, Hesse, 35043
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Münster, North Rhine-Westphalia, 48149
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Offenbach, Hesse, 63069
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Regensburg, Bavaria, 93053
Canada13 sites
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Calgary, Alberta, T2N 2T9
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Greenfield Park, Quebec, J4V 2H1
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Halifax, Nova Scotia, B3H 3A7
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Hull, Quebec, J8Y 1W7
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London, Ontario, N6A 5A5
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Mississauga, Ontario, L5B 1B8
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Montreal, Quebec, H2L 4M1
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Montreal, Quebec, H3A 2B4
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Nepean, Ontario, K2G 6E2
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Ottawa, Ontario, K1H 8L6
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Toronto, Ontario, M5C 2T2
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Vancouver, British Columbia, V6T 2B5
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Winnipeg, Manitoba, R3A 1R9
France12 sites
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Bordeaux, Gironde, 33076
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Caen, F-14033
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Clermont-Ferrand, 63003
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Dijon, 21033
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Lille, 59037
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Lyon, 69003
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Nancy, 54035
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Nantes, 44805
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Nice, 06000
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Nîmes, 30029
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Rennes, Brittany Region, 35038
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Toulouse, 31059
Russia11 sites
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Moscow, 117049
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Moscow, 119048
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Moskva, 123367
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Moskva, 127018
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Moskva, 129110
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Nizhny Novogorod, 603076
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Novosibirsk, 630007
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Saint Petersburg, 194044
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Saint Petersburg, 197022
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Saint Petersburg, 197376
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Yaroslavl, 150039
Brazil8 sites
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Campinas, São Paulo, 13081- 970
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Curitiba, Paraná, 80060-900
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Porto Alegre, Rio Grande do Sul
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Recife, Pernambuco, 52010-040
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Rio de Janeiro, Rio de Janeiro, 21949 900
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São Paulo, São Paulo, 04039
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São Paulo, São Paulo, 05403-900
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Sao Pulo, São Paulo, 05651-901
Israel8 sites
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Ashkelon, 78306
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Haifa, 31048
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Haifa, 34362
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Jerusalem, 91120
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Petah Tikva, 49100
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Tel Aviv, 64239
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Tel Litwinsky, 52621
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Ẕerifin, 70300
Poland7 sites
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Gdansk, 80-803
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Katowice, 40752
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Lodz, 90-153
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Poznan, 60-355
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Warsaw, 02-097
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Warsaw, 02957
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Wroclaw, 50-417
Argentina6 sites
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Buenos Aires, Buenos Aires, C1416CRJ
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Buenos Aires, Buenos Aires F.D., C1117ABE
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Buenos Aires, Buenos Aires F.D., C1280AEB
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Córdoba, Córdoba Province, X5000HGX
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Rosario, Santa Fe Province, S2000CVB
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Rosario, Santa Fe Province, S2000ZBL
Australia6 sites
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Gosford, New South Wales, 2250
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Kogarah, New South Wales, 2217
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Liverpool, New South Wales, 2170
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Melbourne, Victoria, 3065
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Nedlands, Western Australia, 6009
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Parkville, Victoria, 3050
Hungary6 sites
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Budapest, 1076
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Budapest, 1145
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Győr, 9024
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Miskolc, 3526
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Pécs, 7623
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Zalaegerszeg, 8900
Italy6 sites
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Bari, BA, 70122
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Florence, FI, 50134
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Milan, MI, 20132
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Orbassano, TO, 10043
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Padova, PD, 35128
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Roma, RO, 00189
Ireland5 sites
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Cork
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Dublin, Dublin 24
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Dublin, 7
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Dublin, 9
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Dublin, DUBLIN 4
Austria4 sites
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Graz, Styria, 8036
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Innsbruck, Tyrol, 6020
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Linz, 4020
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Sankt Pölten, Lower Austria, 3100
Ukraine4 sites
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Donetsk, 83003
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Kharkiv, 61068
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Kiev, 03110
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Lviv, 79000
Belgium3 sites
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Bruxelles - Brussel, 1090
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Leuven, 3000
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Melsbroek, 1820
Greece3 sites
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Athens, Attica, 11527
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Athens, 15127
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Thessaloniki, Thessaloniki, 546 36
Netherlands3 sites
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Breda, 4819 EV
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Nijmegen, Gelderland, 6533 PA
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Sittard, 6131 BK
Spain3 sites
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L'Hospitalet de Llobregat, Barcelona, 08907
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Málaga, Málaga, 29010
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Seville, Sevilla, 41071
Sweden3 sites
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Helsingborg, 25278
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Stockholm, 182 88
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Uppsala, 75185
Switzerland2 sites
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Bern, Canton of Bern, 3010
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Sankt Gallen, Canton of St. Gallen, 9007
About this 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.
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
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Interferon beta-1b (Betaferon/Betaseron, BAY86-5046), Copaxone
- Keywords
- Relapsing multiple sclerosis, interferon beta 1b, Betaferon, Betaseron
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)Drug
250mcg administered s.c. every other day
Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)Drug
500mcg administered s.c. every other day
CopaxoneDrug
20 mg administered s.c. once daily.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 2 | Experimental | Not described Receives: Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) |
| Arm 3 | Active comparator | Not described Receives: Drug: Copaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard ratio for relapses
Measured: During the first and during the second 52 weeks
Secondary outcomes (2)
Time to confirmed Expanded Disability Status Score (EDSS) progression
Measured: After 52 and after 104 weeks
Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
Measured: After 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2004 (estimated)
- Study startNov 2003
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099502
- Sponsor's protocol ID
- 91162
- Other IDs
- EudraCT: 2005-002235-27, 306440, Beyond
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2004
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19729344