BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
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.
4 other identifiers
interventional
2,244
25 countries
195
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
Typical duration for phase_3
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 15, 2004
CompletedFirst Posted
Study publicly available on registry
December 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 19, 2008
December 1, 2008
December 15, 2004
December 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hazard ratio for relapses
During the first and during the second 52 weeks
Secondary Outcomes (2)
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
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
ACTIVE COMPARATORInterventions
250mcg administered s.c. every other day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (199)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Cullman, Alabama, 35058, United States
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Phoenix, Arizona, 85013, United States
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Tucson, Arizona, 85741-3537, United States
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Berkeley, California, 94705, United States
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La Jolla, California, 92037, United States
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Sacramento, California, 95817, United States
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San Francisco, California, 94117, United States
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Englewood, Colorado, 80110, United States
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Fort Collins, Colorado, 80528, United States
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Wilmington, Delaware, 19806, United States
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Washington D.C., District of Columbia, 20037, United States
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Miami, Florida, 33125, United States
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Tampa, Florida, 33606-3508, United States
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Tampa, Florida, 33609, United States
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Atlanta, Georgia, 30309-1465, United States
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Augusta, Georgia, 30912, United States
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Chicago, Illinois, 60637-1470, United States
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Fort Wayne, Indiana, 46805, United States
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Indianapolis, Indiana, 46202, United States
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Des Moines, Iowa, 50314, United States
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Kansas City, Kansas, 66160, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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Shreveport, Louisiana, 71130, United States
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Detroit, Michigan, 48202, United States
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Duluth, Minnesota, 55805-1984, United States
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St Louis, Missouri, 63110, United States
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Henderson, Nevada, 89052, United States
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Reno, Nevada, 89557-0035, United States
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Lebanon, New Hampshire, 03756-0001, United States
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New Brunswick, New Jersey, 08901, United States
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Albuquerque, New Mexico, 87131, United States
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Albany, New York, 12208, United States
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Mineola, New York, 11501-3987, United States
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Rochester, New York, 14642, United States
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Stony Brook, New York, 11794, United States
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Charlotte, North Carolina, 28203, United States
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Durham, North Carolina, 27710, United States
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High Point, North Carolina, 27262, United States
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Winston-Salem, North Carolina, 27157-1009, United States
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Cincinnati, Ohio, 45219, United States
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Columbus, Ohio, 43210-1240, United States
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Tualatin, Oregon, 97062, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15213-2592, United States
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Providence, Rhode Island, 02905, United States
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Charleston, South Carolina, 29425, United States
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Nashville, Tennessee, 37205, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Fairfax, Virginia, 22031, United States
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Seattle, Washington, 98101, United States
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Tacoma, Washington, 98405, United States
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Marshfield, Wisconsin, 54449, United States
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Milwaukee, Wisconsin, 53215, United States
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Buenos Aires, Buenos Aires, C1416CRJ, Argentina
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Buenos Aires, Buenos Aires F.D., C1117ABE, Argentina
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Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina
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Córdoba, Córdoba Province, X5000HGX, Argentina
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Rosario, Santa Fe Province, S2000CVB, Argentina
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Rosario, Santa Fe Province, S2000ZBL, Argentina
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Gosford, New South Wales, 2250, Australia
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Kogarah, New South Wales, 2217, Australia
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Liverpool, New South Wales, 2170, Australia
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Melbourne, Victoria, 3065, Australia
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Parkville, Victoria, 3050, Australia
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Nedlands, Western Australia, 6009, Australia
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Sankt Pölten, Lower Austria, 3100, Austria
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Graz, Styria, 8036, Austria
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Innsbruck, Tyrol, 6020, Austria
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Linz, 4020, Austria
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Bruxelles - Brussel, 1090, Belgium
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Leuven, 3000, Belgium
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Melsbroek, 1820, Belgium
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Curitiba, Paraná, 80060-900, Brazil
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Recife, Pernambuco, 52010-040, Brazil
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Rio de Janeiro, Rio de Janeiro, 21949 900, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, 13081- 970, Brazil
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Sao Pulo, São Paulo, 05651-901, Brazil
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São Paulo, São Paulo, 04039, Brazil
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São Paulo, São Paulo, 05403-900, Brazil
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Calgary, Alberta, T2N 2T9, Canada
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Vancouver, British Columbia, V6T 2B5, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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London, Ontario, N6A 5A5, Canada
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Mississauga, Ontario, L5B 1B8, Canada
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Nepean, Ontario, K2G 6E2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5C 2T2, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Hull, Quebec, J8Y 1W7, Canada
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Montreal, Quebec, H2L 4M1, Canada
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Montreal, Quebec, H3A 2B4, Canada
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Aarhus C, 8000, Denmark
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Oulu, Finland
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Tampere, 33521, Finland
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Rennes, Brittany Region, 35038, France
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Bordeaux, Gironde, 33076, France
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Caen, F-14033, France
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Clermont-Ferrand, 63003, France
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Dijon, 21033, France
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Lille, 59037, France
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Lyon, 69003, France
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Nancy, 54035, France
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Nantes, 44805, France
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Nice, 06000, France
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Nîmes, 30029, France
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Toulouse, 31059, France
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Heidelberg, Baden-Wurttemberg, 69112, Germany
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Bayreuth, Bavaria, 95445, Germany
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Regensburg, Bavaria, 93053, Germany
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Hennigsdorf, Brandenburg, 16761, Germany
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Hamburg, Hamburg, 20099, Germany
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Hamburg, Hamburg, 20251, Germany
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Giessen, Hesse, 35392, Germany
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Marburg, Hesse, 35043, Germany
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Offenbach, Hesse, 63069, Germany
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Göttingen, Lower Saxony, 37075, Germany
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Hanover, Lower Saxony, 30171, Germany
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Hanover, Lower Saxony, 30625, Germany
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Greifswald, Mecklenburg-Vorpommern, 17489, Germany
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Düsseldorf, North Rhine-Westphalia, 40225, Germany
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Essen, North Rhine-Westphalia, 45177, Germany
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Münster, North Rhine-Westphalia, 48149, Germany
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Asbach, Rhineland-Palatinate, 53567, Germany
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Dresden, Saxony, 01307, Germany
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Leipzig, Saxony, 04129, Germany
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Halle, Saxony-Anhalt, 06120, Germany
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Berlin, State of Berlin, 13347, Germany
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Berlin, State of Berlin, 13578, Germany
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Athens, Attica, 11527, Greece
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Thessaloniki, Thessaloniki, 546 36, Greece
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Athens, 15127, Greece
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Budapest, 1076, Hungary
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Budapest, 1145, Hungary
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Győr, 9024, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7623, Hungary
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Zalaegerszeg, 8900, Hungary
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Dublin, Dublin 24, Ireland
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Cork, Ireland
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Dublin, 7, Ireland
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Dublin, 9, Ireland
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Dublin, DUBLIN 4, Ireland
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Ashkelon, 78306, Israel
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Haifa, 31048, Israel
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Haifa, 34362, Israel
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Jerusalem, 91120, Israel
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Petah Tikva, 49100, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Ẕerifin, 70300, Israel
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Bari, BA, 70122, Italy
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Florence, FI, 50134, Italy
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Milan, MI, 20132, Italy
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Padua, PD, 35128, Italy
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Roma, RO, 00189, Italy
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Orbassano, TO, 10043, Italy
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Riga, LV-1015, Latvia
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Nijmegen, Gelderland, 6533 PA, Netherlands
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Breda, 4819 EV, Netherlands
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Sittard, 6131 BK, Netherlands
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Bergen, N-5021, Norway
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Gdansk, 80-803, Poland
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Katowice, 40752, Poland
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Lodz, 90-153, Poland
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Poznan, 60-355, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02957, Poland
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Wroclaw, 50-417, Poland
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Moscow, 117049, Russia
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Moscow, 119048, Russia
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Moskva, 123367, Russia
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Moskva, 127018, Russia
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Moskva, 129110, Russia
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Nizhny Novogorod, 603076, Russia
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Novosibirsk, 630007, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197376, Russia
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Yaroslavl, 150039, Russia
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Málaga, Málaga, 29010, Spain
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Seville, Sevilla, 41071, Spain
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Helsingborg, 25278, Sweden
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Stockholm, 182 88, Sweden
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Uppsala, 75185, Sweden
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Bern, Canton of Bern, 3010, Switzerland
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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
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Donetsk, 83003, Ukraine
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Kharkiv, 61068, Ukraine
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Kiev, 03110, Ukraine
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Lviv, 79000, Ukraine
Related Publications (1)
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.
PMID: 19729344DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 15, 2004
First Posted
December 16, 2004
Study Start
November 1, 2003
Study Completion
August 1, 2007
Last Updated
December 19, 2008
Record last verified: 2008-12