check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

91162

ClinicalTrials.gov Identifier:

NCT00099502

EudraCT Number:

Not Available

EU CT Number:

Not Available
BEYOND: Betaferon/Betaseron efficacy yielding outcomes of a new dose in Multiple Sclerosis (MS) Patients

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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 summary

Enrollment Goal
2244
Trial Dates
November 2003 - August 2007
Phase
Phase 3
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sanatorio BritanicoRosario, S2000CVB, Argentina
Completed
Queen Elizabeth II Health Sciences CentreHalifax, B3H 3A7, Canada
Completed
Aarhus UniversitetshospitalAarhus C, 8000, Denmark
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33521, Finland
Completed
Hopital Roger SalengroLille, 59037, France
Completed
Neurology Departmant of LatvianRiga, LV-1015, Latvia
Completed
Moskva City MS CenterMoskva, 127018, Russia
Completed
Danderyds sjukhusStockholm, 182 88, Sweden
Completed
City Clinical Hospital #4Kiev, 03110, Ukraine
Completed
University of California Davis Medical CenterSacramento, 95817, United States
Completed
Fundacion de NeurorehabilitacionRosario, S2000ZBL, Argentina
Completed
A. ö. Krankenhaus St. PöltenSt. Pölten, 3100, Austria
Completed
National Centrum voor MSMELSBROEK, 1820, Belgium
Completed
Faculdade de Ciencias Medicas-Universidade Estadual CampinasCampinas, 13081- 970, Brazil
Completed
LNK Wagner JaureggLinz, 4020, Austria
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
Universidade Federal de Sao Paulo - UNIFESPSao Paulo, 04039, Brazil
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Zala Megyei KorhazZalaegerszeg, 8900, Hungary
Completed
Beaumont HospitalDublin, 9, Ireland
Completed
Sourasky Medical CenterTel-Aviv, 64239, Israel
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
Multiple Sclerose Centrum NijmegenNIJMEGEN, 6533 PA, Netherlands
Completed
Haukeland University Hospital, BergenBergen, N-5021, Norway
Completed
SP Szpital Kliniczny nr 5Wroclaw, 50-417, Poland
Completed
Klinicni centerLjubljana, 1000, Slovenia
Completed
St. George Private Medical CentreKogarah, 2217, Australia
Completed
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Completed
Centre Hospitalier UniversitaireNimes, 30029, France
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17489, Germany
Completed
Oulun yliopistoOulu, Finland
Completed
A IKA General HospitalAthens, 15127, Greece
Completed
Petz Aladar Megyei KorhazGyör, 9024, Hungary
Completed
Akademiska SjukhusetUppsala, 75185, Sweden
Completed
Splosna Bolnisnica MaroborMaribor, 2000, Slovenia
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Gosford HospitalGosford, 2250, Australia
Completed
AHEPA University General Hospital of ThessalonikiThessaloniki, 546 36, Greece
Completed
Peterfy Sandor utcai Korhaz - RendelointezetBudapest, 1076, Hungary
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
Szpital im. N. BarlickiegoLodz, 90-153, Poland
Completed
PrivatlakarnaHelsingborg, 25278, Sweden
Completed
Institute of Neurology, Psychiatric and Narcology of AMSUKharkiv, 61068, Ukraine
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Hospital das Clínicas da Faculdade de Medicina da USPSao Paulo, 05403-900, Brazil
Completed
St Vincents University HospitalDublin, DUBLIN 4, Ireland
Completed
Carmel Medical CenterHaifa, 34362, Israel
Completed
Policlinico ConsorzialeBari, 70122, Italy
Completed
Orbis Medisch CentrumSITTARD, 6131 BK, Netherlands
Completed
II Klinika NeurologiiWarszawa, 02957, Poland
Completed
Institute of Neurology of Russian Academy of Medical ScienceMoskva, 123367, Russia
Completed
Donetsk state medical universityDonetsk, 83003, Ukraine
Completed
University of Chicago HospitalsChicago, 60637-1470, United States
Completed
Policlinica BancariaBuenos Aires, C1416CRJ, Argentina
Completed
Hospital Israelita Albert EinsteinSao Pulo, 05651-901, Brazil
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
Krankenhaus HennigsdorfHennigsdorf, 16761, Germany
Completed
Hospital Regional Carlos HayaMálaga, 29010, Spain
Completed
Hopital PontchaillouRennes, 35038, France
Completed
Cork University HospitalCork, Ireland
Completed
Hebrew University - Hadassah Medical SchoolJerusalem, 91120, Israel
Completed
Centre Hospitalier des Vallees de l'outaouaisHull, J8Y 1W7, Canada
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Completed
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbHHalle, 06120, Germany
Completed
G. Gennimatas General State Hospital of AthensAthens, 11527, Greece
Completed
Ospedale San Luigi GonzagaOrbassano, 10043, Italy
Completed
St. Petersburg Medical University n.a. PavlovSt. Petersburg, 197022, Russia
Completed
Fundacion FACENEBuenos Aires, C1117ABE, Argentina
Completed
Montreal Neurological HospitalMontreal, H3A 2B4, Canada
Completed
Rabin Medical CenterPetach Tikva, 49100, Israel
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
Sir Charles Gardiner HospitalNedlands, 6009, Australia
Completed
Hospital da RestauracaoRecife, 52010-040, Brazil
Completed
Health Science CentreWinnipeg, R3A 1R9, Canada
Completed
Uzsoki utkai KorhazBudapest, 1145, Hungary
Completed
Bnai Zion Medical CenterHaifa, 31048, Israel
Completed
1st Medical Academy Municipal Hospital N61Moscow, 119048, Russia
Completed
1st Pirogov Clinical HospitalMoscow, 117049, Russia
Completed
Neurology AssociatesTualatin, 97062, United States
Completed
Hospital BritánicoBuenos Aires, C1280AEB, Argentina
Completed
St Vincents HospitalMelbourne, 3065, Australia
Completed
Centre hospitalier universitairenancy, 54035, France
Completed
Borsod County HospitalMiskolc, 3526, Hungary
Completed
Misericordiae HospitalDublin, 7, Ireland
Completed
Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
Centralny Szpital Kliniczny AMWarszawa, 02-097, Poland
Completed
Regional Clinical HospitalLviv, 79000, Ukraine
Completed
University of Alabama at BirminghamBirmingham, 35294, United States
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Liverpool HospitalLiverpool, 2170, Australia
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Hopital generalDijon, 21033, France
Completed
Pecsi TE Neurologiai KlinikaPecs, 7623, Hungary
Completed
Adelaide & Meath HospitalDublin, Ireland
Completed
Jüdisches KrankenhausBerlin, 13347, Germany
Completed
CHRU Cote de NacreCAEN, F-14033, France
Completed
Barzili Medical CenterAshkelon, 78306, Israel
Completed
Siberian District Medical CenterNovosibirsk, 630007, Russia
Completed
Hosp. Univ. Clementino Fraga Filho - Univ. do Rio de JaneiroRio de Janeiro, 21949 900, Brazil
Completed
Bezirkskrankenhaus BayreuthBayreuth, 95445, Germany
Completed
C. H. U. Hopital PurpanToulouse, 31059, France
Completed
Assaf Harofeh Medical CenterZerifin, 70300, Israel
Completed
MONIKIMoskva, 129110, Russia
Completed
Blake NeurologyEnglewood, 80110, United States
Completed
University of British Columbia HospitalVancouver, V6T 2B5, Canada
Completed
Kamillus Klinik AsbachAsbach, 53567, Germany
Completed
Axiom Clinical ResearchTampa, 33609, United States
Completed
Universitäts-Krankenhaus EppendorfHamburg, 20251, Germany
Completed
Northwest NeuroSpecialists, PLLCTucson, 85741-3537, United States
Completed
Trilium Health CentreMississauga, L5B 1B8, Canada
Completed
Hopital gabriel montpiedClermont ferrand, 63003, France
Completed
Amphia Ziekenhuis, locatie LangendijkBREDA, 4819 EV, Netherlands
Completed
Wojewodzki Szpital Specjalistyczny im. M. KopernikaGdansk, 80-803, Poland
Completed
Institute of Brain of RussianSankt-Peterburg, 197376, Russia
Completed
University of KentuckyLexington, 40536, United States
Completed
Hospital Militar de CordobaCordoba, X5000HGX, Argentina
Completed
Inselspital BernBern, 3010, Switzerland
Completed
Städtisches Klinikum "St. Georg" LeipzigLeipzig, 04129, Germany
Completed
Centre hospitalier universitairenice, 06000, France
Completed
A.O. S.AndreaRoma, 00189, Italy
Completed
SP Szpital Kliniczny nr 2Poznan, 60-355, Poland
Completed
University of Nevada-RenoReno, 89557-0035, United States
Completed
Royal Melbourne HospitalParkville, 3050, Australia
Completed
Hospital das Clinicas da Universidade Federal do ParanáCuritiba, 80060-900, Brazil
Completed
Foothills Medical CentreCalgary, T2N 2T9, Canada
Completed
Katedra i Klinika Neurologii Sl.A.MKatowice, 40752, Poland
Completed
St. Mary's/Duluth Clinic Health SystemDuluth, 55805-1984, United States
Completed
Universitätsklinikum HeidelbergHeidelberg, 69112, Germany
Completed
East Bay Region Associates in NeurologyBerkeley, 94705, United States
Completed
Vivantes Klinikum SpandauBerlin, 13578, Germany
Completed
SUNY at Stony BrookStony Brook, 11794, United States
Completed
Universitätsklinikum MünsterMünster, 48149, Germany
Completed
Klinikum der Universität RegensburgRegensburg, 93053, Germany
Completed
University of Rochester Medical CenterRochester, 14642, United States
Completed
Klinikum OffenbachOffenbach, 63069, Germany
Completed
Alfried Krupp KrankenhausEssen, 45177, Germany
Completed
Neurological Associates of AlbanyAlbany, 12208, United States
Completed
Advanced Neurosciences InstituteNashville, 37205, United States
Completed
Dartmouth Hitchock Medical CenterLebanon, 03756-0001, United States
Completed
Wake Forest University Medical CenterWinston-Salem, 27157-1009, United States
Completed
Virginia Mason Medical CenterSeattle, 98101, United States
Completed
Thomas Jefferson UniversityPhiladelphia, 19107, United States
Completed
St. Michael's Hospital Health CentreToronto, M5C 2T2, Canada
Completed
Hospital de Clínicas de Porto AlegrePorto Alegre, Brazil
Completed
Klinikum der Philipps-UniversitätMarburg, 35043, Germany
Completed
Yaroslavl Medical AcademyYaroslavl, 150039, Russia
Completed
Washington University School of MedicineSt. Louis, 63110, United States
Completed
London Health Sciences CentreLondon, N6A 5A5, Canada
Completed
Klinikum der Justus-Liebig-UniversitätGießen, 35392, Germany
Completed
Hospital PellegrinBordeaux, 33076, France
Completed
City Hospital N 33Nizhny Novogorod, 603076, Russia
Completed
University of Medicine and Dentistry of New JerseyNew Brunswick, 08901, United States
Completed
Hopital Charles LeMoyneGreenfield Park, J4V 2H1, Canada
Completed
Centre René GauducheauNantes, 44805, France
Completed
Medical Military AcademySankt-Peterburg, 194044, Russia
Completed
Ottawa Headache Centre WestNepean, K2G 6E2, Canada
Completed
Hopital NeurologiqueLyon, 69003, France
Completed
Asklepios Klinik St. GeorgHamburg, 20099, Germany
Completed
University of Kansas Medical CenterKansas City, 66160, United States
Completed
George Washington UniversityWashington, 20037, United States
Completed
Integra Clinical Research, LLCSan Antonio, 78229, United States
Completed
North Central Neurology AssociatesCullman, 35058, United States
Completed
Louisiana State University Medical CenterShreveport, 71130, United States
Completed
University of Pittsburgh Medical Center Health SystemPittsburgh, 15213-2592, United States
Completed
Riverhills Healthcare, Inc.Cincinnati, 45219, United States
Completed
Coastal Neurological Medical GroupLa Jolla, 92037, United States
Completed
Ohio State University Medical CenterColumbus, 43210-1240, United States
Completed
Marshfield ClinicMarshfield, 54449, United States
Completed
Neurology Associates, PAWilmington, 19806, United States
Completed
High Point Neurological AssociatesHigh Point, 27262, United States
Completed
Medical University of South CarolinaCharleston, 29425, United States
Completed
Neurology Associates, PAWilmington, 19806, United States
Completed
Neurology & Neurosurgery Associates of Tacoma, Inc.Tacoma, 98405, United States
Completed
Tampa General HospitalTampa, 33606-3508, United States
Completed
Henry Ford Health SystemDetroit, 48202, United States
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
University of New MexicoAlbuquerque, 87131, United States
Completed
HenriettenstiftungHannover, 30171, Germany
Completed
University of California, San FranciscoSan Francisco, 94117, United States
Completed
Bereich Humanmed. d. Georg-August-Universität GöttingenGöttingen, 37075, Germany
Completed
Winthrop-University HospitalMineola, 11501-3987, United States
Completed
Fort Wayne Neurological CenterFort Wayne, 46805, United States
Completed
Mercy Ruan Neurology ClinicDes Moines, 50314, United States
Completed
Medical College of GAAugusta, 30912, United States
Completed
Duke University Medical CenterDurham, 27710, United States
Completed
Nevada Neurological Consultants, Ltd.Henderson, 89052, United States
Completed
Carolinas Medical CenterCharlotte, 28203, United States
Completed
St Lukes Medical CenterMilwaukee, 53215, United States
Completed
University Neurologists, PSCLouisville, 40202, United States
Completed
Hospital of the University of PennsylvaniaPhiladelphia, 19104, United States
Completed
Indiana UniversityIndianapolis, 46202, United States
Completed
Baylor CollegeHouston, 77030, United States
Completed
Neurology Foundation, Inc.Providence, 02905, United States
Completed
Neurology Center of Fairfax, Ltd.Fairfax, 22031, United States
Completed
University of MiamiMiami, 33125, United States
Completed
Shepherd CenterAtlanta, 30309-1465, United States
Completed
Barrow Neurology ClinicPhoenix, 85013, United States
Completed
Dr. Tamara Miller, MDFort Collins, 80528, United States

Primary Outcome

  • Hazard ratio for relapses
    date_rangeTime Frame:
    During the first and during the second 52 weeks
    enhanced_encryption
    Safety Issue:
    None

Secondary Outcome

  • Time to confirmed Expanded Disability Status Score (EDSS) progression
    date_rangeTime Frame:
    After 52 and after 104 weeks
    enhanced_encryption
    Safety Issue:
    None
  • Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images
    date_rangeTime Frame:
    After 104 weeks
    enhanced_encryption
    Safety Issue:
    None

Trial design

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, and2. Rater-blinded safety, tolerability, and efficacy of Betaseron/-Betaferon s.c. every other day with Copaxone 20 mg s.c. once daily.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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