check_circleStudy Completed

Multiple sclerosis

BENEFIT study (Betaferon® / Betaseron® in newly emerging multiple sclerosis for initial treatment) and BENEFIT Follow-up Study

Trial purpose

This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

Key Participants Requirements

Sex

Both

Age

18 - 48 Years
  • - Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months
  • - No participation in the initial BENEFIT study

Trial summary

Enrollment Goal
468
Trial Dates
August 2002 - May 2008
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
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Hospitais da Universidade de CoimbraCoimbra, 3000, Portugal
Completed
Fakultni nemocniceHradec Kralove, 50005, Czech Republic
Completed
Vivantes Klinikum SpandauBerlin, 13585, Germany
Completed
Ciutat Sanitària i Universitària de BellvitgeHospitalet de Llobregat, 08907, Spain
Completed
Oulun yliopistoOulu, 90029, Finland
Completed
Hopital generalDijon, 21033, France
Completed
Kantonsspital St. GallenSt. Gallen, 9007, Switzerland
Completed
Fakultni nemocnice s poliklinikou OstravaOstrava, 70852, Czech Republic
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Hopital Roger SalengroLille, 59037, France
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
Neurolocicka klinika - MS centrumPrag, 12808, Czech Republic
Completed
Hospital de CrucesBarakaldo, 48903, Spain
Completed
Postitalon lääkäriasemaHelsinki, 00100, Finland
Completed
Jahn Ferenc HospitalBudapest, 1204, Hungary
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
CU Saint-Luc/UZ St-LucBruxelles, 1200, Belgium
Completed
Fakultni nemocnice BrnoBrno, 63900, Czech Republic
Completed
Krankenhaus HennigsdorfHennigsdorf, 16761, Germany
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Suomen Erikoisneurologiakeskus OyTurku, 20100, Finland
Completed
Hospital PellegrinBordeaux, 33076, France
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Uzsoki utkai KorhazBudapest, 1145, Hungary
Completed
Haukeland universitetssjukehus, BergenBergen, N-5021, Norway
Completed
Szpital Uniwersytecki w KrakowieKrakow, 31503, Poland
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 41685, Sweden
Completed
Klinicni centerLubljana, 1525, Slovenia
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
Amtssygehuset GlostrupGlostrup, 2600, Denmark
Completed
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Completed
Ospedale Sant'Antonio AbateGallarate, 21013, Italy
Completed
SP Szpital Kliniczny nr 5Wroclaw, 50420, Poland
Completed
Fakultni nemocnice Kralovske VinohradyPrag, 10034, Czech Republic
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Peterfy Sandor utcai Korhaz - RendelointezetBudapest, 1076, Hungary
Completed
Kuopion yliopistollinen sairaalaKuopio, 70210, Finland
Terminated
Centre hospitalier universitairenancy, 54035, France
Completed
St. Elisabeth ZiekenhuisTilburg, 5022 GC, Netherlands
Completed
UZ GentGent, 9000, Belgium
Completed
Foothills Medical CentreCalgary, T2N 2T9, Canada
Completed
Hospital Regional Carlos HayaMalaga, 29010, Spain
Completed
C. H. U. Hopital PurpanToulouse, 31059, France
Completed
Medizinische Einrichtungen der Heinrich-Heine-UniversitätDüsseldorf, 40225, Germany
Completed
Centre hospitalier universitairenice, 06000, France
Completed
Fondations rothshildPARIS, 75019, France
Completed
Universitätsmedizin der Georg-August-Universität GöttingenGöttingen, 37099, Germany
Completed
Carmel Medical CenterHaifa, 34362, Israel
Completed
Szpital im. N. BarlickiegoLodz, 90153, Poland
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
UZ Leuven GasthuisbergLeuven, 3000, Belgium
Completed
CHUM - Hopital Notre-DameMontreal, H2L 4M1, Canada
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17475, Germany
Completed
Seinäjoen keskussairaalaSeinäjoki, 60220, Finland
Completed
Charing Cross HospitalLondon, W6 8RF, United Kingdom
Completed
Szeged University Medical SchoolSzeged, 6720, Hungary
Completed
Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20090, Poland
Completed
CHU de LiègeLiège 1, 4000, Belgium
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33521, Finland
Completed
Ninewells Hospital and Medical SchoolDundee, DD1 9SY, United Kingdom
Completed
Universitätskliniken des SaarlandesHomburg, 66424, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55101, Germany
Completed
LMU Klinikum der Universität München - GroßhadernMünchen, 81377, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Completed
Universitätsklinikum UlmUlm, 89081, Germany
Completed
Klinikum der Universität WürzburgWürzburg, 97080, Germany
Completed
Klinikum OffenbachOffenbach, 63069, Germany
Completed
Orbis Medisch CentrumSittard, 6131 BK, Netherlands
Completed
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZBydgoszcz, 85681, Poland
Completed
Fakultni nemocnice PlzenPlzen, 30460, Czech Republic
Completed
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbHHalle, 06120, Germany
Completed
The Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Completed
University of British Columbia HospitalVancouver, V6T 2B5, Canada
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Completed
Hopital PontchaillouRennes, 35038, France
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
London Health Sciences CentreLondon, N6A 5A5, Canada
Completed
Städtisches Klinikum Braunschweig gGmbHBraunschweig, 38126, Germany
Completed
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
St. Michael's Hospital Health CentreToronto, M5B 1W8, Canada
Completed
Hopital gabriel montpiedClermont ferrand, 63003, France
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
discontinuedPavia, 27100, Italy
Completed
Universitätsklinikum Giessen und MarburgGießen, 35392, Germany
Completed
Università di TorinoTorino, 10126, Italy
Completed
Universitätsklinikum KölnKöln, 50931, Germany
Completed
Otto-von-Guericke-Universität MagdeburgMagdeburg, 39120, Germany
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35039, Germany
Completed
Marien-HospitalDüsseldorf, 40479, Germany
Completed
Universitätsklinikum MünsterMünster, 48149, Germany

Primary Outcome

  • Time to Clinically Definite Multiple Sclerosis (CDMS) represented by Kaplan-Meier estimates of the cumulative percentage of participants with CDMS at selected points in time
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60
    date_rangeTime Frame:
    60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60
    date_rangeTime Frame:
    60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60
    date_rangeTime Frame:
    up to 60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60
    date_rangeTime Frame:
    60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60
    date_rangeTime Frame:
    60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No
  • MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60
    date_rangeTime Frame:
    60 months after start of treatment
    enhanced_encryption
    Safety Issue:
    No

Trial design

Open-label, multi-center phase III extension of the double-blind, placebo-controlled BENEFIT study (no. 92012/304747) to obtain long-term follow-up data of patients with clinically definite multiple sclerosis (MS) and patients with a first demyelinating event suggestive of MS treated with 8 MIU (250 µg) interferon beta-1b (Betaferon® / Betaseron®) given subcutaneously every other day for at least 36 months.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2