Study Completed

Multiple sclerosis

Bayer Identifier:

91031

ClinicalTrials.gov Identifier:

NCT00185211

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial summary

Enrollment Goal

468

Trial Dates

August 2002 - May 2008

Phase

Phase 3

Could I Receive a placebo

Products

Betaseron (Interferon beta-1b, BAY86-5046)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Universitätsspital Basel	Basel, 4031, Switzerland
Completed	Hospitais da Universidade de Coimbra	Coimbra, 3000, Portugal
Completed	Fakultni nemocnice	Hradec Kralove, 50005, Czech Republic
Completed	Vivantes Klinikum Spandau	Berlin, 13585, Germany
Completed	Ciutat Sanitària i Universitària de Bellvitge	Hospitalet de Llobregat, 08907, Spain
Completed	Oulun yliopisto	Oulu, 90029, Finland
Completed	Hopital general	Dijon, 21033, France
Completed	Kantonsspital St. Gallen	St. Gallen, 9007, Switzerland
Completed	Fakultni nemocnice s poliklinikou Ostrava	Ostrava, 70852, Czech Republic
Completed	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Hopital Roger Salengro	Lille, 59037, France
Completed	Ottawa Hospital-General Campus	Ottawa, K1H 8L6, Canada
Completed	Neurolocicka klinika - MS centrum	Prag, 12808, Czech Republic
Completed	Hospital de Cruces	Barakaldo, 48903, Spain
Completed	Postitalon lääkäriasema	Helsinki, 00100, Finland
Completed	Jahn Ferenc Hospital	Budapest, 1204, Hungary
Completed	Medizinische Universität Graz	Graz, 8036, Austria
Completed	CU Saint-Luc/UZ St-Luc	Bruxelles, 1200, Belgium
Completed	Fakultni nemocnice Brno	Brno, 63900, Czech Republic
Completed	Krankenhaus Hennigsdorf	Hennigsdorf, 16761, Germany
Completed	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona, 08035, Spain
Completed	Suomen Erikoisneurologiakeskus Oy	Turku, 20100, Finland
Completed	Hospital Pellegrin	Bordeaux, 33076, France
Completed	Aberdeen Royal Infirmary	Aberdeen, AB25 2ZN, United Kingdom
Completed	Uzsoki utkai Korhaz	Budapest, 1145, Hungary
Completed	Haukeland universitetssjukehus, Bergen	Bergen, N-5021, Norway
Completed	Szpital Uniwersytecki w Krakowie	Krakow, 31503, Poland
Completed	Sahlgrenska Universitetssjukhuset	Göteborg, 41685, Sweden
Completed	Klinicni center	Lubljana, 1525, Slovenia
Completed	Universitätsklinikum Innsbruck	Innsbruck, 6020, Austria
Completed	Amtssygehuset Glostrup	Glostrup, 2600, Denmark
Completed	University of Debrecen Medical&Health Science Center	Debrecen, 4032, Hungary
Completed	Ospedale Sant'Antonio Abate	Gallarate, 21013, Italy
Completed	SP Szpital Kliniczny nr 5	Wroclaw, 50420, Poland
Completed	Fakultni nemocnice Kralovske Vinohrady	Prag, 10034, Czech Republic
Completed	Hospital Clínico Universitario San Carlos	Madrid, 28040, Spain
Completed	Peterfy Sandor utcai Korhaz - Rendelointezet	Budapest, 1076, Hungary
Completed	Kuopion yliopistollinen sairaala	Kuopio, 70210, Finland
Terminated	Centre hospitalier universitaire	nancy, 54035, France
Completed	St. Elisabeth Ziekenhuis	Tilburg, 5022 GC, Netherlands
Completed	UZ Gent	Gent, 9000, Belgium
Completed	Foothills Medical Centre	Calgary, T2N 2T9, Canada
Completed	Hospital Regional Carlos Haya	Malaga, 29010, Spain
Completed	C. H. U. Hopital Purpan	Toulouse, 31059, France
Completed	Medizinische Einrichtungen der Heinrich-Heine-Universität	Düsseldorf, 40225, Germany
Completed	Centre hospitalier universitaire	nice, 06000, France
Completed	Fondations rothshild	PARIS, 75019, France
Completed	Universitätsmedizin der Georg-August-Universität Göttingen	Göttingen, 37099, Germany
Completed	Carmel Medical Center	Haifa, 34362, Israel
Completed	Szpital im. N. Barlickiego	Lodz, 90153, Poland
Completed	Allgemeines Krankenhaus der Stadt Wien Universitätskliniken	Wien, 1090, Austria
Completed	UZ Leuven Gasthuisberg	Leuven, 3000, Belgium
Completed	CHUM - Hopital Notre-Dame	Montreal, H2L 4M1, Canada
Completed	Klinikum der Ernst-Moritz-Arndt-Universität	Greifswald, 17475, Germany
Completed	Seinäjoen keskussairaala	Seinäjoki, 60220, Finland
Completed	Charing Cross Hospital	London, W6 8RF, United Kingdom
Completed	Szeged University Medical School	Szeged, 6720, Hungary
Completed	Sheba Medical Center	Tel Hashomer, 52621, Israel
Completed	Samodzielny Publiczny Szpital Kliniczny nr 4	Lublin, 20090, Poland
Completed	CHU de Liège	Liège 1, 4000, Belgium
Completed	Charité Campus Benjamin Franklin	Berlin, 12200, Germany
Completed	HELIOS Klinikum Erfurt GmbH	Erfurt, 99089, Germany
Completed	Tampereen yliopistollinen sairaala, keskussairaala	Tampere, 33521, Finland
Completed	Ninewells Hospital and Medical School	Dundee, DD1 9SY, United Kingdom
Completed	Universitätskliniken des Saarlandes	Homburg, 66424, Germany
Completed	Johannes-Gutenberg-Universität Mainz	Mainz, 55101, Germany
Completed	LMU Klinikum der Universität München - Großhadern	München, 81377, Germany
Completed	Universitätsklinikum Regensburg	Regensburg, 93053, Germany
Completed	Universitätsklinikum Ulm	Ulm, 89081, Germany
Completed	Klinikum der Universität Würzburg	Würzburg, 97080, Germany
Completed	Klinikum Offenbach	Offenbach, 63069, Germany
Completed	Orbis Medisch Centrum	Sittard, 6131 BK, Netherlands
Completed	10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ	Bydgoszcz, 85681, Poland
Completed	Fakultni nemocnice Plzen	Plzen, 30460, Czech Republic
Completed	Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH	Halle, 06120, Germany
Completed	The Royal Hallamshire Hospital	Sheffield, S10 2JF, United Kingdom
Completed	University of British Columbia Hospital	Vancouver, V6T 2B5, Canada
Completed	Hospital Universitario Virgen de la Macarena	Sevilla, 41071, Spain
Completed	Hopital Pontchaillou	Rennes, 35038, France
Completed	Ospedale San Raffaele	Milano, 20132, Italy
Completed	London Health Sciences Centre	London, N6A 5A5, Canada
Completed	Städtisches Klinikum Braunschweig gGmbH	Braunschweig, 38126, Germany
Completed	Hospital Universitari i Politècnic La Fe	Valencia, 46026, Spain
Completed	St. Michael's Hospital Health Centre	Toronto, M5B 1W8, Canada
Completed	Hopital gabriel montpied	Clermont ferrand, 63003, France
Completed	A.O. di Padova	Padova, 35128, Italy
Completed	discontinued	Pavia, 27100, Italy
Completed	Universitätsklinikum Giessen und Marburg	Gießen, 35392, Germany
Completed	Università di Torino	Torino, 10126, Italy
Completed	Universitätsklinikum Köln	Köln, 50931, Germany
Completed	Otto-von-Guericke-Universität Magdeburg	Magdeburg, 39120, Germany
Completed	Universitätsklinik Gießen und Marburg GmbH	Marburg, 35039, Germany
Completed	Marien-Hospital	Düsseldorf, 40479, Germany
Completed	Universitätsklinikum Münster	Münster, 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
Time Frame:
up to 60 months after start of treatment
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
Time Frame:
up to 60 months after start of treatment
Safety Issue:
No
Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60
Time Frame:
60 months after start of treatment
Safety Issue:
No

Secondary Outcome

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

Additional Information

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