Trial Condition(s):

Multiple Sclerosis

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

Bayer Identifier:

91031

ClinicalTrials.gov Identifier:

NCT00185211

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS  or by completing 24 months
Exclusion Criteria
- No participation in the initial BENEFIT study

Trial Summary

Enrollment Goal
468
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3000

Status
Completed
 
Locations

Fakultni nemocnice

Hradec Kralove, Czech Republic, 50005

Status
Completed
 
Locations

Vivantes Klinikum Spandau

Berlin, Germany, 13585

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Oulun yliopisto

Oulu, Finland, 90029

Status
Completed
 
Locations

Hopital general

Dijon, France, 21033

Status
Completed
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Completed
 
Locations

Fakultni nemocnice s poliklinikou Ostrava

Ostrava, Czech Republic, 70852

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hopital Roger Salengro

Lille, France, 59037

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Neurolocicka klinika - MS centrum

Prag, Czech Republic, 12808

Status
Completed
 
Locations

Hospital de Cruces

Barakaldo, Spain, 48903

Status
Completed
 
Locations

Postitalon lääkäriasema

Helsinki, Finland, 00100

Status
Completed
 
Locations

Jahn Ferenc Hospital

Budapest, Hungary, 1204

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

Bruxelles, Belgium, 1200

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 63900

Status
Completed
 
Locations

Krankenhaus Hennigsdorf

Hennigsdorf, Germany, 16761

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Suomen Erikoisneurologiakeskus Oy

Turku, Finland, 20100

Status
Completed
 
Locations

Hospital Pellegrin

Bordeaux, France, 33076

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Uzsoki utkai Korhaz

Budapest, Hungary, 1145

Status
Completed
 
Locations

Haukeland universitetssjukehus, Bergen

Bergen, Norway, N-5021

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31503

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 41685

Status
Completed
 
Locations

Klinicni center

Lubljana, Slovenia, 1525

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Amtssygehuset Glostrup

Glostrup, Denmark, 2600

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Ospedale Sant'Antonio Abate

Gallarate, Italy, 21013

Status
Completed
 
Locations

SP Szpital Kliniczny nr 5

Wroclaw, Poland, 50420

Status
Completed
 
Locations

Fakultni nemocnice Kralovske Vinohrady

Prag, Czech Republic, 10034

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, Hungary, 1076

Status
Completed
 
Locations

Kuopion yliopistollinen sairaala

Kuopio, Finland, 70210

Status
Completed
 
Locations

Centre hospitalier universitaire

nancy, France, 54035

Status
Terminated
 
Locations

St. Elisabeth Ziekenhuis

Tilburg, Netherlands, 5022 GC

Status
Completed
 
Locations

UZ Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Foothills Medical Centre

Calgary, Canada, T2N 2T9

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Malaga, Spain, 29010

Status
Completed
 
Locations

C. H. U. Hopital Purpan

Toulouse, France, 31059

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Centre hospitalier universitaire

nice, France, 06000

Status
Completed
 
Locations

Fondations rothshild

PARIS, France, 75019

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37099

Status
Completed
 
Locations

Carmel Medical Center

Haifa, Israel, 34362

Status
Completed
 
Locations

Szpital im. N. Barlickiego

Lodz, Poland, 90153

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

Leuven, Belgium, 3000

Status
Completed
 
Locations

CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17475

Status
Completed
 
Locations

Seinäjoen keskussairaala

Seinäjoki, Finland, 60220

Status
Completed
 
Locations

Charing Cross Hospital

London, United Kingdom, W6 8RF

Status
Completed
 
Locations

Szeged University Medical School

Szeged, Hungary, 6720

Status
Completed
 
Locations

Sheba Medical Center

Tel Hashomer, Israel, 52621

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20090

Status
Completed
 
Locations

CHU de Liège

Liège 1, Belgium, 4000

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

Status
Completed
 
Locations

Ninewells Hospital and Medical School

Dundee, United Kingdom, DD1 9SY

Status
Completed
 
Locations

Universitätskliniken des Saarlandes

Homburg, Germany, 66424

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55101

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89081

Status
Completed
 
Locations

Klinikum der Universität Würzburg

Würzburg, Germany, 97080

Status
Completed
 
Locations

Klinikum Offenbach

Offenbach, Germany, 63069

Status
Completed
 
Locations

Orbis Medisch Centrum

Sittard, Netherlands, 6131 BK

Status
Completed
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85681

Status
Completed
 
Locations

Fakultni nemocnice Plzen

Plzen, Czech Republic, 30460

Status
Completed
 
Locations

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Germany, 06120

Status
Completed
 
Locations

The Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
Locations

University of British Columbia Hospital

Vancouver, Canada, V6T 2B5

Status
Completed
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

Status
Completed
 
Locations

Hopital Pontchaillou

Rennes, France, 35038

Status
Completed
 
Locations

Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

Städtisches Klinikum Braunschweig gGmbH

Braunschweig, Germany, 38126

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

St. Michael's Hospital Health Centre

Toronto, Canada, M5B 1W8

Status
Completed
 
Locations

Hopital gabriel montpied

Clermont ferrand, France, 63003

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

discontinued

Pavia, Italy, 27100

Status
Completed
 
Locations

Universitätsklinikum Giessen und Marburg

Gießen, Germany, 35392

Status
Completed
 
Locations

Università di Torino

Torino, Italy, 10126

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50931

Status
Completed
 
Locations

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39120

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35039

Status
Completed
 
Locations

Marien-Hospital

Düsseldorf, Germany, 40479

Status
Completed
 
Locations

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Completed
 

Trial Design