Trial Condition(s):

Multiple Sclerosis

Follow-up study after 11 years of patients who were included in the BENEFIT trial (304747) with a first demyelinating event suggestive of multiple sclerosis

Bayer Identifier:

16401

ClinicalTrials.gov Identifier:

NCT01795872

EudraCT Number:

2012-005262-35

Study Completed

Trial Purpose

This study assesses clinical and imaging long-term data,
after early or delayed interferon-beta-1b treatment in
patients with a first demyelinating event suggestive of
multiple sclerosis (MS), 11 years after enrollment in the
Betaferon/Betaseron in Newly Emerging Multiple
Sclerosis for Initial Treatment (BENEFIT) study
(304747).
The main objectives are to describe the disease course,
change in disability, cognitive function, resource use and
employment status, in relation to Interferon beta-1b in
the long term.

Inclusion Criteria
- Male and female patients with clinical-isolated syndrome or multiple sclerosis who have been treated at least once in BENEFIT Study 304747
Exclusion Criteria
- Patients who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the patient’s ability to understand the purpose of the study

Trial Summary

Enrollment Goal
278
Trial Dates
black-arrow
Phase
4
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

Universitätsklinikum Münster

Münster, Germany, 48149

Status
Terminated
 
Locations

Klinikum der Universität Würzburg

Würzburg, Germany, 97080

Status
Completed
 
Locations

Medizinische Einrichtungen der Heinrich-Heine-Universität

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Giessen und Marburg

Gießen, Germany, 35392

Status
Completed
 
Locations

Klinikum Offenbach

Offenbach, Germany, 63069

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

UZ Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Bezirksklinikum

Regensburg, Germany, 93053

Status
Completed
 
Locations

Klinikum der Ernst-Moritz-Arndt-Universität

Greifswald, Germany, 17475

Status
Completed
 
Locations

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Germany, 06120

Status
Completed
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Terminated
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35039

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55101

Status
Terminated
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50931

Status
Terminated
 
Locations

Krankenhaus Hennigsdorf

Hennigsdorf, Germany, 16761

Status
Completed
 
Locations

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
Locations

Hôpital Pontchaillou - Rennes CHU

Rennes, France, 35033

Status
Completed
 
Locations

Hôpital Pellegrin - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Hopital gabriel montpied

Clermont ferrand, France, 63003

Status
Completed
 
Locations

Hôpital Pasteur - Nice

NICE, France, 06200

Status
Completed
 
Locations

Hopital Roger Salengro - Lille

LILLE, France, 59037

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Completed
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85-681

Status
Completed
 
Locations

SP Szpital Kliniczny nr 5

Wroclaw, Poland, 50420

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 30-503

Status
Completed
 
Locations

IRCCS Ist Neurologico Nazionale C.Mondino

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Terminated
 
Locations

A.O. Sant'Antonio Abate

Gallarate, Italy, 21013

Status
Terminated
 
Locations

A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Completed
 
Locations

A.O. Città della Salute e della Scienza di Torino

Torino, Italy, 10126

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Terminated
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

CHUM - Hopital Notre-Dame

Montreal, Canada, H2L 4M1

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Amtssygehuset Glostrup

Glostrup, Denmark, DK-2600

Status
Completed
 
Locations

Helse Bergen HF Haukeland universitetssjukehus

Bergen, Norway, 5021

Status
Completed
 
Locations

Vseobecna fakultni nemocnice

Praha 2, Czech Republic, 121 11

Status
Completed
 
Locations

Faculty Hospital Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Fakultni nemocnice s poliklinikou Ostrava

Ostrava-Poruba, Czech Republic, 708 52

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 5262000

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel

Status
Terminated
 
Locations

Hospitais da Universidade de Coimbra

Coimbra, Portugal, 3030-075

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Terminated
 
Locations

Kantonsspital St. Gallen

St. Gallen, Switzerland, 9007

Status
Terminated
 
Locations

Oulun yliopisto

Oulu, Finland, 90029

Status
Completed
 
Locations

Terveystalo Turku

Turku, Finland, 20100

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37099

Status
Completed
 
Locations

Hopital general

Dijon, France, 21033

Status
Completed
 
Locations

Szpital im. N. Barlickiego

Lodz, Poland, 90-153

Status
Completed
 
Locations

IRCCS Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 5A5

Status
Completed
 
Locations

Foothills Medical Centre

Calgary, Canada, T2N 2T9

Status
Terminated
 
Locations

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, Hungary, 1076

Status
Completed
 
Locations

Uzsoki utkai Korhaz

Budapest, Hungary, 1145

Status
Completed
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4012

Status
Completed
 
Locations

Szent-Gyorgyi Albert Orvostudomanyi Egyetem

Szeged, Hungary, 6720

Status
Completed
 
Locations

Seinäjoen keskussairaala

Seinäjoki, Finland

Status
Terminated
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

Status
Completed
 
Locations

Klinicni center

Ljubljana, Slovenia, 1525

Status
Completed
 
Locations

C. H. U. Hopital Purpan

Toulouse, France, 31059

Status
Completed
 
Locations

Orbis Medisch Centrum

SITTARD, Netherlands, 6131 BK

Status
Terminated
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 

Trial Design