Trial Condition(s):

Multiple Sclerosis

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

Bayer Identifier:

19215

ClinicalTrials.gov Identifier:

NCT03269175

EudraCT Number:

2017-001176-31

Study Completed

Trial Purpose

The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study.
This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

Inclusion Criteria
-All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
Exclusion Criteria
-Subjects who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the subject’s ability to understand the purpose of the study
-Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)

Trial Summary

Enrollment Goal
261
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

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Universitätsklinikum Charite zu Berlin

Berlin, Germany, 10117

Status
Completed
 
Locations

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

HELIOS Klinikum Erfurt GmbH

Erfurt, Germany, 99089

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Charing Cross Hospital

London, United Kingdom

Status
Completed
 
Locations

Hôpital Pellegrin - Bordeaux

BORDEAUX, France, 33000

Status
Completed
 
Locations

Hopital general

Dijon, France, 21033

Status
Completed
 
Locations

Hopital Roger Salengro

LILLE, France, 59037

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 30-503

Status
Completed
 
Locations

Szpital im. N. Barlickiego

Lodz, Poland, 90-153

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Poland, 50-556

Status
Completed
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85-681

Status
Completed
 
Locations

ASST Valle Olona

Varese, Italy, 21013

Status
Completed
 
Locations

Hospital Regional de Málaga

Malaga, Spain, 29010

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Fakultni nemocnice Brno

Brno, Czech Republic, 625 00

Status
Completed
 
Locations

Fakultni Nemocnice Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Fakultni nemocnice Ostrava

Ostrava-Poruba, Czech Republic, 708 52

Status
Completed
 
Locations

Vseobecna fakultni nemocnice v Praze

Praha 2, Czech Republic, 121 11

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, Hungary, 1076

Status
Completed
 
Locations

Uzsoki Utcai Korhaz

Budapest, Hungary, 1145

Status
Completed
 
Locations

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4012

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Terveystalo Turku

Turku, Finland, 20100

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

CHUM - Hopital Hotel-Dieu

Montreal, Canada, H2X 0A9

Status
Completed
 
Locations

Montreal Neurological Hospital

Montreal, Canada, H3A 2B4

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Szent-Gyorgyi Albert Orvostudomanyi Egyetem

Szeged, Hungary, 6720

Status
Completed
 
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, 33521

Status
Completed
 
Locations

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Germany, 06120

Status
Completed
 
Locations

Krankenhaus Hennigsdorf

Hennigsdorf, Germany, 16761

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35043

Status
Completed
 
Locations

Klinikum der Universität München Grosshadern

München, Germany, 81377

Status
Completed
 
Locations

Sana Klinikum Offenbach GmbH

Offenbach, Germany, 63069

Status
Completed
 
Locations

Bezirksklinikum

Regensburg, Germany, 93053

Status
Completed
 
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
 
Locations

UZ Gent

Gent, Belgium, 9000

Status
Completed
 
Locations

Hôpital Pontchaillou

RENNES CEDEX, France, 35033

Status
Completed
 
Locations

Hôpital Pasteur - Nice

NICE, France, 06200

Status
Completed
 
Locations

Ninewells Hospital

Dundee, United Kingdom, DD1 9SY

Status
Completed
 
Locations

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, Poland, 20-090

Status
Completed
 
Locations

A.O.U. San Luigi Gonzaga

Torino, Italy, 10043

Status
Completed
 
Locations

Hospital Universitario Virgen de la Macarena

Sevilla, Spain, 41071

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Instituto Português de Oncologia Francisco Gentil - Coimbra

Coimbra, Portugal, 3000-075

Status
Completed
 
Locations

Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

IRCCS Ist Neurologico Nazionale C.Mondino

Pavia, Italy, 27100

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel

Status
Terminated
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Goettingen, Germany, 37075

Status
Completed
 
Locations

Helse Bergen HF Haukeland universitetssjukehus

Bergen, Norway, 5021

Status
Completed
 
Locations

Inselspital Universitätsspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

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

Torino, Italy, 10126

Status
Completed
 
Locations

Amtssygehuset Glostrup

Glostrup, Denmark, DK-2600

Status
Completed
 

Trial Design