BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
NCT ID: NCT03269175
Last Updated: 2019-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
261 participants
INTERVENTIONAL
2017-09-29
2018-05-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental arm 15 years ago
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Brain MRI
Brain MRI will be performed
Blood sampling
Blood samples will be taken
Placebo arm, offered treatment at MS diagnosis or at Month 24
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Brain MRI
Brain MRI will be performed
Blood sampling
Blood samples will be taken
Interventions
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Brain MRI
Brain MRI will be performed
Blood sampling
Blood samples will be taken
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Suspected clinical instability or unpredictability of the clinical course during the study(e.g., due to previous surgery or acute stroke)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Medizinische Universität Graz
Graz, Styria, Austria
Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, , Austria
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, , Belgium
UZ Gent
Ghent, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
CHUM - Hopital Hotel-Dieu
Montreal, Quebec, Canada
Montreal Neurological Hospital
Montreal, Quebec, Canada
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Amtssygehuset Glostrup
Glostrup Municipality, , Denmark
Tampereen yliopistollinen sairaala, keskussairaala
Tampere, , Finland
Terveystalo Turku
Turku, , Finland
Hôpital Pellegrin - Bordeaux
Bordeaux, , France
Hopital general
Dijon, , France
Hopital Roger Salengro
Lille, , France
Hôpital Pasteur - Nice
Nice, , France
Hôpital Pontchaillou
Rennes, , France
Klinikum der Universität München Grosshadern
München, Bavaria, Germany
Bezirksklinikum
Regensburg, Bavaria, Germany
Krankenhaus Hennigsdorf
Hennigsdorf, Brandenburg, Germany
Universitätsklinik Gießen und Marburg GmbH
Marburg, Hesse, Germany
Sana Klinikum Offenbach GmbH
Offenbach, Hesse, Germany
Universitätsmedizin der Georg-August-Universität Göttingen
Göttingen, Lower Saxony, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Saxony-Anhalt, Germany
HELIOS Klinikum Erfurt GmbH
Erfurt, Thuringia, Germany
Universitätsklinikum Charite zu Berlin
Berlin, , Germany
Peterfy Sandor utcai Korhaz - Rendelointezet
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Szent-Gyorgyi Albert Orvostudomanyi Egyetem
Szeged, , Hungary
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
Ospedale San Raffaele
Milan, Lombardy, Italy
IRCCS Ist Neurologico Nazionale C.Mondino
Pavia, Lombardy, Italy
ASST Valle Olona
Varese, Lombardy, Italy
A.O.U. San Luigi Gonzaga
Turin, Piedmont, Italy
A.O.U. Città della Salute e della Scienza di Torino
Torino, Tuscany, Italy
Helse Bergen HF Haukeland universitetssjukehus
Bergen, , Norway
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Bydgoszcz, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Szpital im. N. Barlickiego
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, , Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, , Poland
Instituto Português de Oncologia Francisco Gentil - Coimbra
Coimbra, , Portugal
Hospital Universitario Virgen de la Macarena
Seville, Andalusia, Spain
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, , Spain
Hospital Regional de Málaga
Málaga, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Universitätsspital Basel
Basel, Canton of Basel-City, Switzerland
Inselspital Universitätsspital Bern
Bern, , Switzerland
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
Countries
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Related Links
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Click here to find results for studies related to Bayer products.
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2017-001176-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19215
Identifier Type: -
Identifier Source: org_study_id
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