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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-29

Study Completion Date

2018-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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)

Group Type OTHER

Brain MRI

Intervention Type OTHER

Brain MRI will be performed

Blood sampling

Intervention Type OTHER

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)

Group Type OTHER

Brain MRI

Intervention Type OTHER

Brain MRI will be performed

Blood sampling

Intervention Type OTHER

Blood samples will be taken

Interventions

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Brain MRI

Brain MRI will be performed

Intervention Type OTHER

Blood sampling

Blood samples will be taken

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Universität Graz

Graz, Styria, Austria

Site Status

Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, , Austria

Site Status

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

CHU de Liège

Liège, , Belgium

Site Status

Ottawa Hospital-General Campus

Ottawa, Ontario, Canada

Site Status

CHUM - Hopital Hotel-Dieu

Montreal, Quebec, Canada

Site Status

Montreal Neurological Hospital

Montreal, Quebec, Canada

Site Status

Fakultni nemocnice Brno

Brno, , Czechia

Site Status

Fakultni Nemocnice Hradec Kralove

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Ostrava

Ostrava-Poruba, , Czechia

Site Status

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Site Status

Amtssygehuset Glostrup

Glostrup Municipality, , Denmark

Site Status

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, , Finland

Site Status

Terveystalo Turku

Turku, , Finland

Site Status

Hôpital Pellegrin - Bordeaux

Bordeaux, , France

Site Status

Hopital general

Dijon, , France

Site Status

Hopital Roger Salengro

Lille, , France

Site Status

Hôpital Pasteur - Nice

Nice, , France

Site Status

Hôpital Pontchaillou

Rennes, , France

Site Status

Klinikum der Universität München Grosshadern

München, Bavaria, Germany

Site Status

Bezirksklinikum

Regensburg, Bavaria, Germany

Site Status

Krankenhaus Hennigsdorf

Hennigsdorf, Brandenburg, Germany

Site Status

Universitätsklinik Gießen und Marburg GmbH

Marburg, Hesse, Germany

Site Status

Sana Klinikum Offenbach GmbH

Offenbach, Hesse, Germany

Site Status

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Lower Saxony, Germany

Site Status

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Saxony-Anhalt, Germany

Site Status

HELIOS Klinikum Erfurt GmbH

Erfurt, Thuringia, Germany

Site Status

Universitätsklinikum Charite zu Berlin

Berlin, , Germany

Site Status

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, , Hungary

Site Status

Uzsoki Utcai Korhaz

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Site Status

Szent-Gyorgyi Albert Orvostudomanyi Egyetem

Szeged, , Hungary

Site Status

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, , Israel

Site Status

Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

IRCCS Ist Neurologico Nazionale C.Mondino

Pavia, Lombardy, Italy

Site Status

ASST Valle Olona

Varese, Lombardy, Italy

Site Status

A.O.U. San Luigi Gonzaga

Turin, Piedmont, Italy

Site Status

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

Torino, Tuscany, Italy

Site Status

Helse Bergen HF Haukeland universitetssjukehus

Bergen, , Norway

Site Status

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, , Poland

Site Status

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Site Status

Szpital im. N. Barlickiego

Lodz, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, , Poland

Site Status

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, , Poland

Site Status

Instituto Português de Oncologia Francisco Gentil - Coimbra

Coimbra, , Portugal

Site Status

Hospital Universitario Virgen de la Macarena

Seville, Andalusia, Spain

Site Status

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital Regional de Málaga

Málaga, , Spain

Site Status

Hospital Universitari i Politècnic La Fe

Valencia, , Spain

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Universitätsspital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Inselspital Universitätsspital Bern

Bern, , Switzerland

Site Status

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Countries

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Austria Belgium Canada Czechia Denmark Finland France Germany Hungary Israel Italy Norway Poland Portugal Spain Sweden Switzerland United Kingdom

Related Links

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https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

http://www.clinicaltrialsregister.eu/

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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