check_circleStudy Completed

Multiple Sclerosis

Bayer Identifier:

19215

ClinicalTrials.gov Identifier:

NCT03269175

EudraCT Number:

2017-001176-31

EU CT Number:

Not Available
BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • -All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
  • -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
September 2017 - May 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Universitätsklinikum Charite zu BerlinBerlin, 10117, Germany
Completed
Heinrich-Heine-Universität DüsseldorfDüsseldorf, 40225, Germany
Completed
HELIOS Klinikum Erfurt GmbHErfurt, 99089, Germany
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Charing Cross HospitalLondon, United Kingdom
Completed
Hôpital Pellegrin - BordeauxBORDEAUX, 33000, France
Completed
Hopital generalDijon, 21033, France
Completed
Hopital Roger SalengroLILLE, 59037, France
Completed
Szpital Uniwersytecki w KrakowieKrakow, 30-503, Poland
Completed
Szpital im. N. BarlickiegoLodz, 90-153, Poland
Completed
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-RadeckiegoWroclaw, 50-556, Poland
Completed
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZBydgoszcz, 85-681, Poland
Completed
ASST Valle OlonaVarese, 21013, Italy
Completed
Ciutat Sanitària i Universitaria de la Vall d'HebronBarcelona, 08035, Spain
Completed
Hospital Regional de MálagaMalaga, 29010, Spain
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Fakultni nemocnice BrnoBrno, 625 00, Czech Republic
Completed
Fakultni Nemocnice Hradec KraloveHradec Kralove, 500 05, Czech Republic
Completed
Fakultni nemocnice OstravaOstrava-Poruba, 708 52, Czech Republic
Completed
Vseobecna fakultni nemocnice v PrazePraha 2, 121 11, Czech Republic
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Landeskrankenhaus - Universitätskliniken InnsbruckInnsbruck, 6020, Austria
Completed
Peterfy Sandor utcai Korhaz - RendelointezetBudapest, 1076, Hungary
Completed
Uzsoki Utcai KorhazBudapest, 1145, Hungary
Completed
Debreceni Egyetem Klinikai KozpontDebrecen, 4012, Hungary
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Terveystalo TurkuTurku, 20100, Finland
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
CHUM - Hopital Hotel-DieuMontreal, H2X 0A9, Canada
Completed
Montreal Neurological HospitalMontreal, H3A 2B4, Canada
Completed
Ottawa Hospital-General CampusOttawa, K1H 8L6, Canada
Completed
Szent-Gyorgyi Albert Orvostudomanyi EgyetemSzeged, 6720, Hungary
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, 33521, Finland
Completed
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbHHalle, 06120, Germany
Completed
Krankenhaus HennigsdorfHennigsdorf, 16761, Germany
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35043, Germany
Completed
Klinikum der Universität München GrosshadernMünchen, 81377, Germany
Completed
Sana Klinikum Offenbach GmbHOffenbach, 63069, Germany
Completed
BezirksklinikumRegensburg, 93053, Germany
Withdrawn
Universitätsklinikum EssenEssen, 45147, Germany
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
UZ GentGent, 9000, Belgium
Completed
Hôpital PontchaillouRENNES CEDEX, 35033, France
Withdrawn
C. H. U. Hopital PurpanToulouse, 31059, France
Completed
Hôpital Pasteur - NiceNICE, 06200, France
Completed
Ninewells HospitalDundee, DD1 9SY, United Kingdom
Completed
Royal Hallamshire HospitalSheffield, S10 2JF, United Kingdom
Completed
Samodzielny Publiczny Szpital Kliniczny nr 4Lublin, 20-090, Poland
Completed
A.O.U. San Luigi GonzagaTorino, 10043, Italy
Completed
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Completed
Hospital Universitari i Politècnic La FeValencia, 46026, Spain
Completed
Instituto Português de Oncologia Francisco Gentil - CoimbraCoimbra, 3000-075, Portugal
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
IRCCS Ist Neurologico Nazionale C.MondinoPavia, 27100, Italy
Terminated
Hadassah Hebrew University Hospital Ein KeremJerusalem, Israel
Completed
Universitätsmedizin der Georg-August-Universität GöttingenGoettingen, 37075, Germany
Completed
Helse Bergen HF Haukeland universitetssjukehusBergen, 5021, Norway
Completed
Inselspital Universitätsspital BernBern, 3010, Switzerland
Completed
A.O.U. Città della Salute e della Scienza di TorinoTorino, 10126, Italy
Completed
Amtssygehuset GlostrupGlostrup, DK-2600, Denmark

Primary Outcome

  • Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
    date_rangeTime Frame:
    Over 15 years since the subject`s first clinical event
  • Time to first relapse
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to recurrent relapse
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Annualized relapse rate
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination
    date_rangeTime Frame:
    15 years after the subject´s first clinical event
  • Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
    MSFC: Multiple Sclerosis Functional Composite
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to use of ambulatory device
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to dependence on ambulatory device
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to use of wheelchair
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Employment status (Standardized questions)
    The current employment will be recorded
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Multiple sclerosis impact on employment
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Resource use assessment questions: Help from family/regular ambulatory services
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Resource use assessment questions: Additional ambulatory services during relapse
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Resource use assessment questions: Adaptions (past 6 months)
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event

Secondary Outcome

  • Symbol Digit Modalities Test score (SDMT score)
    SDMT: Symbol Digit Modalities Test, Cognitive test For sustained attention, concentration and information processing speed
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Relation of mental processing speed and MRI parameters
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • European Quality of life – 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score
    EQ-5D: European Quality of Life – 5 dimensions Questionnaire measuring health-related quality of life
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
    date_rangeTime Frame:
    Over 15 years since the subject`s first clinical event
  • Functional Assessment of Multiple Sclerosis (FAMS score)
    FAMS: Functional Assessment of Multiple Sclerosis Questionnaire measuring health-related quality of life
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Fatigue Scale for Motor and Cognitive Functions (FSMC score)
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Center of Epidemiological Studies for Depression (CES-D) score
    date_rangeTime Frame:
    At one single visit, 15 years after the subject’s first clinical event
  • Time to second line therapy
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event
  • Time to first disease-modifying therapies (DMT) other than IFNB-1b
    date_rangeTime Frame:
    Over 15 years since the subject´s first clinical event

Trial design

BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
Trial Type
Interventional
Intervention Type
Other
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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