BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

May 14, 2019 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Landeskrankenhaus - Universitätskliniken Innsbruck
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universitat Graz
  • Belgium
      • Bruxelles - Brussel, Belgium, 1200
        • CU Saint-Luc/UZ St-Luc
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Liege, Belgium, 4000
        • CHU de Liège
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital-General Campus
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Hospital
      • Montreal, Quebec, Canada, H2X 0A9
        • CHUM - Hopital Hotel-Dieu
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Praha 2, Czechia, 121 11
        • Vseobecna fakultni nemocnice v Praze
  • Denmark
      • Glostrup, Denmark, DK-2600
        • Amtssygehuset Glostrup
  • Finland
      • Tampere, Finland, 33521
        • Tampereen yliopistollinen sairaala, keskussairaala
      • Turku, Finland, 20100
        • Terveystalo Turku
  • France
      • Bordeaux, France, 33000
        • Hôpital Pellegrin - Bordeaux
      • Dijon, France, 21033
        • Hôpital Général
      • Lille, France, 59037
        • Hôpital Roger Salengro
      • Nice, France, 06200
        • Hôpital Pasteur - Nice
      • Rennes Cedex, France, 35033
        • Hopital Pontchaillou
  • Germany
      • Berlin, Germany, 10117
        • Universitätsklinikum Charite zu Berlin
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinikum der Universität München Großhadern
      • Regensburg, Bayern, Germany, 93053
        • Bezirksklinikum
    • Brandenburg
      • Hennigsdorf, Brandenburg, Germany, 16761
        • Krankenhaus Hennigsdorf
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinik Gießen und Marburg GmbH
      • Offenbach, Hessen, Germany, 63069
        • Sana Klinikum Offenbach GmbH
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Universitätsmedizin der Georg-August-Universität Göttingen
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Heinrich-Heine-Universität Düsseldorf
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
        • Helios Klinikum Erfurt GmbH
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1076
        • Peterfy Sandor utcai Korhaz - Rendelointezet
      • Debrecen, Hungary, 4012
        • Debreceni Egyetem Klinikai Kozpont
      • Szeged, Hungary, 6720
        • Szent-Gyorgyi Albert Orvostudomanyi Egyetem
  • Israel
      • Jerusalem, Israel
        • Hadassah Hebrew University Hospital Ein Kerem
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele
      • Pavia, Lombardia, Italy, 27100
        • IRCCS Ist Neurologico Nazionale C.Mondino
      • Varese, Lombardia, Italy, 21013
        • ASST Valle Olona
    • Piemonte
      • Torino, Piemonte, Italy, 10043
        • A.O.U. San Luigi Gonzaga
    • Toscana
      • Torino, Toscana, Italy, 10126
        • A.O.U. Città della Salute e Della Scienza di Torino
  • Norway
      • Bergen, Norway, 5021
        • Helse Bergen HF Haukeland Universitetssjukehus
  • Poland
      • Bydgoszcz, Poland, 85-681
        • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
      • Krakow, Poland, 30-503
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 90-153
        • Szpital im. N. Barlickiego
      • Lublin, Poland, 20-090
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Instituto Português de Oncologia Francisco Gentil - Coimbra
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
      • Malaga, Spain, 29010
        • Hospital Regional de Malaga
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Andalucía
      • Sevilla, Andalucía, Spain, 41071
        • Hospital Universitario Virgen de la Macarena
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Ciutat Sanitaria i Universitaria de Bellvitge
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
  • Switzerland
      • Bern, Switzerland, 3010
        • INSELSPITAL Universitätsspital Bern
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitatsspital Basel
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • London, United Kingdom
        • Charing Cross Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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)
Other: Brain MRI
Brain MRI will be performed
Other: Blood sampling
Blood samples will be taken
Other: 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)
Other: Brain MRI
Brain MRI will be performed
Other: Blood sampling
Blood samples will be taken

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symbol Digit Modalities Test score (SDMT score)
Time Frame: At one single visit, 15 years after the subject's first clinical event

SDMT: Symbol Digit Modalities Test, Cognitive test

For sustained attention, concentration and information processing speed
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)
Time Frame: At one single visit, 15 years after the subject's first clinical event
At one single visit, 15 years after the subject's first clinical event
Relation of mental processing speed and MRI parameters
Time Frame: At one single visit, 15 years after the subject's first clinical event
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
Time Frame: Over 15 years since the subject´s first clinical event
EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
Over 15 years since the subject´s first clinical event
European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
Time Frame: Over 15 years since the subject's first clinical event
Over 15 years since the subject's first clinical event
Functional Assessment of Multiple Sclerosis (FAMS score)
Time Frame: Over 15 years since the subject´s first clinical event

FAMS: Functional Assessment of Multiple Sclerosis

Questionnaire measuring health-related quality of life
Over 15 years since the subject´s first clinical event
Fatigue Scale for Motor and Cognitive Functions (FSMC score)
Time Frame: At one single visit, 15 years after the subject's first clinical event
At one single visit, 15 years after the subject's first clinical event
Center of Epidemiological Studies for Depression (CES-D) score
Time Frame: At one single visit, 15 years after the subject's first clinical event
At one single visit, 15 years after the subject's first clinical event
Time to second line therapy
Time Frame: Over 15 years since the subject´s first clinical event
Over 15 years since the subject´s first clinical event
Time to first disease-modifying therapies (DMT) other than IFNB-1b
Time Frame: Over 15 years since the subject´s first clinical event
Over 15 years since the subject´s first clinical event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2017

Primary Completion (Actual)

May 24, 2018

Study Completion (Actual)

May 24, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19215
  • 2017-001176-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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