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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Brain MRI
Blood sampling
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medizinische Universität Graz
  • Landeskrankenhaus - Universitätskliniken Innsbruck
  • CU Saint-Luc/UZ St-Luc
  • UZ Gent
  • UZ Leuven Gasthuisberg
  • CHU de Liège
  • Ottawa Hospital-General Campus
  • CHUM - Hopital Hotel-Dieu
  • Montreal Neurological Hospital
  • Fakultni nemocnice Brno
  • Fakultni Nemocnice Hradec Kralove
  • Fakultni nemocnice Ostrava
  • Vseobecna fakultni nemocnice v Praze
  • Amtssygehuset Glostrup
  • Tampereen yliopistollinen sairaala, keskussairaala
  • Terveystalo Turku
  • Hôpital Pellegrin - Bordeaux
  • Hopital general
  • Hopital Roger Salengro
  • Hôpital Pasteur - Nice
  • Hôpital Pontchaillou
  • Klinikum der Universität München Grosshadern
  • Bezirksklinikum
  • Krankenhaus Hennigsdorf
  • Universitätsklinik Gießen und Marburg GmbH
  • Sana Klinikum Offenbach GmbH
  • Universitätsmedizin der Georg-August-Universität Göttingen
  • Heinrich-Heine-Universität Düsseldorf
  • Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
  • HELIOS Klinikum Erfurt GmbH
  • Universitätsklinikum Charite zu Berlin
  • Peterfy Sandor utcai Korhaz - Rendelointezet
  • Uzsoki Utcai Korhaz
  • Debreceni Egyetem Klinikai Kozpont
  • Szent-Gyorgyi Albert Orvostudomanyi Egyetem
  • Hadassah Hebrew University Hospital Ein Kerem
  • Ospedale San Raffaele
  • IRCCS Ist Neurologico Nazionale C.Mondino
  • ASST Valle Olona
  • A.O.U. San Luigi Gonzaga
  • A.O.U. Città della Salute e della Scienza di Torino
  • Helse Bergen HF Haukeland universitetssjukehus
  • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
  • Szpital Uniwersytecki w Krakowie
  • Szpital im. N. Barlickiego
  • Samodzielny Publiczny Szpital Kliniczny nr 4
  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • Instituto Português de Oncologia Francisco Gentil - Coimbra
  • Hospital Universitario Virgen de la Macarena
  • Ciutat Sanitària i Universitària de Bellvitge
  • Ciutat Sanitària i Universitaria de la Vall d'Hebron
  • Hospital Clínic i Provincial de Barcelona
  • Hospital Regional de Málaga
  • Hospital Universitari i Politècnic La Fe
  • Sahlgrenska Universitetssjukhuset
  • Universitätsspital Basel
  • Inselspital Universitätsspital Bern
  • Royal Hallamshire Hospital
  • Aberdeen Royal Infirmary
  • Ninewells Hospital
  • Charing Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Experimental arm 15 years ago

Placebo arm, offered treatment at MS diagnosis or at Month 24

Arm Description

This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symbol Digit Modalities Test score (SDMT score)
SDMT: Symbol Digit Modalities Test, Cognitive test For sustained attention, concentration and information processing speed
Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)
Relation of mental processing speed and MRI parameters
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
European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
Functional Assessment of Multiple Sclerosis (FAMS score)
FAMS: Functional Assessment of Multiple Sclerosis Questionnaire measuring health-related quality of life
Fatigue Scale for Motor and Cognitive Functions (FSMC score)
Center of Epidemiological Studies for Depression (CES-D) score
Time to second line therapy
Time to first disease-modifying therapies (DMT) other than IFNB-1b

Full Information

First Posted
August 9, 2017
Last Updated
May 14, 2019
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT03269175
Brief Title
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
Official Title
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
May 24, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm 15 years ago
Arm Type
Other
Arm Description
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Arm Title
Placebo arm, offered treatment at MS diagnosis or at Month 24
Arm Type
Other
Arm Description
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Intervention Type
Other
Intervention Name(s)
Brain MRI
Intervention Description
Brain MRI will be performed
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
Blood samples will be taken
Primary Outcome Measure Information:
Title
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
Title
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
Title
Time to first relapse
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to recurrent relapse
Time Frame
Over 15 years since the subject´s first clinical event
Title
Annualized relapse rate
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
Time Frame
Over 15 years since the subject´s first clinical event
Title
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
Title
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
Title
Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
Time Frame
Over 15 years since the subject´s first clinical event
Title
Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
Description
MSFC: Multiple Sclerosis Functional Composite
Time Frame
Over 15 years since the subject´s first clinical event
Title
Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to use of ambulatory device
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to dependence on ambulatory device
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to use of wheelchair
Time Frame
Over 15 years since the subject´s first clinical event
Title
Employment status (Standardized questions)
Description
The current employment will be recorded
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
Multiple sclerosis impact on employment
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
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
Title
Resource use assessment questions: Additional ambulatory services during relapse
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
Resource use assessment questions: Adaptions (past 6 months)
Time Frame
At one single visit, 15 years after the subject's first clinical event
Secondary Outcome Measure Information:
Title
Symbol Digit Modalities Test score (SDMT score)
Description
SDMT: Symbol Digit Modalities Test, Cognitive test For sustained attention, concentration and information processing speed
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
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
Title
Relation of mental processing speed and MRI parameters
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score
Description
EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
Time Frame
Over 15 years since the subject´s first clinical event
Title
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
Title
Functional Assessment of Multiple Sclerosis (FAMS score)
Description
FAMS: Functional Assessment of Multiple Sclerosis Questionnaire measuring health-related quality of life
Time Frame
Over 15 years since the subject´s first clinical event
Title
Fatigue Scale for Motor and Cognitive Functions (FSMC score)
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
Center of Epidemiological Studies for Depression (CES-D) score
Time Frame
At one single visit, 15 years after the subject's first clinical event
Title
Time to second line therapy
Time Frame
Over 15 years since the subject´s first clinical event
Title
Time to first disease-modifying therapies (DMT) other than IFNB-1b
Time Frame
Over 15 years since the subject´s first clinical event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus - Universitätskliniken Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
CU Saint-Luc/UZ St-Luc
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Ottawa Hospital-General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
CHUM - Hopital Hotel-Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Montreal Neurological Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
121 11
Country
Czechia
Facility Name
Amtssygehuset Glostrup
City
Glostrup
ZIP/Postal Code
DK-2600
Country
Denmark
Facility Name
Tampereen yliopistollinen sairaala, keskussairaala
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Terveystalo Turku
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Hôpital Pellegrin - Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hopital general
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Hopital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Pasteur - Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Klinikum der Universität München Grosshadern
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Bezirksklinikum
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Krankenhaus Hennigsdorf
City
Hennigsdorf
State/Province
Brandenburg
ZIP/Postal Code
16761
Country
Germany
Facility Name
Universitätsklinik Gießen und Marburg GmbH
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
Facility Name
Sana Klinikum Offenbach GmbH
City
Offenbach
State/Province
Hessen
ZIP/Postal Code
63069
Country
Germany
Facility Name
Universitätsmedizin der Georg-August-Universität Göttingen
City
Goettingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
HELIOS Klinikum Erfurt GmbH
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitätsklinikum Charite zu Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Peterfy Sandor utcai Korhaz - Rendelointezet
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Szent-Gyorgyi Albert Orvostudomanyi Egyetem
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Hadassah Hebrew University Hospital Ein Kerem
City
Jerusalem
Country
Israel
Facility Name
Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
IRCCS Ist Neurologico Nazionale C.Mondino
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
ASST Valle Olona
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21013
Country
Italy
Facility Name
A.O.U. San Luigi Gonzaga
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza di Torino
City
Torino
State/Province
Toscana
ZIP/Postal Code
10126
Country
Italy
Facility Name
Helse Bergen HF Haukeland universitetssjukehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
30-503
Country
Poland
Facility Name
Szpital im. N. Barlickiego
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Instituto Português de Oncologia Francisco Gentil - Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41071
Country
Spain
Facility Name
Ciutat Sanitària i Universitària de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Ciutat Sanitària i Universitaria de la Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Regional de Málaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Universitätsspital Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find results for studies related to Bayer products.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Learn more about this trial

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

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