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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269175
• Other study ID #: 19215
• Secondary ID: 2017-001176-31
• Status: Completed
• Phase: Phase 4
• Start date: September 29, 2017
• Est. completion date: May 24, 2018

Study information

• Verified date: May 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: May 24, 2018
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Brain MRI
Brain MRI will be performed
• Blood sampling
Blood samples will be taken

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Landeskrankenhaus - Universitätskliniken Innsbruck	Innsbruck
Belgium	CU Saint-Luc/UZ St-Luc	Bruxelles - Brussel
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	CHU de Liège	Liege
Canada	CHUM - Hopital Hotel-Dieu	Montreal	Quebec
Canada	Montreal Neurological Hospital	Montreal	Quebec
Canada	Ottawa Hospital-General Campus	Ottawa	Ontario
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni Nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Denmark	Amtssygehuset Glostrup	Glostrup
Finland	Tampereen yliopistollinen sairaala, keskussairaala	Tampere
Finland	Terveystalo Turku	Turku
France	Hôpital Pellegrin - Bordeaux	Bordeaux
France	Hopital general	Dijon
France	Hopital Roger Salengro	Lille
France	Hôpital Pasteur - Nice	Nice
France	Hôpital Pontchaillou	Rennes Cedex
Germany	Universitätsklinikum Charite zu Berlin	Berlin
Germany	Heinrich-Heine-Universität Düsseldorf	Düsseldorf	Nordrhein-Westfalen
Germany	HELIOS Klinikum Erfurt GmbH	Erfurt	Thüringen
Germany	Universitätsmedizin der Georg-August-Universität Göttingen	Goettingen	Niedersachsen
Germany	Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH	Halle	Sachsen-Anhalt
Germany	Krankenhaus Hennigsdorf	Hennigsdorf	Brandenburg
Germany	Universitätsklinik Gießen und Marburg GmbH	Marburg	Hessen
Germany	Klinikum der Universität München Grosshadern	München	Bayern
Germany	Sana Klinikum Offenbach GmbH	Offenbach	Hessen
Germany	Bezirksklinikum	Regensburg	Bayern
Hungary	Peterfy Sandor utcai Korhaz - Rendelointezet	Budapest
Hungary	Uzsoki Utcai Korhaz	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Szent-Gyorgyi Albert Orvostudomanyi Egyetem	Szeged
Israel	Hadassah Hebrew University Hospital Ein Kerem	Jerusalem
Italy	Ospedale San Raffaele	Milano	Lombardia
Italy	IRCCS Ist Neurologico Nazionale C.Mondino	Pavia	Lombardia
Italy	A.O.U. Città della Salute e della Scienza di Torino	Torino	Toscana
Italy	A.O.U. San Luigi Gonzaga	Torino	Piemonte
Italy	ASST Valle Olona	Varese	Lombardia
Norway	Helse Bergen HF Haukeland universitetssjukehus	Bergen
Poland	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
Portugal	Instituto Português de Oncologia Francisco Gentil - Coimbra	Coimbra
Spain	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Ciutat Sanitària i Universitària de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Regional de Málaga	Malaga
Spain	Hospital Universitario Virgen de la Macarena	Sevilla	Andalucía
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Switzerland	Universitätsspital Basel	Basel	Basel-Stadt
Switzerland	Inselspital Universitätsspital Bern	Bern
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Charing Cross Hospital	London
United Kingdom	Royal Hallamshire Hospital	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria		Over 15 years since the subject´s first clinical event
Primary	Disease course since start of BENEFIT as assessed at the time of BENEFIT 15		Over 15 years since the subject`s first clinical event
Primary	Time to first relapse		Over 15 years since the subject´s first clinical event
Primary	Time to recurrent relapse		Over 15 years since the subject´s first clinical event
Primary	Annualized relapse rate		Over 15 years since the subject´s first clinical event
Primary	Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)		Over 15 years since the subject´s first clinical event
Primary	Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)		Over 15 years since the subject´s first clinical event
Primary	Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination		15 years after the subject´s first clinical event
Primary	Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)		Over 15 years since the subject´s first clinical event
Primary	Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)		Over 15 years since the subject´s first clinical event
Primary	Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)	MSFC: Multiple Sclerosis Functional Composite	Over 15 years since the subject´s first clinical event
Primary	Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)		Over 15 years since the subject´s first clinical event
Primary	Time to use of ambulatory device		Over 15 years since the subject´s first clinical event
Primary	Time to dependence on ambulatory device		Over 15 years since the subject´s first clinical event
Primary	Time to use of wheelchair		Over 15 years since the subject´s first clinical event
Primary	Employment status (Standardized questions)	The current employment will be recorded	At one single visit, 15 years after the subject's first clinical event
Primary	Multiple sclerosis impact on employment		At one single visit, 15 years after the subject's first clinical event
Primary	Resource use assessment questions: Help from family/regular ambulatory services		At one single visit, 15 years after the subject's first clinical event
Primary	Resource use assessment questions: Additional ambulatory services during relapse		At one single visit, 15 years after the subject's first clinical event
Primary	Resource use assessment questions: Adaptions (past 6 months)		At one single visit, 15 years after the subject's first clinical event
Secondary	Symbol Digit Modalities Test score (SDMT score)	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
Secondary	Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)		At one single visit, 15 years after the subject's first clinical event
Secondary	Relation of mental processing speed and MRI parameters		At one single visit, 15 years after the subject's first clinical event
Secondary	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	Over 15 years since the subject´s first clinical event
Secondary	European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score		Over 15 years since the subject`s first clinical event
Secondary	Functional Assessment of Multiple Sclerosis (FAMS score)	FAMS: Functional Assessment of Multiple Sclerosis; Questionnaire measuring health-related quality of life	Over 15 years since the subject´s first clinical event
Secondary	Fatigue Scale for Motor and Cognitive Functions (FSMC score)		At one single visit, 15 years after the subject's first clinical event
Secondary	Center of Epidemiological Studies for Depression (CES-D) score		At one single visit, 15 years after the subject's first clinical event
Secondary	Time to second line therapy		Over 15 years since the subject´s first clinical event
Secondary	Time to first disease-modifying therapies (DMT) other than IFNB-1b		Over 15 years since the subject´s first clinical event

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