Clinical trial NCT03269175: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-08-31
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
timeFrame: Over 15 years since the subject´s first clinical event
measure: Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
timeFrame: Over 15 years since the subject's first clinical event
measure: Time to first relapse
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to recurrent relapse
timeFrame: Over 15 years since the subject´s first clinical event
measure: Annualized relapse rate
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination
timeFrame: 15 years after the subject´s first clinical event
measure: Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to use of ambulatory device
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to dependence on ambulatory device
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to use of wheelchair
timeFrame: Over 15 years since the subject´s first clinical event
measure: Employment status (Standardized questions)
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Multiple sclerosis impact on employment
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Help from family/regular ambulatory services
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Additional ambulatory services during relapse
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Resource use assessment questions: Adaptions (past 6 months)
timeFrame: At one single visit, 15 years after the subject's first clinical event
Secondary outcomes:
measure: Symbol Digit Modalities Test score (SDMT score)
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Relation of mental processing speed and MRI parameters
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score
timeFrame: Over 15 years since the subject´s first clinical event
measure: European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
timeFrame: Over 15 years since the subject's first clinical event
measure: Functional Assessment of Multiple Sclerosis (FAMS score)
timeFrame: Over 15 years since the subject´s first clinical event
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC score)
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Center of Epidemiological Studies for Depression (CES-D) score
timeFrame: At one single visit, 15 years after the subject's first clinical event
measure: Time to second line therapy
timeFrame: Over 15 years since the subject´s first clinical event
measure: Time to first disease-modifying therapies (DMT) other than IFNB-1b
timeFrame: Over 15 years since the subject´s first clinical event
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Landeskrankenhaus - Universitätskliniken Innsbruck
city: Bruxelles - Brussel
country: Belgium
facility: CU Saint-Luc/UZ St-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liege
country: Belgium
facility: CHU de Liège
city: Ottawa
country: Canada
facility: Ottawa Hospital-General Campus
state: Ontario
city: Montreal
country: Canada
facility: CHUM - Hopital Hotel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Hospital
state: Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Glostrup
country: Denmark
facility: Amtssygehuset Glostrup
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala, keskussairaala
city: Turku
country: Finland
facility: Terveystalo Turku
city: Bordeaux
country: France
facility: Hôpital Pellegrin - Bordeaux
city: Dijon
country: France
facility: Hopital general
city: Lille
country: France
facility: Hopital Roger Salengro
city: Nice
country: France
facility: Hôpital Pasteur - Nice
city: Rennes Cedex
country: France
facility: Hôpital Pontchaillou
city: München
country: Germany
facility: Klinikum der Universität München Grosshadern
state: Bayern
city: Regensburg
country: Germany
facility: Bezirksklinikum
state: Bayern
city: Hennigsdorf
country: Germany
facility: Krankenhaus Hennigsdorf
state: Brandenburg
city: Marburg
country: Germany
facility: Universitätsklinik Gießen und Marburg GmbH
state: Hessen
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach GmbH
state: Hessen
city: Goettingen
country: Germany
facility: Universitätsmedizin der Georg-August-Universität Göttingen
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-Universität Düsseldorf
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
state: Sachsen-Anhalt
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH
state: Thüringen
city: Berlin
country: Germany
facility: Universitätsklinikum Charite zu Berlin
city: Budapest
country: Hungary
facility: Peterfy Sandor utcai Korhaz - Rendelointezet
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szent-Gyorgyi Albert Orvostudomanyi Egyetem
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Hospital Ein Kerem
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombardia
city: Pavia
country: Italy
facility: IRCCS Ist Neurologico Nazionale C.Mondino
state: Lombardia
city: Varese
country: Italy
facility: ASST Valle Olona
state: Lombardia
city: Torino
country: Italy
facility: A.O.U. San Luigi Gonzaga
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino
state: Toscana
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland universitetssjukehus
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Lodz
country: Poland
facility: Szpital im. N. Barlickiego
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia Francisco Gentil - Coimbra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
state: Andalucía
city: L'Hospitalet de Llobregat
country: Spain
facility: Ciutat Sanitària i Universitària de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Malaga
country: Spain
facility: Hospital Regional de Málaga
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel-Stadt
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
References: