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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03269175
Other study ID # 19215
Secondary ID 2017-001176-31
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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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