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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001176-31 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm 15 years ago | Other | This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) |
|
| Placebo arm, offered treatment at MS diagnosis or at Month 24 | Other | This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain MRI | Other | Brain MRI will be performed |
|
| 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 | Over 15 years since the subject´s first clinical event | |
| Disease course since start of BENEFIT as assessed at the time of BENEFIT 15 | Over 15 years since the subject's first clinical event | |
| Time to first relapse | Over 15 years since the subject´s first clinical event | |
| Time to recurrent relapse | Over 15 years since the subject´s first clinical event | |
| Annualized relapse rate | Over 15 years since the subject´s first clinical event | |
| Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS) | Over 15 years since the subject´s first clinical event | |
| Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS) | 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 | 15 years after the subject´s first clinical event | |
| Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression) | Over 15 years since the subject´s first clinical event |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | Styria | 8036 | Austria | ||
| Landeskrankenhaus - Universitätskliniken Innsbruck |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| Blood sampling | Other | Blood samples will be taken |
|
| Number of subjects with confirmed 2.5-point EDSS progression (Disability progression) | Over 15 years since the subject´s first clinical event |
| Multiple Sclerosis Functional Composite (MSFC) score (Neurological status) | 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) | Over 15 years since the subject´s first clinical event |
| Time to use of ambulatory device | Over 15 years since the subject´s first clinical event |
| Time to dependence on ambulatory device | Over 15 years since the subject´s first clinical event |
| Time to use of wheelchair | Over 15 years since the subject´s first clinical event |
| Employment status (Standardized questions) | The current employment will be recorded | At one single visit, 15 years after the subject's first clinical event |
| Multiple sclerosis impact on employment | At one single visit, 15 years after the subject's first clinical event |
| Resource use assessment questions: Help from family/regular ambulatory services | At one single visit, 15 years after the subject's first clinical event |
| Resource use assessment questions: Additional ambulatory services during relapse | At one single visit, 15 years after the subject's first clinical event |
| Resource use assessment questions: Adaptions (past 6 months) | 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 | 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 | 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 | Over 15 years since the subject's first clinical event |
| 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 |
| Fatigue Scale for Motor and Cognitive Functions (FSMC score) | At one single visit, 15 years after the subject's first clinical event |
| Center of Epidemiological Studies for Depression (CES-D) score | At one single visit, 15 years after the subject's first clinical event |
| Time to second line therapy | Over 15 years since the subject´s first clinical event |
| Time to first disease-modifying therapies (DMT) other than IFNB-1b | Over 15 years since the subject´s first clinical event |
| Innsbruck |
| 6020 |
| Austria |
| CU Saint-Luc/UZ St-Luc | Bruxelles - Brussel | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Ottawa Hospital-General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| CHUM - Hopital Hotel-Dieu | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| Fakultni nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 121 11 | Czechia |
| Amtssygehuset Glostrup | Glostrup Municipality | DK-2600 | Denmark |
| Tampereen yliopistollinen sairaala, keskussairaala | Tampere | 33521 | Finland |
| Terveystalo Turku | Turku | 20100 | Finland |
| Hôpital Pellegrin - Bordeaux | Bordeaux | 33000 | France |
| Hopital general | Dijon | 21033 | France |
| Hopital Roger Salengro | Lille | 59037 | France |
| Hôpital Pasteur - Nice | Nice | 06200 | France |
| Hôpital Pontchaillou | Rennes | 35033 | France |
| Klinikum der Universität München Grosshadern | München | Bavaria | 81377 | Germany |
| Bezirksklinikum | Regensburg | Bavaria | 93053 | Germany |
| Krankenhaus Hennigsdorf | Hennigsdorf | Brandenburg | 16761 | Germany |
| Universitätsklinik Gießen und Marburg GmbH | Marburg | Hesse | 35043 | Germany |
| Sana Klinikum Offenbach GmbH | Offenbach | Hesse | 63069 | Germany |
| Universitätsmedizin der Georg-August-Universität Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| Heinrich-Heine-Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle | Saxony-Anhalt | 06120 | Germany |
| HELIOS Klinikum Erfurt GmbH | Erfurt | Thuringia | 99089 | Germany |
| Universitätsklinikum Charite zu Berlin | Berlin | 10117 | Germany |
| Peterfy Sandor utcai Korhaz - Rendelointezet | Budapest | 1076 | Hungary |
| Uzsoki Utcai Korhaz | Budapest | 1145 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4012 | Hungary |
| Szent-Gyorgyi Albert Orvostudomanyi Egyetem | Szeged | 6720 | Hungary |
| Hadassah Hebrew University Hospital Ein Kerem | Jerusalem | Israel |
| Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| IRCCS Ist Neurologico Nazionale C.Mondino | Pavia | Lombardy | 27100 | Italy |
| ASST Valle Olona | Varese | Lombardy | 21013 | Italy |
| A.O.U. San Luigi Gonzaga | Turin | Piedmont | 10043 | Italy |
| A.O.U. Città della Salute e della Scienza di Torino | Torino | Tuscany | 10126 | Italy |
| Helse Bergen HF Haukeland universitetssjukehus | Bergen | 5021 | Norway |
| 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Bydgoszcz | 85-681 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 30-503 | Poland |
| Szpital im. N. Barlickiego | Lodz | 90-153 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin | 20-090 | Poland |
| Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego | Wroclaw | 50-556 | Poland |
| Instituto Português de Oncologia Francisco Gentil - Coimbra | Coimbra | 3000-075 | Portugal |
| Hospital Universitario Virgen de la Macarena | Seville | Andalusia | 41071 | Spain |
| Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital Regional de Málaga | Málaga | 29010 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 413 45 | Sweden |
| Universitätsspital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| Inselspital Universitätsspital Bern | Bern | 3010 | Switzerland |
| Royal Hallamshire Hospital | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Charing Cross Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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