Trial Condition(s):
Multiple Sclerosis
BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
Bayer Identifier:
19215
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Heinrich-Heine-Universität Düsseldorf Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Charing Cross Hospital London, United Kingdom | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Pellegrin - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hopital general Dijon, France, 21033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hopital Roger Salengro LILLE, France, 59037 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 30-503 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szpital im. N. Barlickiego Lodz, Poland, 90-153 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego Wroclaw, Poland, 50-556 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Bydgoszcz, Poland, 85-681 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations ASST Valle Olona Varese, Italy, 21013 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Regional de Málaga Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni Nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Fakultni nemocnice Ostrava Ostrava-Poruba, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 121 11 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Landeskrankenhaus - Universitätskliniken Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Peterfy Sandor utcai Korhaz - Rendelointezet Budapest, Hungary, 1076 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Uzsoki Utcai Korhaz Budapest, Hungary, 1145 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Terveystalo Turku Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHUM - Hopital Hotel-Dieu Montreal, Canada, H2X 0A9 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Montreal Neurological Hospital Montreal, Canada, H3A 2B4 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Szent-Gyorgyi Albert Orvostudomanyi Egyetem Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Krankenhaus Hennigsdorf Hennigsdorf, Germany, 16761 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Klinikum der Universität München Grosshadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sana Klinikum Offenbach GmbH Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Bezirksklinikum Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations CHU de Liège LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations UZ Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Pontchaillou RENNES CEDEX, France, 35033 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hôpital Pasteur - Nice NICE, France, 06200 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ninewells Hospital Dundee, United Kingdom, DD1 9SY | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Royal Hallamshire Hospital Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. San Luigi Gonzaga Torino, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitario Virgen de la Macarena Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Instituto Português de Oncologia Francisco Gentil - Coimbra Coimbra, Portugal, 3000-075 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Ospedale San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IRCCS Ist Neurologico Nazionale C.Mondino Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Goettingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Helse Bergen HF Haukeland universitetssjukehus Bergen, Norway, 5021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations A.O.U. Città della Salute e della Scienza di Torino Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Amtssygehuset Glostrup Glostrup, Denmark, DK-2600 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
Trial Type:
Interventional
Intervention Type:
Other
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteriaTimeframe: Over 15 years since the subject´s first clinical event
- Disease course since start of BENEFIT as assessed at the time of BENEFIT 15Timeframe: Over 15 years since the subject`s first clinical event
- Time to first relapseTimeframe: Over 15 years since the subject´s first clinical event
- Time to recurrent relapseTimeframe: Over 15 years since the subject´s first clinical event
- Annualized relapse rateTimeframe: Over 15 years since the subject´s first clinical event
- Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)Timeframe: Over 15 years since the subject´s first clinical event
- Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)Timeframe: 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 examinationTimeframe: 15 years after the subject´s first clinical event
- Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)Timeframe: Over 15 years since the subject´s first clinical event
- Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)Timeframe: Over 15 years since the subject´s first clinical event
- Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)MSFC: Multiple Sclerosis Functional CompositeTimeframe: Over 15 years since the subject´s first clinical event
- Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)Timeframe: Over 15 years since the subject´s first clinical event
- Time to use of ambulatory deviceTimeframe: Over 15 years since the subject´s first clinical event
- Time to dependence on ambulatory deviceTimeframe: Over 15 years since the subject´s first clinical event
- Time to use of wheelchairTimeframe: Over 15 years since the subject´s first clinical event
- Employment status (Standardized questions)The current employment will be recordedTimeframe: At one single visit, 15 years after the subject’s first clinical event
- Multiple sclerosis impact on employmentTimeframe: At one single visit, 15 years after the subject’s first clinical event
- Resource use assessment questions: Help from family/regular ambulatory servicesTimeframe: At one single visit, 15 years after the subject’s first clinical event
- Resource use assessment questions: Additional ambulatory services during relapseTimeframe: At one single visit, 15 years after the subject’s first clinical event
- Resource use assessment questions: Adaptions (past 6 months)Timeframe: At one single visit, 15 years after the subject’s first clinical event
Secondary Outcome
- Symbol Digit Modalities Test score (SDMT score)SDMT: Symbol Digit Modalities Test, Cognitive test For sustained attention, concentration and information processing speedTimeframe: 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)Timeframe: At one single visit, 15 years after the subject’s first clinical event
- Relation of mental processing speed and MRI parametersTimeframe: 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) scoreEQ-5D: European Quality of Life – 5 dimensions Questionnaire measuring health-related quality of lifeTimeframe: Over 15 years since the subject´s first clinical event
- European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) scoreTimeframe: 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 lifeTimeframe: Over 15 years since the subject´s first clinical event
- Fatigue Scale for Motor and Cognitive Functions (FSMC score)Timeframe: At one single visit, 15 years after the subject’s first clinical event
- Center of Epidemiological Studies for Depression (CES-D) scoreTimeframe: At one single visit, 15 years after the subject’s first clinical event
- Time to second line therapyTimeframe: Over 15 years since the subject´s first clinical event
- Time to first disease-modifying therapies (DMT) other than IFNB-1bTimeframe: Over 15 years since the subject´s first clinical event
Additional Information
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