BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT03269175
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Resource use assessment questions: Adaptions (past 6 months) At one single visit, 15 years after the subject's first clinical event 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 Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression) 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 Employment status (Standardized questions) At one single visit, 15 years after the subject's first clinical event The current employment will be recorded
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 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) Over 15 years since the subject´s first clinical event MSFC: Multiple Sclerosis Functional Composite
Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function) 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 Resource use assessment questions: Additional ambulatory services during relapse 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
- Secondary Outcome Measures
Name Time Method European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score Over 15 years since the subject´s first clinical event EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
Symbol Digit Modalities Test score (SDMT score) At one single visit, 15 years after the subject's first clinical event SDMT: Symbol Digit Modalities Test, Cognitive test
For sustained attention, concentration and information processing speedEuropean Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score Over 15 years since the subject's first clinical event 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 Relation of mental processing speed and MRI parameters 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 first disease-modifying therapies (DMT) other than IFNB-1b Over 15 years since the subject´s first clinical event Functional Assessment of Multiple Sclerosis (FAMS score) Over 15 years since the subject´s first clinical event FAMS: Functional Assessment of Multiple Sclerosis
Questionnaire measuring health-related quality of lifeFatigue Scale for Motor and Cognitive Functions (FSMC 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
Trial Locations
- Locations (61)
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Landeskrankenhaus - Universitätskliniken Innsbruck
🇦🇹Innsbruck, Austria
CU Saint-Luc/UZ St-Luc
🇧🇪Bruxelles - Brussel, Belgium
UZ Gent
🇧🇪Gent, Belgium
UZ Leuven Gasthuisberg
🇧🇪Leuven, Belgium
CHU de Liège
🇧🇪Liege, Belgium
Ottawa Hospital-General Campus
🇨🇦Ottawa, Ontario, Canada
CHUM - Hopital Hotel-Dieu
🇨🇦Montreal, Quebec, Canada
Montreal Neurological Hospital
🇨🇦Montreal, Quebec, Canada
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Scroll for more (51 remaining)Medizinische Universität Graz🇦🇹Graz, Steiermark, Austria