Multiple Sclerosis
Conditions
Keywords
Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis
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.
Interventions
OTHERBrain MRI
Brain MRI will be performed
OTHERBlood sampling
Blood samples will be taken
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| 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 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 | — |
| Resource use assessment questions: Adaptions (past 6 months) | 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 | — |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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) | Over 15 years since the subject´s first clinical event | FAMS: Functional Assessment of Multiple Sclerosis Questionnaire measuring health-related quality of life |
| 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 | — |
| 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 speed |
Countries
Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed