A Phase 4 interventional study of Brain MRI and Blood sampling in Multiple Sclerosis, sponsored by Bayer. Completed at 61 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Other: Brain MRI · Other: Blood sampling
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Other: Brain MRI · Other: Blood sampling
Brain MRI will be performed
Blood samples will be taken
Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
Time frame: Over 15 years since the subject´s first clinical event
Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
Time frame: Over 15 years since the subject's first clinical event
Time to first relapse
Time frame: Over 15 years since the subject´s first clinical event
Time to recurrent relapse
Time frame: Over 15 years since the subject´s first clinical event
Annualized relapse rate
Time frame: Over 15 years since the subject´s first clinical event
Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
Time frame: Over 15 years since the subject´s first clinical event
Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
Time frame: 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
Time frame: 15 years after the subject´s first clinical event
Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
Time frame: Over 15 years since the subject´s first clinical event
Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
Time frame: Over 15 years since the subject´s first clinical event
Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
MSFC: Multiple Sclerosis Functional Composite
Time frame: Over 15 years since the subject´s first clinical event
Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
Time frame: Over 15 years since the subject´s first clinical event
Time to use of ambulatory device
Time frame: Over 15 years since the subject´s first clinical event
Time to dependence on ambulatory device
Time frame: Over 15 years since the subject´s first clinical event
Time to use of wheelchair
Time frame: Over 15 years since the subject´s first clinical event
Employment status (Standardized questions)
The current employment will be recorded
Time frame: At one single visit, 15 years after the subject's first clinical event
Multiple sclerosis impact on employment
Time frame: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Help from family/regular ambulatory services
Time frame: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Additional ambulatory services during relapse
Time frame: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Adaptions (past 6 months)
Time frame: At one single visit, 15 years after the subject's first clinical event
Symbol Digit Modalities Test score (SDMT score)
SDMT: Symbol Digit Modalities Test, Cognitive test For sustained attention, concentration and information processing speed
Time frame: 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)
Time frame: At one single visit, 15 years after the subject's first clinical event
Relation of mental processing speed and MRI parameters
Time frame: 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
Time frame: Over 15 years since the subject´s first clinical event
European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
Time frame: 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
Time frame: Over 15 years since the subject´s first clinical event
Fatigue Scale for Motor and Cognitive Functions (FSMC score)
Time frame: At one single visit, 15 years after the subject's first clinical event
Center of Epidemiological Studies for Depression (CES-D) score
Time frame: At one single visit, 15 years after the subject's first clinical event
Time to second line therapy
Time frame: Over 15 years since the subject´s first clinical event
Time to first disease-modifying therapies (DMT) other than IFNB-1b
Time frame: Over 15 years since the subject´s first clinical event
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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