BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Brain MRI
- Blood sampling
What it measured
Main measures
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
RelapsesTime to recurrent relapse
Over 15 years since the subject´s first clinical event
RelapsesAnnualized relapse rate
Over 15 years since the subject´s first clinical event
RelapsesTime 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
Disability progressionNumber of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
Over 15 years since the subject´s first clinical event
Disability progressionNumber of subjects with confirmed 2.5-point EDSS progression (Disability progression)
Over 15 years since the subject´s first clinical event
Disability progressionMultiple Sclerosis Functional Composite (MSFC) score (Neurological status)
Over 15 years since the subject´s first clinical event
Disability progressionPaced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
Over 15 years since the subject´s first clinical event
Thinking and memoryTime 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)
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
RelapsesResource use assessment questions: Adaptions (past 6 months)
At one single visit, 15 years after the subject's first clinical event
As this is a long-term follow-up, the study is purely exploratory and descriptive in nature. Accordingly, a primary variable has not been selected.
Other measures (11)
Symbol Digit Modalities Test score (SDMT score)
At one single visit, 15 years after the subject's first clinical event
Thinking and memoryRelation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)
At one single visit, 15 years after the subject's first clinical event
Thinking and memoryFatigueRelation of mental processing speed and MRI parameters
At one single visit, 15 years after the subject's first clinical event
MRI lesionsThinking and memoryEuropean Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score
Over 15 years since the subject´s first clinical event
Quality of life (reported by participants)European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
Over 15 years since the subject's first clinical event
Quality of life (reported by participants)Functional Assessment of Multiple Sclerosis (FAMS score)
Over 15 years since the subject´s first clinical event
Quality of life (reported by participants)Fatigue Scale for Motor and Cognitive Functions (FSMC score)
At one single visit, 15 years after the subject's first clinical event
Thinking and memoryFatigueCenter of Epidemiological Studies for Depression (CES-D) score
At one single visit, 15 years after the subject's first clinical event
Mood and sleepTime 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
Who could take part
Early (CIS/RIS) · 18 and over
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Sept 2017
Main results due
May 2018
Finished
May 2018