BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 261
- Locations
- 120
- Primary Endpoint
- Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Experimental arm 15 years ago
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Intervention: Brain MRI (Other)
Experimental arm 15 years ago
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Intervention: Blood sampling (Other)
Placebo arm, offered treatment at MS diagnosis or at Month 24
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Intervention: Brain MRI (Other)
Placebo arm, offered treatment at MS diagnosis or at Month 24
This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Intervention: Blood sampling (Other)
Outcomes
Primary Outcomes
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
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
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
Employment status (Standardized questions)
Time Frame: 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)
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 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)
Time Frame: Over 15 years since the subject´s first clinical event
MSFC: Multiple Sclerosis Functional Composite
Resource use assessment questions: Adaptions (past 6 months)
Time Frame: At one single visit, 15 years after 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 wheelchair
Time Frame: Over 15 years since 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
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
Secondary Outcomes
- 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)
- Symbol Digit Modalities Test score (SDMT score)(At one single visit, 15 years after the subject's first clinical event)
- European 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)
- Fatigue 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)