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
Among 37 studies in Multiple Sclerosis by Bayer — none open to participants now, 1 under way, none of them phase 3. Multiple Sclerosis · Bayer.
Among the 37 studies in Multiple Sclerosis by Bayer, this one is one of 2 that started in 2017, is one of 3 in phase 4, and was the 32nd registered.
3,267 studies on the registry are indexed under Multiple Sclerosis; 662 are open to participants now.
Browse Multiple Sclerosis studies →None of the 37 studies in Multiple Sclerosis by Bayer is open now. The open studies under Multiple Sclerosis, anywhere →
Of the 430 Multiple Sclerosis studies recruiting now, 163 (38%) set no upper age limit and 211 (49%) stop at 75 or younger; 40 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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37 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 261 is above the median of 50 across 2,203 interventional studies indexed under Multiple Sclerosis.
Median enrollment 71 across the 9 interventional studies, 145 across the 28 observational. Of the 34 that completed or were terminated, 3 (9%) have results posted.
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Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 37 studies in Multiple Sclerosis by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Ran from Sep 2017 to primary completion in May 2018, 7 months.
Of 36 industry-sponsored phase 4 interventional studies under Multiple Sclerosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 37. This study's 7 months is below that.
Counting every sponsor, half of 69 studies reached it within 34 months; a quarter within 23 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
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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