Multiple SclerosisPhase 4NCT03269175
BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
A Phase 4 study testing Brain MRI and Blood sampling in people with Multiple Sclerosis, run by Bayer at 61 sites in 18 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Brain MRI and Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 61 sitesin 18 countries
- Study dates
- 29 Sep 2017to 24 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
Who cannot join
- 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)
Trial locations and contacts
61 sites in 18 countries.
61 sites in 18 countries
Germany10 sites
Universitätsklinikum Charite zu Berlin
Berlin, 10117
Heinrich-Heine-Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
HELIOS Klinikum Erfurt GmbH
Erfurt, Thuringia, 99089
Universitätsmedizin der Georg-August-Universität Göttingen
Göttingen, Lower Saxony, 37075
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Saxony-Anhalt, 06120
Krankenhaus Hennigsdorf
Hennigsdorf, Brandenburg, 16761
Universitätsklinik Gießen und Marburg GmbH
Marburg, Hesse, 35043
Klinikum der Universität München Grosshadern
München, Bavaria, 81377
Sana Klinikum Offenbach GmbH
Offenbach, Hesse, 63069
Bezirksklinikum
Regensburg, Bavaria, 93053
Spain6 sites
Ciutat Sanitària i Universitaria de la Vall d'Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Ciutat Sanitària i Universitària de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Regional de Málaga
Málaga, 29010
Hospital Universitario Virgen de la Macarena
Seville, Andalusia, 41071
Hospital Universitari i Politècnic La Fe
Valencia, 46026
France5 sites
Hôpital Pellegrin - Bordeaux
Bordeaux, 33000
Hopital general
Dijon, 21033
Hopital Roger Salengro
Lille, 59037
Hôpital Pasteur - Nice
Nice, 06200
Hôpital Pontchaillou
Rennes, 35033
Italy5 sites
Ospedale San Raffaele
Milan, Lombardy, 20132
IRCCS Ist Neurologico Nazionale C.Mondino
Pavia, Lombardy, 27100
A.O.U. Città della Salute e della Scienza di Torino
Torino, Tuscany, 10126
A.O.U. San Luigi Gonzaga
Turin, Piedmont, 10043
ASST Valle Olona
Varese, Lombardy, 21013
Poland5 sites
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Bydgoszcz, 85-681
Szpital Uniwersytecki w Krakowie
Krakow, 30-503
Szpital im. N. Barlickiego
Lodz, 90-153
Samodzielny Publiczny Szpital Kliniczny nr 4
Lublin, 20-090
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, 50-556
Belgium4 sites
CU Saint-Luc/UZ St-Luc
Bruxelles - Brussel, 1200
UZ Gent
Ghent, 9000
UZ Leuven Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, 4000
Czechia4 sites
Fakultni nemocnice Brno
Brno, 625 00
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
Fakultni nemocnice Ostrava
Ostrava-Poruba, 708 52
Vseobecna fakultni nemocnice v Praze
Prague, 121 11
Hungary4 sites
Peterfy Sandor utcai Korhaz - Rendelointezet
Budapest, 1076
Uzsoki Utcai Korhaz
Budapest, 1145
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4012
Szent-Gyorgyi Albert Orvostudomanyi Egyetem
Szeged, 6720
United Kingdom4 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
Ninewells Hospital
Dundee, DD1 9SY
Charing Cross Hospital
London
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
Canada3 sites
CHUM - Hopital Hotel-Dieu
Montreal, Quebec, H2X 0A9
Montreal Neurological Hospital
Montreal, Quebec, H3A 2B4
Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6
Austria2 sites
Medizinische Universität Graz
Graz, Styria, 8036
Landeskrankenhaus - Universitätskliniken Innsbruck
Innsbruck, 6020
Finland2 sites
Tampereen yliopistollinen sairaala, keskussairaala
Tampere, 33521
Terveystalo Turku
Turku, 20100
Switzerland2 sites
Universitätsspital Basel
Basel, Canton of Basel-City, 4031
Inselspital Universitätsspital Bern
Bern, 3010
Portugal1 site
Instituto Português de Oncologia Francisco Gentil - Coimbra
Coimbra, 3000-075
About this study
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Brain MRI, Blood sampling
- Keywords
- Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
Brain MRI will be performed
Blood samplingOther
Blood samples will be taken
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm 15 years ago | Other | This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) Receives: Other: Brain MRI; Other: Blood sampling |
| Placebo arm, offered treatment at MS diagnosis or at Month 24 | Other | This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) Receives: Other: Brain MRI; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria
Measured: Over 15 years since the subject´s first clinical event
Disease course since start of BENEFIT as assessed at the time of BENEFIT 15
Measured: Over 15 years since the subject's first clinical event
Time to first relapse
Measured: Over 15 years since the subject´s first clinical event
Time to recurrent relapse
Measured: Over 15 years since the subject´s first clinical event
Annualized relapse rate
Measured: Over 15 years since the subject´s first clinical event
Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)
Measured: Over 15 years since the subject´s first clinical event
Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)
Measured: 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
Measured: 15 years after the subject´s first clinical event
Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)
Measured: Over 15 years since the subject´s first clinical event
Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)
Measured: Over 15 years since the subject´s first clinical event
Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)
MSFC: Multiple Sclerosis Functional Composite
Measured: Over 15 years since the subject´s first clinical event
Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)
Measured: Over 15 years since the subject´s first clinical event
Time to use of ambulatory device
Measured: Over 15 years since the subject´s first clinical event
Time to dependence on ambulatory device
Measured: Over 15 years since the subject´s first clinical event
Time to use of wheelchair
Measured: Over 15 years since the subject´s first clinical event
Employment status (Standardized questions)
The current employment will be recorded
Measured: At one single visit, 15 years after the subject's first clinical event
Multiple sclerosis impact on employment
Measured: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Help from family/regular ambulatory services
Measured: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Additional ambulatory services during relapse
Measured: At one single visit, 15 years after the subject's first clinical event
Resource use assessment questions: Adaptions (past 6 months)
Measured: At one single visit, 15 years after the subject's first clinical event
Secondary outcomes (10)
Symbol Digit Modalities Test score (SDMT score)
SDMT: Symbol Digit Modalities Test, Cognitive test
For sustained attention, concentration and information processing speed
Measured: 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)
Measured: At one single visit, 15 years after the subject's first clinical event
Relation of mental processing speed and MRI parameters
Measured: 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
Measured: Over 15 years since the subject´s first clinical event
European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score
Measured: 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
Measured: Over 15 years since the subject´s first clinical event
Fatigue Scale for Motor and Cognitive Functions (FSMC score)
Measured: At one single visit, 15 years after the subject's first clinical event
Center of Epidemiological Studies for Depression (CES-D) score
Measured: At one single visit, 15 years after the subject's first clinical event
Time to second line therapy
Measured: Over 15 years since the subject´s first clinical event
Time to first disease-modifying therapies (DMT) other than IFNB-1b
Measured: Over 15 years since the subject´s first clinical event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start29 Sep 2017
- Primary completion24 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269175
- Sponsor's protocol ID
- 19215
- Other IDs
- 2017-001176-31, 2017
- Status last verified
- May 2019
- First submitted
- 9 Aug 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies
- ClinicalTrials.gov ID
- NCT03269175
- Acronym / sponsor ID
- 19215
- Conditions
- Multiple Sclerosis
- Keywords
- Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm 15 years ago | Other | Other: Brain MRI, Other: Blood samplingThis long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) |
| Placebo arm, offered treatment at MS diagnosis or at Month 24 | Other | Other: Brain MRI, Other: Blood samplingThis long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIBrain MRI will be performed | Other | Experimental arm 15 years ago, Placebo arm, offered treatment at MS diagnosis or at Month 24 |
| Blood samplingBlood samples will be taken | Other | Experimental arm 15 years ago, Placebo arm, offered treatment at MS diagnosis or at Month 24 |
Primary outcome
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)
Time frame: 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)
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)
Time frame: At one single visit, 15 years after the subject's first clinical event
The current employment will be recorded
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
10 secondary outcomes
Symbol Digit Modalities Test score (SDMT score)
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
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brain MRI and Blood sampling in people with Multiple Sclerosis, run by Bayer at 61 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Germany, Spain, France, Italy, Poland and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.