BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

May 14, 2019 updated by: Bayer

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
261

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Landeskrankenhaus - Universitätskliniken Innsbruck
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universitat Graz
  • Belgium
      • Bruxelles - Brussel, Belgium, 1200
        • CU Saint-Luc/UZ St-Luc
      • Gent, Belgium, 9000
        • UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Liege, Belgium, 4000
        • CHU de Liège
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital-General Campus
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Hospital
      • Montreal, Quebec, Canada, H2X 0A9
        • CHUM - Hopital Hotel-Dieu
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
      • Praha 2, Czechia, 121 11
        • Vseobecna fakultni nemocnice v Praze
  • Denmark
      • Glostrup, Denmark, DK-2600
        • Amtssygehuset Glostrup
  • Finland
      • Tampere, Finland, 33521
        • Tampereen yliopistollinen sairaala, keskussairaala
      • Turku, Finland, 20100
        • Terveystalo Turku
  • France
      • Bordeaux, France, 33000
        • Hôpital Pellegrin - Bordeaux
      • Dijon, France, 21033
        • Hôpital Général
      • Lille, France, 59037
        • Hôpital Roger Salengro
      • Nice, France, 06200
        • Hôpital Pasteur - Nice
      • Rennes Cedex, France, 35033
        • Hopital Pontchaillou
  • Germany
      • Berlin, Germany, 10117
        • Universitätsklinikum Charite zu Berlin
    • Bayern
      • München, Bayern, Germany, 81377
        • Klinikum der Universität München Großhadern
      • Regensburg, Bayern, Germany, 93053
        • Bezirksklinikum
    • Brandenburg
      • Hennigsdorf, Brandenburg, Germany, 16761
        • Krankenhaus Hennigsdorf
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinik Gießen und Marburg GmbH
      • Offenbach, Hessen, Germany, 63069
        • Sana Klinikum Offenbach GmbH
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, 37075
        • Universitätsmedizin der Georg-August-Universität Göttingen
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Heinrich-Heine-Universität Düsseldorf
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH
    • Thüringen
      • Erfurt, Thüringen, Germany, 99089
        • Helios Klinikum Erfurt GmbH
  • Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1076
        • Peterfy Sandor utcai Korhaz - Rendelointezet
      • Debrecen, Hungary, 4012
        • Debreceni Egyetem Klinikai Kozpont
      • Szeged, Hungary, 6720
        • Szent-Gyorgyi Albert Orvostudomanyi Egyetem
  • Israel
      • Jerusalem, Israel
        • Hadassah Hebrew University Hospital Ein Kerem
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Ospedale San Raffaele
      • Pavia, Lombardia, Italy, 27100
        • IRCCS Ist Neurologico Nazionale C.Mondino
      • Varese, Lombardia, Italy, 21013
        • ASST Valle Olona
    • Piemonte
      • Torino, Piemonte, Italy, 10043
        • A.O.U. San Luigi Gonzaga
    • Toscana
      • Torino, Toscana, Italy, 10126
        • A.O.U. Città della Salute e Della Scienza di Torino
  • Norway
      • Bergen, Norway, 5021
        • Helse Bergen HF Haukeland Universitetssjukehus
  • Poland
      • Bydgoszcz, Poland, 85-681
        • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
      • Krakow, Poland, 30-503
        • Szpital Uniwersytecki w Krakowie
      • Lodz, Poland, 90-153
        • Szpital im. N. Barlickiego
      • Lublin, Poland, 20-090
        • Samodzielny Publiczny Szpital Kliniczny nr 4
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Instituto Português de Oncologia Francisco Gentil - Coimbra
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Ciutat Sanitaria i Universitaria de la Vall d'Hebron
      • Malaga, Spain, 29010
        • Hospital Regional de Malaga
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • Andalucía
      • Sevilla, Andalucía, Spain, 41071
        • Hospital Universitario Virgen de la Macarena
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Ciutat Sanitaria i Universitaria de Bellvitge
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
  • Switzerland
      • Bern, Switzerland, 3010
        • INSELSPITAL Universitätsspital Bern
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Universitatsspital Basel
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • London, United Kingdom
        • Charing Cross Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Other: Brain MRI
Brain MRI will be performed
Other: Blood sampling
Blood samples will be taken
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)
Other: Brain MRI
Brain MRI will be performed
Other: Blood sampling
Blood samples will be taken

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
At one single visit, 15 years after the subject's first clinical event

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symbol Digit Modalities Test score (SDMT score)
Time Frame: At one single visit, 15 years after the subject's first clinical event

SDMT: Symbol Digit Modalities Test, Cognitive test

For sustained attention, concentration and information processing speed
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
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
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
EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
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
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

FAMS: Functional Assessment of Multiple Sclerosis

Questionnaire measuring health-related quality of life
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
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
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
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
Over 15 years since the subject´s first clinical event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19215
  • 2017-001176-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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