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

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Brain MRI; Other: Blood sampling

• Registration Number: NCT03269175
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-30
• Study First Posted: 2017-08-31
• Study Start: 2017-09-29
• Primary Completion: 2018-05-24
• Study Completion: 2018-05-24
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

• All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm 15 years ago	Blood sampling	This 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	Blood sampling	This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)
Experimental arm 15 years ago	Brain MRI	This 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	Brain MRI	This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Primary Outcome Measures

Name	Time	Method
Resource use assessment questions: Adaptions (past 6 months)	At one single visit, 15 years after the subject's first clinical event
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
Time to recurrent relapse	Over 15 years since the subject´s first clinical event
Annualized relapse rate	Over 15 years since the subject´s first clinical event
Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)	Over 15 years since the subject´s first clinical event
Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)	Over 15 years since the subject´s first clinical event
Time 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
Employment status (Standardized questions)	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)	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
Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)	Over 15 years since the subject´s first clinical event
Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)	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)	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
Resource use assessment questions: Additional ambulatory services during relapse	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

Secondary Outcome Measures

Name	Time	Method
Time to first disease-modifying therapies (DMT) other than IFNB-1b	Over 15 years since the subject´s first clinical event
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	EQ-5D: European Quality of Life - 5 dimensions Questionnaire measuring health-related quality of life
Symbol Digit Modalities Test score (SDMT score)	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
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
Functional Assessment of Multiple Sclerosis (FAMS score)	Over 15 years since the subject´s first clinical event	FAMS: Functional Assessment of Multiple Sclerosis; Questionnaire measuring health-related quality of life
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

Trial Locations

Locations (61)

Terveystalo Turku; 🇫🇮 Turku, Finland

UZ Gent; 🇧🇪 Gent, Belgium

Instituto Português de Oncologia Francisco Gentil - Coimbra; 🇵🇹 Coimbra, Portugal

Landeskrankenhaus - Universitätskliniken Innsbruck; 🇦🇹 Innsbruck, Austria

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH; 🇩🇪 Halle, Sachsen-Anhalt, Germany

HELIOS Klinikum Erfurt GmbH; 🇩🇪 Erfurt, Thüringen, Germany

Szpital im. N. Barlickiego; 🇵🇱 Lodz, Poland

Ottawa Hospital-General Campus; 🇨🇦 Ottawa, Ontario, Canada

A.O.U. San Luigi Gonzaga; 🇮🇹 Torino, Piemonte, Italy

Helse Bergen HF Haukeland universitetssjukehus; 🇳🇴 Bergen, Norway

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ; 🇵🇱 Bydgoszcz, Poland

ASST Valle Olona; 🇮🇹 Varese, Lombardia, Italy

Szpital Uniwersytecki w Krakowie; 🇵🇱 Krakow, Poland

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego; 🇵🇱 Wroclaw, Poland

CHUM - Hopital Hotel-Dieu; 🇨🇦 Montreal, Quebec, Canada

Montreal Neurological Hospital; 🇨🇦 Montreal, Quebec, Canada

Vseobecna fakultni nemocnice v Praze; 🇨🇿 Praha 2, Czechia

Amtssygehuset Glostrup; 🇩🇰 Glostrup, Denmark

Tampereen yliopistollinen sairaala, keskussairaala; 🇫🇮 Tampere, Finland

Hopital Roger Salengro; 🇫🇷 Lille, France

Hôpital Pasteur - Nice; 🇫🇷 Nice, France

Heinrich-Heine-Universität Düsseldorf; 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany

Medizinische Universität Graz; 🇦🇹 Graz, Steiermark, Austria

CHU de Liège; 🇧🇪 Liege, Belgium

Hôpital Pellegrin - Bordeaux; 🇫🇷 Bordeaux, France

Hôpital Pontchaillou; 🇫🇷 Rennes Cedex, France

Samodzielny Publiczny Szpital Kliniczny nr 4; 🇵🇱 Lublin, Poland

Fakultni nemocnice Ostrava; 🇨🇿 Ostrava-Poruba, Czechia

CU Saint-Luc/UZ St-Luc; 🇧🇪 Bruxelles - Brussel, Belgium

UZ Leuven Gasthuisberg; 🇧🇪 Leuven, Belgium

Fakultni nemocnice Brno; 🇨🇿 Brno, Czechia

Fakultni Nemocnice Hradec Kralove; 🇨🇿 Hradec Kralove, Czechia

Hopital general; 🇫🇷 Dijon, France

Universitätsmedizin der Georg-August-Universität Göttingen; 🇩🇪 Goettingen, Niedersachsen, Germany

Debreceni Egyetem Klinikai Kozpont; 🇭🇺 Debrecen, Hungary

IRCCS Ist Neurologico Nazionale C.Mondino; 🇮🇹 Pavia, Lombardia, Italy

Universitätsklinikum Charite zu Berlin; 🇩🇪 Berlin, Germany

Peterfy Sandor utcai Korhaz - Rendelointezet; 🇭🇺 Budapest, Hungary

Klinikum der Universität München Grosshadern; 🇩🇪 München, Bayern, Germany

Bezirksklinikum; 🇩🇪 Regensburg, Bayern, Germany

Universitätsspital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland

Universitätsklinik Gießen und Marburg GmbH; 🇩🇪 Marburg, Hessen, Germany

Sana Klinikum Offenbach GmbH; 🇩🇪 Offenbach, Hessen, Germany

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

Krankenhaus Hennigsdorf; 🇩🇪 Hennigsdorf, Brandenburg, Germany

Szent-Gyorgyi Albert Orvostudomanyi Egyetem; 🇭🇺 Szeged, Hungary

Ospedale San Raffaele; 🇮🇹 Milano, Lombardia, Italy

A.O.U. Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Toscana, Italy

Inselspital Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Royal Hallamshire Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Andalucía, Spain

Ciutat Sanitària i Universitària de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Sahlgrenska Universitetssjukhuset; 🇸🇪 Göteborg, Sweden

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, United Kingdom

Uzsoki Utcai Korhaz; 🇭🇺 Budapest, Hungary

Hadassah Hebrew University Hospital Ein Kerem; 🇮🇱 Jerusalem, Israel

Hospital Clínic i Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Ciutat Sanitària i Universitaria de la Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Regional de Málaga; 🇪🇸 Malaga, Spain

Charing Cross Hospital; 🇬🇧 London, United Kingdom