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

NCT03269175 | Completed Phase 4

• 2 other identifiers: 192152017-001176-31
• Study Type: interventional
• Target: 261
• Locations: 18 countries
• Sites: 61

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.

Conditions

Multiple Sclerosis

Keywords

Clinically Isolated Syndrome suggestive of Multiple Sclerosis or Multiple Sclerosis

Outcome Measures

Primary Outcomes (20)

• 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

• 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 and sustained 1-point EDSS progression (Disability progression)

  Over 15 years since 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)

  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)

  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

• Time to use of wheelchair

  Over 15 years since the subject´s first clinical event

• Employment status (Standardized questions)

  The current employment will be recorded

  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

• Resource use assessment questions: Additional ambulatory services during relapse

  At one single visit, 15 years after the subject's first clinical event

• Resource use assessment questions: Adaptions (past 6 months)

  At one single visit, 15 years after the subject's first clinical event

Secondary Outcomes (10)

• Symbol Digit Modalities Test score (SDMT score)

  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)

  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

• 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

• European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score

  Over 15 years since the subject's first clinical event

Study Arms (2)

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)

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)

Other: Brain MRI; Other: Blood sampling

Interventions

Brain MRI OTHER

Brain MRI will be performed

Experimental arm 15 years ago; Placebo arm, offered treatment at MS diagnosis or at Month 24

Blood sampling OTHER

Blood samples will be taken

Experimental arm 15 years ago; Placebo arm, offered treatment at MS diagnosis or at Month 24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (61)

Medizinische Universität Graz

Graz, Styria, 8036, Austria

Location

Landeskrankenhaus - Universitätskliniken Innsbruck

Innsbruck, 6020, Austria

Location

CU Saint-Luc/UZ St-Luc

Bruxelles - Brussel, 1200, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

CHUM - Hopital Hotel-Dieu

Montreal, Quebec, H2X 0A9, Canada

Location

Montreal Neurological Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Fakultni nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 121 11, Czechia

Location

Amtssygehuset Glostrup

Glostrup Municipality, DK-2600, Denmark

Location

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, 33521, Finland

Location

Terveystalo Turku

Turku, 20100, Finland

Location

Hôpital Pellegrin - Bordeaux

Bordeaux, 33000, France

Location

Hopital general

Dijon, 21033, France

Location

Hopital Roger Salengro

Lille, 59037, France

Location

Hôpital Pasteur - Nice

Nice, 06200, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Klinikum der Universität München Grosshadern

München, Bavaria, 81377, Germany

Location

Bezirksklinikum

Regensburg, Bavaria, 93053, Germany

Location

Krankenhaus Hennigsdorf

Hennigsdorf, Brandenburg, 16761, Germany

Location

Universitätsklinik Gießen und Marburg GmbH

Marburg, Hesse, 35043, Germany

Location

Sana Klinikum Offenbach GmbH

Offenbach, Hesse, 63069, Germany

Location

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, Saxony-Anhalt, 06120, Germany

Location

HELIOS Klinikum Erfurt GmbH

Erfurt, Thuringia, 99089, Germany

Location

Universitätsklinikum Charite zu Berlin

Berlin, 10117, Germany

Location

Peterfy Sandor utcai Korhaz - Rendelointezet

Budapest, 1076, Hungary

Location

Uzsoki Utcai Korhaz

Budapest, 1145, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4012, Hungary

Location

Szent-Gyorgyi Albert Orvostudomanyi Egyetem

Szeged, 6720, Hungary

Location

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel

Location

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

IRCCS Ist Neurologico Nazionale C.Mondino

Pavia, Lombardy, 27100, Italy

Location

ASST Valle Olona

Varese, Lombardy, 21013, Italy

Location

A.O.U. San Luigi Gonzaga

Turin, Piedmont, 10043, Italy

Location

A.O.U. Città della Salute e della Scienza di Torino

Torino, Tuscany, 10126, Italy

Location

Helse Bergen HF Haukeland universitetssjukehus

Bergen, 5021, Norway

Location

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, 85-681, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 30-503, Poland

Location

Szpital im. N. Barlickiego

Lodz, 90-153, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4

Lublin, 20-090, Poland

Location

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, 50-556, Poland

Location

Instituto Português de Oncologia Francisco Gentil - Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital Universitario Virgen de la Macarena

Seville, Andalusia, 41071, Spain

Location

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Universitätsspital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

Location

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Charing Cross Hospital

London, United Kingdom

Location

Related Links

• Click here to find results for studies related to Bayer products.
• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 31, 2017
• Study Start: September 29, 2017
• Primary Completion: May 24, 2018
• Study Completion: May 24, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

NO (1); CZ (4); PT (1); FI (2); SE (1); HU (4); AU (2); DK (1); FR (5); CH (2); PL (5); GB (4); ES (6); BE (4); IT (5); IL (1); CA (3); DE (10)