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

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

Sponsors

Lead Sponsor: Bayer

Source 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.

Overall Status Completed
Start Date September 29, 2017
Completion Date May 24, 2018
Primary Completion Date May 24, 2018
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure 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 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) 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) 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 Outcome
Measure Time Frame
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
Functional Assessment of Multiple Sclerosis (FAMS score) Over 15 years since the subject´s first clinical event
Fatigue Scale for Motor and Cognitive Functions (FSMC score) 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
Time to second line therapy Over 15 years since the subject´s first clinical event
Time to first disease-modifying therapies (DMT) other than IFNB-1b Over 15 years since the subject´s first clinical event
Enrollment 261
Condition
Intervention

Intervention Type: Other

Intervention Name: Brain MRI

Description: Brain MRI will be performed

Intervention Type: Other

Intervention Name: Blood sampling

Description: Blood samples will be taken

Eligibility

Criteria:

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

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

Austria

Belgium

Canada

Czechia

Denmark

Finland

France

Germany

Hungary

Israel

Italy

Norway

Poland

Portugal

Spain

Sweden

Switzerland

United Kingdom

Verification Date

May 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental arm 15 years ago

Type: Other

Description: This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Label: Placebo arm, offered treatment at MS diagnosis or at Month 24

Type: Other

Description: This long term study does not imply current study medication. It looks at the status 15 years after the clinicial trial (BENEFIT)

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov