check_circleStudy Completed
Multiple sclerosis
Bayer Identifier:
91031
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
BENEFIT study (Betaferon® / Betaseron® in newly emerging multiple sclerosis for initial treatment) and BENEFIT Follow-up Study
Trial purpose
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.
Key Participants Requirements
Sex
BothAge
18 - 48 YearsTrial summary
Enrollment Goal
468Trial Dates
August 2002 - May 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsspital Basel | Basel, 4031, Switzerland |
Completed | Hospitais da Universidade de Coimbra | Coimbra, 3000, Portugal |
Completed | Fakultni nemocnice | Hradec Kralove, 50005, Czech Republic |
Completed | Vivantes Klinikum Spandau | Berlin, 13585, Germany |
Completed | Ciutat Sanitària i Universitària de Bellvitge | Hospitalet de Llobregat, 08907, Spain |
Completed | Oulun yliopisto | Oulu, 90029, Finland |
Completed | Hopital general | Dijon, 21033, France |
Completed | Kantonsspital St. Gallen | St. Gallen, 9007, Switzerland |
Completed | Fakultni nemocnice s poliklinikou Ostrava | Ostrava, 70852, Czech Republic |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Completed | Hopital Roger Salengro | Lille, 59037, France |
Completed | Ottawa Hospital-General Campus | Ottawa, K1H 8L6, Canada |
Completed | Neurolocicka klinika - MS centrum | Prag, 12808, Czech Republic |
Completed | Hospital de Cruces | Barakaldo, 48903, Spain |
Completed | Postitalon lääkäriasema | Helsinki, 00100, Finland |
Completed | Jahn Ferenc Hospital | Budapest, 1204, Hungary |
Completed | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | CU Saint-Luc/UZ St-Luc | Bruxelles, 1200, Belgium |
Completed | Fakultni nemocnice Brno | Brno, 63900, Czech Republic |
Completed | Krankenhaus Hennigsdorf | Hennigsdorf, 16761, Germany |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Completed | Suomen Erikoisneurologiakeskus Oy | Turku, 20100, Finland |
Completed | Hospital Pellegrin | Bordeaux, 33076, France |
Completed | Aberdeen Royal Infirmary | Aberdeen, AB25 2ZN, United Kingdom |
Completed | Uzsoki utkai Korhaz | Budapest, 1145, Hungary |
Completed | Haukeland universitetssjukehus, Bergen | Bergen, N-5021, Norway |
Completed | Szpital Uniwersytecki w Krakowie | Krakow, 31503, Poland |
Completed | Sahlgrenska Universitetssjukhuset | Göteborg, 41685, Sweden |
Completed | Klinicni center | Lubljana, 1525, Slovenia |
Completed | Universitätsklinikum Innsbruck | Innsbruck, 6020, Austria |
Completed | Amtssygehuset Glostrup | Glostrup, 2600, Denmark |
Completed | University of Debrecen Medical&Health Science Center | Debrecen, 4032, Hungary |
Completed | Ospedale Sant'Antonio Abate | Gallarate, 21013, Italy |
Completed | SP Szpital Kliniczny nr 5 | Wroclaw, 50420, Poland |
Completed | Fakultni nemocnice Kralovske Vinohrady | Prag, 10034, Czech Republic |
Completed | Hospital Clínico Universitario San Carlos | Madrid, 28040, Spain |
Completed | Peterfy Sandor utcai Korhaz - Rendelointezet | Budapest, 1076, Hungary |
Completed | Kuopion yliopistollinen sairaala | Kuopio, 70210, Finland |
Terminated | Centre hospitalier universitaire | nancy, 54035, France |
Completed | St. Elisabeth Ziekenhuis | Tilburg, 5022 GC, Netherlands |
Completed | UZ Gent | Gent, 9000, Belgium |
Completed | Foothills Medical Centre | Calgary, T2N 2T9, Canada |
Completed | Hospital Regional Carlos Haya | Malaga, 29010, Spain |
Completed | C. H. U. Hopital Purpan | Toulouse, 31059, France |
Completed | Medizinische Einrichtungen der Heinrich-Heine-Universität | Düsseldorf, 40225, Germany |
Completed | Centre hospitalier universitaire | nice, 06000, France |
Completed | Fondations rothshild | PARIS, 75019, France |
Completed | Universitätsmedizin der Georg-August-Universität Göttingen | Göttingen, 37099, Germany |
Completed | Carmel Medical Center | Haifa, 34362, Israel |
Completed | Szpital im. N. Barlickiego | Lodz, 90153, Poland |
Completed | Allgemeines Krankenhaus der Stadt Wien Universitätskliniken | Wien, 1090, Austria |
Completed | UZ Leuven Gasthuisberg | Leuven, 3000, Belgium |
Completed | CHUM - Hopital Notre-Dame | Montreal, H2L 4M1, Canada |
Completed | Klinikum der Ernst-Moritz-Arndt-Universität | Greifswald, 17475, Germany |
Completed | Seinäjoen keskussairaala | Seinäjoki, 60220, Finland |
Completed | Charing Cross Hospital | London, W6 8RF, United Kingdom |
Completed | Szeged University Medical School | Szeged, 6720, Hungary |
Completed | Sheba Medical Center | Tel Hashomer, 52621, Israel |
Completed | Samodzielny Publiczny Szpital Kliniczny nr 4 | Lublin, 20090, Poland |
Completed | CHU de Liège | Liège 1, 4000, Belgium |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Completed | HELIOS Klinikum Erfurt GmbH | Erfurt, 99089, Germany |
Completed | Tampereen yliopistollinen sairaala, keskussairaala | Tampere, 33521, Finland |
Completed | Ninewells Hospital and Medical School | Dundee, DD1 9SY, United Kingdom |
Completed | Universitätskliniken des Saarlandes | Homburg, 66424, Germany |
Completed | Johannes-Gutenberg-Universität Mainz | Mainz, 55101, Germany |
Completed | LMU Klinikum der Universität München - Großhadern | München, 81377, Germany |
Completed | Universitätsklinikum Regensburg | Regensburg, 93053, Germany |
Completed | Universitätsklinikum Ulm | Ulm, 89081, Germany |
Completed | Klinikum der Universität Würzburg | Würzburg, 97080, Germany |
Completed | Klinikum Offenbach | Offenbach, 63069, Germany |
Completed | Orbis Medisch Centrum | Sittard, 6131 BK, Netherlands |
Completed | 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ | Bydgoszcz, 85681, Poland |
Completed | Fakultni nemocnice Plzen | Plzen, 30460, Czech Republic |
Completed | Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle, 06120, Germany |
Completed | The Royal Hallamshire Hospital | Sheffield, S10 2JF, United Kingdom |
Completed | University of British Columbia Hospital | Vancouver, V6T 2B5, Canada |
Completed | Hospital Universitario Virgen de la Macarena | Sevilla, 41071, Spain |
Completed | Hopital Pontchaillou | Rennes, 35038, France |
Completed | Ospedale San Raffaele | Milano, 20132, Italy |
Completed | London Health Sciences Centre | London, N6A 5A5, Canada |
Completed | Städtisches Klinikum Braunschweig gGmbH | Braunschweig, 38126, Germany |
Completed | Hospital Universitari i Politècnic La Fe | Valencia, 46026, Spain |
Completed | St. Michael's Hospital Health Centre | Toronto, M5B 1W8, Canada |
Completed | Hopital gabriel montpied | Clermont ferrand, 63003, France |
Completed | A.O. di Padova | Padova, 35128, Italy |
Completed | discontinued | Pavia, 27100, Italy |
Completed | Universitätsklinikum Giessen und Marburg | Gießen, 35392, Germany |
Completed | Università di Torino | Torino, 10126, Italy |
Completed | Universitätsklinikum Köln | Köln, 50931, Germany |
Completed | Otto-von-Guericke-Universität Magdeburg | Magdeburg, 39120, Germany |
Completed | Universitätsklinik Gießen und Marburg GmbH | Marburg, 35039, Germany |
Completed | Marien-Hospital | Düsseldorf, 40479, Germany |
Completed | Universitätsklinikum Münster | Münster, 48149, Germany |
Primary Outcome
- Time to Clinically Definite Multiple Sclerosis (CDMS) represented by Kaplan-Meier estimates of the cumulative percentage of participants with CDMS at selected points in timedate_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Timedate_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60date_rangeTime Frame:60 months after start of treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteriadate_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapsesdate_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- Relapse-based Efficacy Domain (Supportive): Annualized Relapse Ratedate_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60date_rangeTime Frame:60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60date_rangeTime Frame:up to 60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60date_rangeTime Frame:60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60date_rangeTime Frame:60 months after start of treatmentenhanced_encryptionNoSafety Issue:
- MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60date_rangeTime Frame:60 months after start of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2