Trial Condition(s):
Multiple Sclerosis
BENEFIT study (Betaferon® / Betaseron® in newly emerging multiple sclerosis for initial treatment) and BENEFIT Follow-up Study
Bayer Identifier:
91031
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months
Exclusion Criteria
- No participation in the initial BENEFIT study
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospitais da Universidade de Coimbra Coimbra, Portugal, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Hradec Kralove, Czech Republic, 50005 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vivantes Klinikum Spandau Berlin, Germany, 13585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitària de Bellvitge Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oulun yliopisto Oulu, Finland, 90029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital general Dijon, France, 21033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital St. Gallen St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice s poliklinikou Ostrava Ostrava, Czech Republic, 70852 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Roger Salengro Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Neurolocicka klinika - MS centrum Prag, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Cruces Barakaldo, Spain, 48903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Postitalon lääkäriasema Helsinki, Finland, 00100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jahn Ferenc Hospital Budapest, Hungary, 1204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc Bruxelles, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 63900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus Hennigsdorf Hennigsdorf, Germany, 16761 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Suomen Erikoisneurologiakeskus Oy Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Pellegrin Bordeaux, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uzsoki utkai Korhaz Budapest, Hungary, 1145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haukeland universitetssjukehus, Bergen Bergen, Norway, N-5021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 31503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 41685 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinicni center Lubljana, Slovenia, 1525 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Amtssygehuset Glostrup Glostrup, Denmark, 2600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Sant'Antonio Abate Gallarate, Italy, 21013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SP Szpital Kliniczny nr 5 Wroclaw, Poland, 50420 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Kralovske Vinohrady Prag, Czech Republic, 10034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peterfy Sandor utcai Korhaz - Rendelointezet Budapest, Hungary, 1076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kuopion yliopistollinen sairaala Kuopio, Finland, 70210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre hospitalier universitaire nancy, France, 54035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Elisabeth Ziekenhuis Tilburg, Netherlands, 5022 GC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Gent Gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Foothills Medical Centre Calgary, Canada, T2N 2T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Malaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations C. H. U. Hopital Purpan Toulouse, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Heinrich-Heine-Universität Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre hospitalier universitaire nice, France, 06000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fondations rothshild PARIS, France, 75019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Carmel Medical Center Haifa, Israel, 34362 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital im. N. Barlickiego Lodz, Poland, 90153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg Leuven, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUM - Hopital Notre-Dame Montreal, Canada, H2L 4M1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seinäjoen keskussairaala Seinäjoki, Finland, 60220 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charing Cross Hospital London, United Kingdom, W6 8RF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szeged University Medical School Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sheba Medical Center Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHU de Liège Liège 1, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HELIOS Klinikum Erfurt GmbH Erfurt, Germany, 99089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tampereen yliopistollinen sairaala, keskussairaala Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ninewells Hospital and Medical School Dundee, United Kingdom, DD1 9SY | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätskliniken des Saarlandes Homburg, Germany, 66424 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Regensburg Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Ulm Ulm, Germany, 89081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Universität Würzburg Würzburg, Germany, 97080 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Offenbach Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orbis Medisch Centrum Sittard, Netherlands, 6131 BK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Bydgoszcz, Poland, 85681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Plzen Plzen, Czech Republic, 30460 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Royal Hallamshire Hospital Sheffield, United Kingdom, S10 2JF | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of British Columbia Hospital Vancouver, Canada, V6T 2B5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen de la Macarena Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Pontchaillou Rennes, France, 35038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Health Sciences Centre London, Canada, N6A 5A5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Braunschweig gGmbH Braunschweig, Germany, 38126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Michael's Hospital Health Centre Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital gabriel montpied Clermont ferrand, France, 63003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations discontinued Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Giessen und Marburg Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Torino Torino, Italy, 10126 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50931 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Otto-von-Guericke-Universität Magdeburg Magdeburg, Germany, 39120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marien-Hospital Düsseldorf, Germany, 40479 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Münster Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, multi-center phase III extension of the double-blind, placebo-controlled BENEFIT study (no. 92012/304747) to obtain long-term follow-up data of patients with clinically definite multiple sclerosis (MS) and patients with a first demyelinating event suggestive of MS treated with 8 MIU (250 µg) interferon beta-1b (Betaferon® / Betaseron®) given subcutaneously every other day for at least 36 months.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
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 timeTimeframe: up to 60 months after start of treatment
- 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 TimeTimeframe: up to 60 months after start of treatment
- Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60Timeframe: 60 months after start of treatment
Secondary Outcome
- Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald CriteriaTimeframe: up to 60 months after start of treatment
- Relapse-based Efficacy Domain: Hazard Ratio for Recurrent RelapsesTimeframe: up to 60 months after start of treatment
- Relapse-based Efficacy Domain (Supportive): Annualized Relapse RateTimeframe: up to 60 months after start of treatment
- Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60Timeframe: 60 months after start of treatment
- MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60Timeframe: up to 60 months after start of treatment
- MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60Timeframe: 60 months after start of treatment
- MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60Timeframe: 60 months after start of treatment
- MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60Timeframe: 60 months after start of treatment
Additional Information
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