BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study

NCT ID: NCT00185211

Last Updated: 2013-12-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2008-05-31

Brief Summary

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.

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc..

Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial IFNB-1b (Interferon beta-1b)

Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase

Group Type: EXPERIMENTAL

Interferon beta-1b (Betaseron, BAY86-5046)

Intervention Type: DRUG

Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase

Initial Placebo

Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)

Group Type: EXPERIMENTAL

Interferon beta-1b (Betaseron, BAY86-5046)

Intervention Type: DRUG

Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)

Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase

Intervention Type: DRUG

Interferon beta-1b (Betaseron, BAY86-5046)

Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Graz, , Austria

Innsbruck, , Austria

Vienna, , Austria

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Brno, , Czechia

Hradec Králové, , Czechia

Ostrava, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Prague, , Czechia

Glostrup Municipality, , Denmark

Helsinki, , Finland

Kuopio, , Finland

Oulu, , Finland

Seinäjoki, , Finland

Tampere, , Finland

Turku, , Finland

Rennes, Brittany Region, France

Bordeaux, Gironde, France

Clermont-Ferrand, , France

Dijon, , France

Lille, , France

Nancy, , France

Nice, , France

Paris, , France

Toulouse, , France

Ulm, Baden-Wurttemberg, Germany

München, Bavaria, Germany

Regensburg, Bavaria, Germany

Würzburg, Bavaria, Germany

Hennigsdorf, Brandenburg, Germany

Giessen, Hesse, Germany

Marburg, Hesse, Germany

Offenbach, Hesse, Germany

Braunschweig, Lower Saxony, Germany

Göttingen, Lower Saxony, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Cologne, North Rhine-Westphalia, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Homburg, Saarland, Germany

Halle, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Erfurt, Thuringia, Germany

Szeged, Csongrád megye, Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Haifa, Israel, Israel

Tel Litwinsky, Israel, Israel

Gallarate, Varese, Italy

Milan, , Italy

Padua, , Italy

Pavia, , Italy

Torino, , Italy

Sittard, , Netherlands

Tilburg, , Netherlands

Bergen, , Norway

Bydgoszcz, , Poland

Krakow, , Poland

Lodz, , Poland

Lublin, , Poland

Wroclaw, , Poland

Coimbra, , Portugal

Ljubljana, , Slovenia

L'Hospitalet de Llobregat, Barcelona, Spain

Barakaldo, Vizcaya, Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

Málaga, , Spain

Seville, , Spain

Valencia, , Spain

Gothenburg, , Sweden

Basel, Canton of Basel-City, Switzerland

Sankt Gallen, , Switzerland

Dundee, Scotland, United Kingdom

Aberdeen, , United Kingdom

London, , United Kingdom

Sheffield, , United Kingdom

Countries

Austria; Belgium; Canada; Czechia; Denmark; Finland; France; Germany; Hungary; Israel; Italy; Netherlands; Norway; Poland; Portugal; Slovenia; Spain; Sweden; Switzerland; United Kingdom

References

Edan G, Kappos L, Montalban X, Polman CH, Freedman MS, Hartung HP, Miller D, Barkhof F, Herrmann J, Lanius V, Stemper B, Pohl C, Sandbrink R, Pleimes D; BENEFIT Study Group. Long-term impact of interferon beta-1b in patients with CIS: 8-year follow-up of BENEFIT. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1183-9. doi: 10.1136/jnnp-2013-306222. Epub 2013 Nov 11.

Reference Type: BACKGROUND

PMID: 24218527 (View on PubMed)

Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

Reference Type: BACKGROUND

PMID: 23842212 (View on PubMed)

Penner IK, Stemper B, Calabrese P, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Pleimes D, Lanius V, Pohl C, Kappos L, Sandbrink R. Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis. Mult Scler. 2012 Oct;18(10):1466-71. doi: 10.1177/1352458512442438. Epub 2012 Apr 4.

Reference Type: BACKGROUND

PMID: 22492127 (View on PubMed)

Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.

Reference Type: RESULT

PMID: 19748319 (View on PubMed)

Hartung HP, Freedman MS, Polman CH, Edan G, Kappos L, Miller DH, Montalban X, Barkhof F, Petkau J, White R, Sahajpal V, Knappertz V, Beckmann K, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Interferon beta-1b-neutralizing antibodies 5 years after clinically isolated syndrome. Neurology. 2011 Aug 30;77(9):835-43. doi: 10.1212/WNL.0b013e31822c90d7. Epub 2011 Aug 17.

Reference Type: RESULT

PMID: 21849647 (View on PubMed)

Freedman MS, Metzig C, Kappos L, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Yarden J, Spector L, Fire E, Dotan N, Schwenke S, Lanius V, Sandbrink R, Pohl C. Predictive nature of IgM anti-alpha-glucose serum biomarker for relapse activity and EDSS progression in CIS patients: a BENEFIT study analysis. Mult Scler. 2012 Jul;18(7):966-73. doi: 10.1177/1352458511432327. Epub 2011 Dec 19.

Reference Type: RESULT

PMID: 22183938 (View on PubMed)

Waschbisch A, Sandbrink R, Hartung HP, Kappos L, Schwab S, Pohl C, Wiendl H. Evaluation of soluble HLA-G as a biomarker for multiple sclerosis. Neurology. 2011 Aug 9;77(6):596-8. doi: 10.1212/WNL.0b013e318228c14d. Epub 2011 Jul 27. No abstract available.

Reference Type: RESULT

PMID: 21795647 (View on PubMed)

Moraal B, Pohl C, Uitdehaag BM, Polman CH, Edan G, Freedman MS, Hartung HP, Kappos L, Miller DH, Montalban X, Lanius V, Sandbrink R, Barkhof F. Magnetic resonance imaging predictors of conversion to multiple sclerosis in the BENEFIT study. Arch Neurol. 2009 Nov;66(11):1345-52. doi: 10.1001/archneurol.2009.243.

Reference Type: RESULT

PMID: 19901165 (View on PubMed)

Polman C, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Selmaj K, Uitdehaag BM, Dahms S, Bauer L, Pohl C, Sandbrink R; BENEFIT investigators. Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. J Neurol. 2008 Apr;255(4):480-7. doi: 10.1007/s00415-007-0733-2. Epub 2007 Nov 15.

Reference Type: RESULT

PMID: 18004635 (View on PubMed)

Caloyeras JP, Zhang B, Wang C, Eriksson M, Fredrikson S, Beckmann K, Knappertz V, Pohl C, Hartung HP, Shah D, Miller JD, Sandbrink R, Lanius V, Gondek K, Russell MW. Cost-effectiveness analysis of interferon beta-1b for the treatment of patients with a first clinical event suggestive of multiple sclerosis. Clin Ther. 2012 May;34(5):1132-44. doi: 10.1016/j.clinthera.2012.03.004. Epub 2012 Apr 27.

Reference Type: RESULT

PMID: 22541587 (View on PubMed)

Nielsen JM, Pohl C, Polman CH, Barkhof F, Freedman MS, Edan G, Miller DH, Bauer L, Sandbrink R, Kappos L, Uitdehaag BM. MRI characteristics are predictive for CDMS in monofocal, but not in multifocal patients with a clinically isolated syndrome. BMC Neurol. 2009 May 20;9:19. doi: 10.1186/1471-2377-9-19.

Reference Type: RESULT

PMID: 19457248 (View on PubMed)

Barkhof F, Polman CH, Radue EW, Kappos L, Freedman MS, Edan G, Hartung HP, Miller DH, Montalban X, Poppe P, de Vos M, Lasri F, Bauer L, Dahms S, Wagner K, Pohl C, Sandbrink R. Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. Arch Neurol. 2007 Sep;64(9):1292-8. doi: 10.1001/archneur.64.9.1292.

Reference Type: RESULT

PMID: 17846268 (View on PubMed)

Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Bauer L, Dahms S, Lanius V, Pohl C, Sandbrink R; BENEFIT Study Group. Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: a 3-year follow-up analysis of the BENEFIT study. Lancet. 2007 Aug 4;370(9585):389-97. doi: 10.1016/S0140-6736(07)61194-5.

Reference Type: RESULT

PMID: 17679016 (View on PubMed)

De Jager PL, Chibnik LB, Cui J, Reischl J, Lehr S, Simon KC, Aubin C, Bauer D, Heubach JF, Sandbrink R, Tyblova M, Lelkova P; Steering committee of the BENEFIT study; Steering committee of the BEYOND study; Steering committee of the LTF study; Steering committee of the CCR1 study; Havrdova E, Pohl C, Horakova D, Ascherio A, Hafler DA, Karlson EW. Integration of genetic risk factors into a clinical algorithm for multiple sclerosis susceptibility: a weighted genetic risk score. Lancet Neurol. 2009 Dec;8(12):1111-9. doi: 10.1016/S1474-4422(09)70275-3. Epub 2009 Oct 29.

Reference Type: RESULT

PMID: 19879194 (View on PubMed)

Other Identifiers

305207

Identifier Type: OTHER

Identifier Source: secondary_id

91031

Identifier Type: -

Identifier Source: org_study_id