BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

NCT00459667 | Completed Phase 3 Results

• 3 other identifiers: 916562006-005270-47309363
• Study Type: interventional
• Target: 1,420
• Locations: 25 countries
• Sites: 180

Brief Summary

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron

Outcome Measures

Primary Outcomes (4)

• Flu-like-syndrome

  The variable "Flu-like-syndrome" will consist of a combination of MedDRA terms (Preferred Terms and Lower Level Terms) indicative for this condition.

  309 days

• Injection-site Reactions

  The variable "Injection-site reactions" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

  309 days

• Liver Enzyme Elevations

  The variable "Liver enzyme elevations" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

  309 days

• Hematological Abnormalities

  The variable "Hematological abnormalities" will consist of a combination of MedDRA terms (Preferred Terms only) indicative for this condition.

  309 days

Secondary Outcomes (1)

• Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values

  309 days

Study Arms (3)

IFNB-1b 500 mcg

EXPERIMENTAL

Interferon beta 1b (\[IFNB 1b\] Betaseron) 500 mcg administered s.c. every other day (double blind)

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

IFNB-1b 250 mcg

EXPERIMENTAL

Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day (double blind)

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

IFNB-1b 250 mcg*

EXPERIMENTAL

Interferon beta 1b (\[IFNB 1b\] Betaseron) 250 mcg administered s.c. every other day \*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)

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

Interventions

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

Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).

IFNB-1b 250 mcg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completion of the BEYOND study 306440 as scheduled
• Relapsing multiple sclerosis
• Medical assessment by the investigator that there is no objection to the patient's participation in this trial considering the medical experience from study 306440. Special attention should be given to laboratory abnormalities and clinically relevant liver, renal and bone-marrow dysfunction.
• Females of child-bearing potential:
• Agreement to practice adequate contraception methods and
• Negative pregnancy test and
• No lactation
• Written informed consent

You may not qualify if:

• Serious or acute heart diseases
• History of severe depression or suicide attempt
• Epilepsy not adequately controlled by treatment
• Known allergy to IFNs, to human albumin or to mannitol
• Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study

Sponsors & Collaborators

• Bayer: lead

Study Sites (184)

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Birmingham, Alabama, 35294-7340, United States

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Cullman, Alabama, 35058, United States

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Phoenix, Arizona, 85013, United States

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Tucson, Arizona, 85741, United States

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Berkeley, California, 94705, United States

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La Jolla, California, 92037, United States

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Sacramento, California, 95817, United States

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San Francisco, California, 94117, United States

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Fort Collins, Colorado, 80528, United States

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Newark, Delaware, 19713, United States

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Washington D.C., District of Columbia, 20037, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33136, United States

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Tampa, Florida, 33606, United States

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Tampa, Florida, 33609, United States

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Atlanta, Georgia, 30309-1465, United States

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Augusta, Georgia, 30912, United States

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Chicago, Illinois, 60637, United States

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Fort Wayne, Indiana, 46805, United States

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Indianapolis, Indiana, 46202, United States

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Des Moines, Iowa, 50314, United States

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Kansas City, Kansas, 66160, United States

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Louisville, Kentucky, 40202, United States

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Shreveport, Louisiana, 71130, United States

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Detroit, Michigan, 48202, United States

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Duluth, Minnesota, 55805, United States

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St Louis, Missouri, 63110, United States

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Henderson, Nevada, 89052, United States

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Reno, Nevada, 89509, United States

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Newark, New Jersey, 07103, United States

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Albuquerque, New Mexico, 87131-5281, United States

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Mineola, New York, 11501, United States

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Rochester, New York, 14642, United States

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Stony Brook, New York, 11794, United States

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Charlotte, North Carolina, 28207, United States

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Durham, North Carolina, 27710, United States

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Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45219, United States

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Columbus, Ohio, 43210, United States

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Tualatin, Oregon, 97062, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Providence, Rhode Island, 02905, United States

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Charleston, South Carolina, 29425, United States

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Nashville, Tennessee, 37205, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Fairfax, Virginia, 22031, United States

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Seattle, Washington, 98101, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53215, United States

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Buenos Aires, Buenos Aires, C1416CRJ, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1117ABE, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB, Argentina

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Córdoba, Córdoba Province, X5000HGX, Argentina

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Rosario, Santa Fe Province, S2000ZBL, Argentina

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Rosario, Santa Fe Province, Argentina

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Kogarah, New South Wales, 2217, Australia

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Fitzroy, Victoria, 3065, Australia

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Parkville, Victoria, 3050, Australia

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Nedlands, Western Australia, 6009, Australia

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Liverpool, NSW 2170, Australia

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Wyoming, NSW 2250, Australia

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Sankt Pölten, Lower Austria, A-3100, Austria

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Linz, 4020, Austria

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Brussels, 1090, Belgium

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Leuven, 3000, Belgium

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Melsbroek, 1820, Belgium

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Curitiba, Paraná, 80240-340, Brazil

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Recife, Pernambuco, 52010-040, Brazil

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Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

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Campinas, São Paulo, 13081- 970, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 04039-032, Brazil

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São Paulo, São Paulo, 05403-900, Brazil

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, V6T 2B5, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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London, Ontario, N6A 5A5, Canada

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Mississauga, Ontario, L5B 1B8, Canada

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Nepean, Ontario, K2G 6E2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Hull, Quebec, J8Y 1W7, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Aarhus, 8000, Denmark

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Oulu, 90029, Finland

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Tampere, 33521, Finland

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Rennes, Brittany Region, 35038, France

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Bordeaux, Gironde, 33076, France

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Clermont-Ferrand, 63003, France

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Dijon, 21033, France

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Lille, 59037, France

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Nancy, 54035, France

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Nantes, 44093, France

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Nice, 06000, France

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Nîmes, 30029, France

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Toulouse, 31059, France

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Bayreuth, Bavaria, 95445, Germany

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Regensburg, Bavaria, 93053, Germany

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Hennigsdorf, Brandenburg, 16761, Germany

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Hamburg, Hamburg, 20099, Germany

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Hamburg, Hamburg, 20246, Germany

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Giessen, Hesse, 35392, Germany

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Marburg, Hesse, 35039, Germany

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Offenbach, Hesse, 63069, Germany

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Göttingen, Lower Saxony, 37099, Germany

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Hanover, Lower Saxony, 30559, Germany

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Hanover, Lower Saxony, 30625, Germany

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Greifswald, Mecklenburg-Vorpommern, 17475, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Essen, North Rhine-Westphalia, 45117, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04129, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Berlin, State of Berlin, 13347, Germany

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Berlin, State of Berlin, 13585, Germany

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Athens, Attica, 11527, Greece

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Thessaloniki, 54636, Greece

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Budapest, 1076, Hungary

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Budapest, 1145, Hungary

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Győr, 9024, Hungary

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Miskolc, 3501, Hungary

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Pécs, 7623, Hungary

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Zalaegerszeg-Pozva, H-8900, Hungary

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Dublin, Dublin, Ireland

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Cork, Ireland

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Dublin, 4, Ireland

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Dublin, 9, Ireland

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Tel Aviv, Israel, 64239, Israel

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Tel Litwinsky, Israel, 52621, Israel

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Ẕerifin, Israel, 70300, Israel

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Ashkelon, 78278, Israel

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Haifa, 31048, Israel

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Jerusalem, 91120, Israel

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Orbassano, Torino, 10043, Italy

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Bari, 70122, Italy

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Florence, 50134, Italy

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Milan, 20132, Italy

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Padua, 35128, Italy

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Roma, 00189, Italy

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Riga, LV-1015, Latvia

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Breda, 4819 EV, Netherlands

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Nijmegen, 6533 PA, Netherlands

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Sittard, 6131 BK, Netherlands

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Bergen, N-5021, Norway

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Gdansk, 80-803, Poland

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Katowice, 40752, Poland

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Lodz, 90153, Poland

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Poznan, 61848, Poland

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Warsaw, 02097, Poland

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Warsaw, 02957, Poland

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Wroclaw, 50420, Poland

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Moskva, 117049, Russia

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Moskva, 118089, Russia

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Moskva, 123367, Russia

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Moskva, 127018, Russia

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Moskva, 129110, Russia

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Nizhy Novgorod, 603076, Russia

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Novosibirsk, 630007, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197376, Russia

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Yaroslavl, 150039, Russia

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Ljubljana, SI-1525, Slovenia

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Maribor, 2000, Slovenia

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Málaga, 29010, Spain

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Seville, 41071, Spain

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Stockholm, 182 88, Sweden

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Uppsala, 751 85, Sweden

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Bern, 3010, Switzerland

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Sankt Gallen, 9007, Switzerland

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Donetsk, 83003, Ukraine

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Kharkiv, 61068, Ukraine

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Kiev, 03110, Ukraine

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Lviv, 79000, Ukraine

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Related Publications (1)

• Goodin DS, Hartung HP, O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Jeffery D, Kappos L, Bogumil T, Knappertz V, Sandbrink R, Beckmann K, White R, Petkau J, Pohl C; BEYOND Study Group. Neutralizing antibodies to interferon beta-1b multiple sclerosis: a clinico-radiographic paradox in the BEYOND trial. Mult Scler. 2012 Feb;18(2):181-95. doi: 10.1177/1352458511418629. Epub 2011 Sep 27.

  PMID: 21952094 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Due to the termination of the study before start of Phase B according to protocol defined stopping rules, functional assessments of multiple sclerosis (FAMS) and EuroQoL (EQ-5D) were not performed.

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 12, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 23, 2015
• Results First Posted: August 17, 2009

Record last verified: 2015-04

Locations

LA (1); IL (6); BE (3); FR (10); ES (3); BR (8); DE (21); RU (11); HU (6); AR (6); IE (4); GR (2); FI (2); CA (12); US (51); AU (6); IT (6); NL (3); SL (2); CH (2); UA (4); DK (1); NO (1); PL (7); SE (2)