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

NCT ID: NCT00459667

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-03-31

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.

Detailed Description

Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer 306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned study medication, applying the same level of blinding as during the BEYOND study, All patients randomized during the BEYOND study to Copaxone and all patients with premature discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b 250µg.

Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

Randomization: No randomization in this trial, patient's allocation in this follow-up study depends only on prior trial groups. The preceding study was randomized.

The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer HealthCare Pharmaceuticals Inc.

Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The variables FAMS and EQ-5D were not analyzed due to the termination of the study before start of Phase B.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IFNB-1b 500 mcg

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Phase A: 500ug 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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*

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.)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).

Interventions

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

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).

Intervention Type: DRUG

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

Phase A: 500ug 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).

Intervention Type: DRUG

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

Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.

Phase B: All patients will receive 500µg s.c.every other day (open-label).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 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

Birmingham, Alabama, United States

Cullman, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Berkeley, California, United States

La Jolla, California, United States

Sacramento, California, United States

San Francisco, California, United States

Fort Collins, Colorado, United States

Newark, Delaware, United States

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

Maitland, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Augusta, Georgia, United States

Chicago, Illinois, United States

Fort Wayne, Indiana, United States

Indianapolis, Indiana, United States

Des Moines, Iowa, United States

Kansas City, Kansas, United States

Louisville, Kentucky, United States

Shreveport, Louisiana, United States

Detroit, Michigan, United States

Duluth, Minnesota, United States

St Louis, Missouri, United States

Henderson, Nevada, United States

Reno, Nevada, United States

Newark, New Jersey, United States

Albuquerque, New Mexico, United States

Mineola, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Tualatin, Oregon, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

Charleston, South Carolina, United States

Nashville, Tennessee, United States

Houston, Texas, United States

San Antonio, Texas, United States

Fairfax, Virginia, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Milwaukee, Wisconsin, United States

Buenos Aires, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

Rosario, Santa Fe Province, Argentina

Kogarah, New South Wales, Australia

Fitzroy, Victoria, Australia

Parkville, Victoria, Australia

Nedlands, Western Australia, Australia

Liverpool, , Australia

Wyoming, , Australia

Sankt Pölten, Lower Austria, Austria

Graz, , Austria

Innsbruck, , Austria

Linz, , Austria

Brussels, , Belgium

Leuven, , Belgium

Melsbroek, , Belgium

Curitiba, Paraná, Brazil

Recife, Pernambuco, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Campinas, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Halifax, Nova Scotia, Canada

London, Ontario, Canada

Mississauga, Ontario, Canada

Nepean, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Greenfield Park, Quebec, Canada

Hull, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Aarhus, , Denmark

Oulu, , Finland

Tampere, , Finland

Rennes, Brittany Region, France

Bordeaux, Gironde, France

Clermont-Ferrand, , France

Dijon, , France

Lille, , France

Nancy, , France

Nantes, , France

Nice, , France

Nîmes, , France

Toulouse, , France

Heidelberg, Baden-Wurttemberg, Germany

Bayreuth, Bavaria, Germany

Regensburg, Bavaria, Germany

Hennigsdorf, Brandenburg, Germany

Hamburg, City state of Hamburg, Germany

Hamburg, City state of Hamburg, Germany

Giessen, Hesse, Germany

Marburg, Hesse, Germany

Offenbach, Hesse, Germany

Göttingen, Lower Saxony, Germany

Hanover, Lower Saxony, Germany

Hanover, Lower Saxony, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Halle, Saxony-Anhalt, Germany

Berlin, State of Berlin, Germany

Berlin, State of Berlin, Germany

Athens, Attica, Greece

Thessaloniki, , Greece

Budapest, , Hungary

Budapest, , Hungary

Győr, , Hungary

Miskolc, , Hungary

Pécs, , Hungary

Zalaegerszeg-Pozva, , Hungary

Dublin, Dublin, Ireland

Cork, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Tel Aviv, Israel, Israel

Tel Litwinsky, Israel, Israel

Ẕerifin, Israel, Israel

Ashkelon, , Israel

Haifa, , Israel

Jerusalem, , Israel

Orbassano, Torino, Italy

Bari, , Italy

Florence, , Italy

Milan, , Italy

Padua, , Italy

Roma, , Italy

Riga, , Latvia

Breda, , Netherlands

Nijmegen, , Netherlands

Sittard, , Netherlands

Bergen, , Norway

Gdansk, , Poland

Katowice, , Poland

Lodz, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Moskva, , Russia

Moskva, , Russia

Moskva, , Russia

Moskva, , Russia

Moskva, , Russia

Nizhy Novgorod, , Russia

Novosibirsk, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Ljubljana, , Slovenia

Maribor, , Slovenia

L'Hospitalet de Llobregat, Barcelona, Spain

Málaga, , Spain

Seville, , Spain

Stockholm, , Sweden

Uppsala, , Sweden

Bern, , Switzerland

Sankt Gallen, , Switzerland

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; Denmark; Finland; France; Germany; Greece; Hungary; Ireland; Israel; Italy; Latvia; Netherlands; Norway; Poland; Russia; Slovenia; Spain; Sweden; Switzerland; Ukraine

References

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.

Reference Type: DERIVED

PMID: 21952094 (View on PubMed)

Other Identifiers

2006-005270-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

309363

Identifier Type: OTHER

Identifier Source: secondary_id

91656

Identifier Type: -

Identifier Source: org_study_id