check_circleStudy Completed

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

91656

ClinicalTrials.gov Identifier:

NCT00459667

EudraCT Number:

2006-005270-47

EU CT Number:

Not Available
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
1420
Trial Dates
May 2007 - March 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Graz, 8036, Austria
Withdrawn
Milwaukee, 53215, United States
Completed
Tualatin, 97062, United States
Completed
Birmingham, 35294-7340, United States
Completed
Reno, 89509, United States
Completed
Duluth, 55805, United States
Withdrawn
St. Louis, 63110, United States
Completed
Newark, 07103, United States
Completed
Tucson, 85741, United States
Completed
Stony Brook, 11794, United States
Completed
Detroit, 48202, United States
Completed
Albuquerque, 87131-5281, United States
Completed
Fort Wayne, 46805, United States
Completed
Des Moines, 50314, United States
Withdrawn
Augusta, 30912, United States
Completed
Sacramento, 95817, United States
Completed
Chicago, 60637, United States
Completed
Tampa, 33609, United States
Completed
Berkeley, 94705, United States
Completed
Tampa, 33606, United States
Completed
San Francisco, 94117, United States
Completed
Rochester, 14642, United States
Completed
Mineola, 11501, United States
Completed
Nashville, 37205, United States
Completed
Durham, 27710, United States
Completed
Winston-Salem, 27157, United States
Completed
Henderson, 89052, United States
Completed
Charlotte, 28207, United States
Completed
Seattle, 98101, United States
Completed
Washington, 20037, United States
Completed
Louisville, 40202, United States
Completed
Kansas City, 66160, United States
Completed
Philadelphia, 19104, United States
Completed
Indianapolis, 46202, United States
Completed
San Antonio, 78229, United States
Completed
Cullman, 35058, United States
Completed
Shreveport, 71130, United States
Completed
Columbus, 43210, United States
Completed
Houston, 77030, United States
Completed
Providence, 02905, United States
Completed
Fairfax, 22031, United States
Completed
Miami, 33136, United States
Completed
Charleston, 29425, United States
Completed
Phoenix, 85013, United States
Completed
Halifax, B3H 2Y9, Canada
Completed
Pittsburgh, 15213, United States
Completed
Cincinnati, 45219, United States
Completed
La Jolla, 92037, United States
Completed
Newark, 19713, United States
Completed
Atlanta, 30309-1465, United States
Completed
Maitland, 32751, United States
Completed
Tacoma, 98405, United States
Completed
Fort Collins, 80528, United States
Completed
Hull, J8Y 1W7, Canada
Completed
Calgary, T2N 2T9, Canada
Completed
Vancouver, V6T 2B5, Canada
Completed
Nepean, K2G 6E2, Canada
Completed
Nimes, 30029, France
Completed
nancy, 54035, France
Completed
nice, 06000, France
Withdrawn
Montreal, H2L 4M1, Canada
Completed
Ottawa, K1H 8L6, Canada
Completed
Montreal, H3A 2B4, Canada
Completed
Toronto, M5B 1W8, Canada
Completed
London, N6A 5A5, Canada
Completed
Greenfield Park, J4V 2H1, Canada
Completed
Mississauga, L5B 1B8, Canada
Completed
Lille, 59037, France
Completed
Rennes, 35038, France
Completed
Dijon, 21033, France
Completed
Bordeaux, 33076, France
Completed
Nantes, 44093, France
Withdrawn
Clermont ferrand, 63003, France
Completed
L'Hospitalet de Llobregat, 08907, Spain
Completed
Malaga, 29010, Spain
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Terminated
Policlinico ConsorzialeBari, 70122, Italy
Withdrawn
Toulouse, 31059, France
Completed
Sevilla, 41071, Spain
Completed
Firenze, 50134, Italy
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
A.O. S.AndreaRoma, 00189, Italy
Completed
Athens, 11527, Greece
Completed
Uppsala, 751 85, Sweden
Completed
Tampere, 33521, Finland
Completed
MELSBROEK, 1820, Belgium
Completed
Dublin, 9, Ireland
Completed
Dublin, 4, Ireland
Completed
Cork, Ireland
Completed
Dublin, Ireland
Completed
Dresden, 01307, Germany
Completed
Marburg, 35039, Germany
Completed
Hamburg, 20246, Germany
Terminated
Ospedale San Luigi GonzagaOrbassano, 10043, Italy
Completed
Thessaloniki, 54636, Greece
Completed
Stockholm, 182 88, Sweden
Completed
Bergen, N-5021, Norway
Completed
Oulu, 90029, Finland
Completed
Brussel, 1090, Belgium
Completed
Nijmegen, 6533 PA, Netherlands
Completed
Sittard, 6131 BK, Netherlands
Completed
Breda, 4819 EV, Netherlands
Completed
Hannover, 30625, Germany
Completed
Greifswald, 17475, Germany
Completed
Hennigsdorf, 16761, Germany
Completed
Halle, 06120, Germany
Completed
Leipzig, 04129, Germany
Completed
Berlin, 13347, Germany
Completed
Hamburg, 20099, Germany
Completed
Heidelberg, 69120, Germany
Completed
Düsseldorf, 40225, Germany
Completed
Göttingen, 37099, Germany
Completed
Offenbach, 63069, Germany
Completed
Essen, 45117, Germany
Completed
Innsbruck, 6020, Austria
Completed
St. Gallen, 9007, Switzerland
Completed
Warszawa, 02957, Poland
Completed
Gdansk, 80-803, Poland
Completed
Katowice, 40752, Poland
Completed
Budapest, 1076, Hungary
Completed
Pecs, 7623, Hungary
Completed
Budapest, 1145, Hungary
Completed
Maribor, 2000, Slovenia
Completed
Moskva, 127018, Russia
Completed
Bayreuth, 95445, Germany
Completed
Gießen, 35392, Germany
Completed
Berlin, 13585, Germany
Completed
Münster, 48149, Germany
Completed
Regensburg, 93053, Germany
Completed
Hannover, 30559, Germany
Completed
Linz, 4020, Austria
Completed
St Poelten, A-3100, Austria
Completed
Bern, 3010, Switzerland
Completed
Wroclaw, 50420, Poland
Completed
Lodz, 90153, Poland
Completed
Warszawa, 02097, Poland
Completed
Poznan, 61848, Poland
Completed
Zalaegerszeg-Pozva, H-8900, Hungary
Completed
Györ, 9024, Hungary
Completed
Miskolc, 3501, Hungary
Completed
Ljubljana, SI-1525, Slovenia
Completed
Moskva, 118089, Russia
Completed
Nizhy Novgorod, 603076, Russia
Completed
Kiev, 03110, Ukraine
Completed
Riga, LV-1015, Latvia
Completed
Jerusalem, 91120, Israel
Completed
Tel Hashomer, 52621, Israel
Completed
Haifa, 31048, Israel
Completed
Ashkelon, 78278, Israel
Completed
Zerifin, 70300, Israel
Completed
Rosario, S2000ZBL, Argentina
Completed
Buenos Aires, C1117ABE, Argentina
Completed
Cordoba, X5000HGX, Argentina
Completed
Campinas, 13081- 970, Brazil
Completed
Sao Paulo, 01221-020, Brazil
Completed
Recife, 52010-040, Brazil
Completed
Kogarah, 2217, Australia
Completed
Moscow, 123367, Russia
Completed
Moskva, 117049, Russia
Completed
Sankt-Peterburg, 197022, Russia
Completed
St. Petersburg, 197376, Russia
Completed
Novosibirsk, 630007, Russia
Completed
Moskva, 129110, Russia
Completed
Yaroslavl, 150000, Russia
Completed
St. Petersburg, 194044, Russia
Completed
Donetsk, 83003, Ukraine
Completed
Kharkiv, 61068, Ukraine
Completed
Lviv, 79000, Ukraine
Completed
Sourasky Medical CenterTel-Aviv, 64239, Israel
Completed
Rosario, Argentina
Completed
Buenos Aires, C1416CRJ, Argentina
Completed
Buenos Aires, C1280AEB, Argentina
Completed
Sao Paulo, 04039-032, Brazil
Completed
Sao Paulo, 05403-900, Brazil
Completed
Curitiba, 80240-340, Brazil
Completed
Rio de Janeiro, 21941-590, Brazil
Completed
Porto Alegre, 90035-001, Brazil
Completed
Wyoming, NSW 2250, Australia
Completed
Fitzroy, 3065, Australia
Completed
Liverpool, NSW 2170, Australia
Withdrawn
Nedlands, 6009, Australia
Completed
Parkville, 3050, Australia

Primary Outcome

  • Flu-like-syndrome
    date_rangeTime Frame:
    309 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Injection-site Reactions
    date_rangeTime Frame:
    309 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Liver Enzyme Elevations
    date_rangeTime Frame:
    309 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Hematological Abnormalities
    date_rangeTime Frame:
    309 days
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off Values
    date_rangeTime Frame:
    309 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A): double-blind Betaseron/Betaferon 250µg or 500µg or open-label Betaseron/Betaferon 250µg and (Phase B): open-label Betaseron/Betaferon 500µg
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.