Trial Condition(s):
Multiple Sclerosis, Relapsing-Remitting
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose (Beyond)
Bayer Identifier:
91656
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations Investigative Site Graz, Austria, 8036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tualatin, United States, 97062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Birmingham, United States, 35294-7340 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Reno, United States, 89509 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Duluth, United States, 55805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newark, United States, 07103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tucson, United States, 85741 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stony Brook, United States, 11794 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albuquerque, United States, 87131-5281 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Wayne, United States, 46805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Des Moines, United States, 50314 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chicago, United States, 60637 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampa, United States, 33609 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berkeley, United States, 94705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampa, United States, 33606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Francisco, United States, 94117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rochester, United States, 14642 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mineola, United States, 11501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nashville, United States, 37205 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Winston-Salem, United States, 27157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Henderson, United States, 89052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charlotte, United States, 28207 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seattle, United States, 98101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Washington, United States, 20037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Louisville, United States, 40202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kansas City, United States, 66160 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Philadelphia, United States, 19104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Indianapolis, United States, 46202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cullman, United States, 35058 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shreveport, United States, 71130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Columbus, United States, 43210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Providence, United States, 02905 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fairfax, United States, 22031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Charleston, United States, 29425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Phoenix, United States, 85013 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halifax, Canada, B3H 2Y9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15213 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cincinnati, United States, 45219 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site La Jolla, United States, 92037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Newark, United States, 19713 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Atlanta, United States, 30309-1465 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maitland, United States, 32751 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tacoma, United States, 98405 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Collins, United States, 80528 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hull, Canada, J8Y 1W7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calgary, Canada, T2N 2T9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vancouver, Canada, V6T 2B5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nepean, Canada, K2G 6E2 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nimes, France, 30029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site nancy, France, 54035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site nice, France, 06000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H3A 2B4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 5A5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greenfield Park, Canada, J4V 2H1 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mississauga, Canada, L5B 1B8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rennes, France, 35038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dijon, France, 21033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bordeaux, France, 33076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nantes, France, 44093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Malaga, Spain, 29010 | 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 Policlinico Consorziale Bari, Italy, 70122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Firenze, Italy, 50134 | 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 A.O. S.Andrea Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MELSBROEK, Belgium, 1820 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, 9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland, 4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cork, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dublin, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Luigi Gonzaga Orbassano, Italy, 10043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Thessaloniki, Greece, 54636 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stockholm, Sweden, 182 88 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bergen, Norway, N-5021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Brussel, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nijmegen, Netherlands, 6533 PA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sittard, Netherlands, 6131 BK | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Breda, Netherlands, 4819 EV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Greifswald, Germany, 17475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hennigsdorf, Germany, 16761 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Halle, Germany, 06120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13347 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Heidelberg, Germany, 69120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Düsseldorf, Germany, 40225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göttingen, Germany, 37099 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Offenbach, Germany, 63069 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Essen, Germany, 45117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Gallen, Switzerland, 9007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02957 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gdansk, Poland, 80-803 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Katowice, Poland, 40752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pecs, Hungary, 7623 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Budapest, Hungary, 1145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maribor, Slovenia, 2000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moskva, Russia, 127018 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bayreuth, Germany, 95445 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gießen, Germany, 35392 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 13585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Münster, Germany, 48149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Regensburg, Germany, 93053 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hannover, Germany, 30559 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Linz, Austria, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St Poelten, Austria, A-3100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wroclaw, Poland, 50420 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodz, Poland, 90153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Poznan, Poland, 61848 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zalaegerszeg-Pozva, Hungary, H-8900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Györ, Hungary, 9024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Miskolc, Hungary, 3501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ljubljana, Slovenia, SI-1525 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moskva, Russia, 118089 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nizhy Novgorod, Russia, 603076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine, 03110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Riga, Latvia, LV-1015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 91120 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tel Hashomer, Israel, 52621 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 31048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ashkelon, Israel, 78278 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zerifin, Israel, 70300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, S2000ZBL | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1117ABE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cordoba, Argentina, X5000HGX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Campinas, Brazil, 13081- 970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 01221-020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Recife, Brazil, 52010-040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kogarah, Australia, 2217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moscow, Russia, 123367 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moskva, Russia, 117049 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sankt-Peterburg, Russia, 197022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 197376 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novosibirsk, Russia, 630007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Moskva, Russia, 129110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yaroslavl, Russia, 150000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 194044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Donetsk, Ukraine, 83003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kharkiv, Ukraine, 61068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lviv, Ukraine, 79000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sourasky Medical Center Tel-Aviv, Israel, 64239 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1416CRJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1280AEB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 04039-032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sao Paulo, Brazil, 05403-900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Curitiba, Brazil, 80240-340 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rio de Janeiro, Brazil, 21941-590 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Porto Alegre, Brazil, 90035-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wyoming, Australia, NSW 2250 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fitzroy, Australia, 3065 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Liverpool, Australia, NSW 2170 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Parkville, Australia, 3050 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Flu-like-syndromeTimeframe: 309 days
- Injection-site ReactionsTimeframe: 309 days
- Liver Enzyme ElevationsTimeframe: 309 days
- Hematological AbnormalitiesTimeframe: 309 days
Secondary Outcome
- Percentage of Patients With Neutralizing Antibody Titer to IFNB-1b of Different Cut-off ValuesTimeframe: 309 days
Additional Information
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