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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00099502 |
The purpose of this study is to determine
Condition | Intervention | Phase |
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Multiple Sclerosis, Relapsing-Remitting |
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) Drug: Copaxone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily. |
Enrollment: | 2244 |
Study Start Date: | November 2003 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
250mcg administered s.c. every other day
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Arm 2: Experimental |
Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)
500mcg administered s.c. every other day
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Arm 3: Active Comparator |
Drug: Copaxone
20 mg administered s.c. once daily.
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This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer HealthCare Pharmaceuticals, Inc. ( Therapeutic Area Head ) |
Study ID Numbers: | 91162, EudraCT: 2005-002235-27, 306440, Beyond |
Study First Received: | December 15, 2004 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00099502 |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Canada: Health Canada; Sweden: Medical Products Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Brazil: Ministry of Health; Canada: Health Canada; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: Ministry of Health and Welfare; Ireland: Irish Medicines Board; Italy: Ministry of Health; Latvia: State Agency of Medicines; Netherlands: Dutch Health Care Inspectorate; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Slovenia: Ministry of Health; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; Ukraine: Ministry of Health; United States: Food and Drug Administration |
Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron |
Interferon Type I, Recombinant Autoimmune Diseases Demyelinating Diseases Interferons Interferon-beta Sclerosis Demyelinating diseases |
Multiple Sclerosis, Relapsing-Remitting Copolymer 1 Multiple Sclerosis Interferon beta-1b Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Anti-Infective Agents Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Adjuvants, Immunologic |
Immunosuppressive Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Pathologic Processes Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |