Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT00099502
Status:
COMPLETED
Last Update Posted:
2008-12-19
First Post:
2004-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068576', 'term': 'Interferon beta-1b'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-18', 'studyFirstSubmitDate': '2004-12-15', 'studyFirstSubmitQcDate': '2004-12-15', 'lastUpdatePostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hazard ratio for relapses', 'timeFrame': 'During the first and during the second 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Time to confirmed Expanded Disability Status Score (EDSS) progression', 'timeFrame': 'After 52 and after 104 weeks'}, {'measure': 'Magnetic Resonance Imaging (MRI): Change from screening in volume of hypointense lesion on enhanced T1 weighted images', 'timeFrame': 'After 104 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Relapsing multiple sclerosis', 'interferon beta 1b', 'Betaferon', 'Betaseron'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '19729344', 'type': 'DERIVED', 'citation': "O'Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F, Filippov V, Groth M, Knappertz V, Kraus C, Sandbrink R, Pohl C, Bogumil T; BEYOND Study Group; O'Connor P, Filippi M, Arnason B, Cook S, Goodin D, Hartung HP, Kappos L, Jeffery D, Comi G. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Oct;8(10):889-97. doi: 10.1016/S1474-4422(09)70226-1. Epub 2009 Sep 2."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine\n\n* whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms\n* whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg', 'detailedDescription': '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.\n\nBayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients\n* Aged 18-55 years\n* Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis), EDSS score of 0 to 5.0\n* Treatment-naive to IFNB or Copaxone\n\nExclusion Criteria:\n\n* Neurological progression at disease onset or between relapses\n* Serious or acute heart diseases\n* History of severe depression or suicide attempt\n* Serious or acute liver, renal or bone marrow dysfunction\n* Monoclonal gammopathy\n* Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00099502', 'briefTitle': 'BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients', 'nctIdAliases': ['NCT00185432'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '91162'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2005-002235-27'}, {'id': '306440'}, {'id': 'Beyond'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'interventionNames': ['Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'interventionNames': ['Drug: Copaxone']}], 'interventions': [{'name': 'Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': '250mcg administered s.c. every other day', 'armGroupLabels': ['Arm 1']}, {'name': 'Interferon beta-1b (Betaferon/Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': '500mcg administered s.c. every other day', 'armGroupLabels': ['Arm 2']}, {'name': 'Copaxone', 'type': 'DRUG', 'description': '20 mg administered s.c. once daily.', 'armGroupLabels': 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