Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 6:17 AM
Study NCT ID:
NCT01838668
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2013-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'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': 'D000069462', 'term': 'Dimethyl Fumarate'}], 'ancestors': [{'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-19', 'studyFirstSubmitDate': '2013-04-20', 'studyFirstSubmitQcDate': '2013-04-20', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24.', 'timeFrame': 'Part I (Week 24)'}, {'measure': 'Incidence of treatment-emergent adverse events and serious adverse events', 'timeFrame': 'Part II (Up to 4.5 years)'}], 'secondaryOutcomes': [{'measure': 'Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24', 'timeFrame': 'Part I (Week 24)'}, {'measure': 'Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline', 'timeFrame': 'Part I (Week 24)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Relapsing-Remitting Multiple Sclerosis', 'Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '31391949', 'type': 'DERIVED', 'citation': 'Kondo T, Kawachi I, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. Efficacy of dimethyl fumarate in Japanese multiple sclerosis patients: interim analysis of randomized, double-blind APEX study and its open-label extension. Mult Scler J Exp Transl Clin. 2019 Jul 31;5(3):2055217319864974. doi: 10.1177/2055217319864974. eCollection 2019 Jul-Sep.'}, {'pmid': '30616596', 'type': 'DERIVED', 'citation': 'Saida T, Yamamura T, Kondo T, Yun J, Yang M, Li J, Mahadavan L, Zhu B, Sheikh SI. A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries. BMC Neurol. 2019 Jan 7;19(1):5. doi: 10.1186/s12883-018-1220-3.'}, {'pmid': '30206820', 'type': 'DERIVED', 'citation': 'Ochi H, Niino M, Onizuka Y, Hiramatsu K, Hase M, Yun J, Matta A, Torii S. 72-Week Safety and Tolerability of Dimethyl Fumarate in Japanese Patients with Relapsing-remitting Multiple Sclerosis: Analysis of the Randomised, Double Blind, Placebo-Controlled, Phase III APEX Study and its Open-Label Extension. Adv Ther. 2018 Oct;35(10):1598-1611. doi: 10.1007/s12325-018-0788-8. Epub 2018 Sep 11.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-004533-32/results', 'label': 'EudraCT Tabulated Result'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter study conducted in 2 parts:\n\nThe primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region.\n\nThe secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline.\n\nThe primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Inclusion Criteria for Part I:\n\n * Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).\n * Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.\n\nKey Inclusion Criteria for Part II:\n\n• Subjects who participated in and completed Part I per protocol.\n\nKey Exclusion Criteria:\n\n* Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.\n* Pregnant or nursing women.\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01838668', 'briefTitle': 'An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': '109MS305'}, 'secondaryIdInfos': [{'id': '2013-004533-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Part I Placebo', 'description': 'Placebo orally twice a day. In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID\n\nParticipants will begin the study by taking 1 capsule orally BID for first 7 days and escalate their dosing from day 8 to 2 matching capsules orally BID.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part I BG00012', 'description': 'BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg BG00012 twice daily (BID) for the first 7 days and 240 mg BG00012 BID thereafter.) In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID', 'interventionNames': ['Drug: dimethyl fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Part II BG00012', 'description': 'Part II: All participants will receive BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg (1 capsule) BG00012 twice daily (BID) for the first 7 days and 240 mg (2 capsules) BG00012 BID thereafter.', 'interventionNames': ['Drug: dimethyl fumarate']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Two placebo capsules orally BID', 'armGroupLabels': ['Part I Placebo']}, {'name': 'dimethyl fumarate', 'type': 'DRUG', 'otherNames': ['BG00012', 'Tecfidera', 'DMF'], 'description': 'Two dimethyl fumarate 120mg capsules orally BID', 'armGroupLabels': ['Part I BG00012', 'Part II BG00012']}]}, 'contactsLocationsModule': {'locations': [{'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice u sv. 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