Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-04-24 @ 8:47 AM
Study NCT ID:
NCT02969304
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2016-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Utilization Patterns of Dimethyl Fumarate in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}], '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'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 930}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of dimethyl fumarate use that is prescribed "on-label" versus "off-label" in Germany', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics of dimethyl fumarate users', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}, {'measure': 'Prescription drug history of dimethyl fumarate users', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}, {'measure': 'Duration of therapy in participants newly initiating dimethyl fumarate treatment', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}, {'measure': 'Number of medical specialists prescribing dimethyl fumarate as identified according to specialty-specific billing codes at outpatient visits.', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}, {'measure': 'Medical history of dimethyl fumarate users', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}, {'measure': 'Concomitant medication use of dimethyl fumarate users', 'timeFrame': 'Up to 18 months after market introduction of dimethyl fumarate in Germany'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tecfidera', 'Off-label', 'Utilization'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to estimate the proportion of DMF use that is prescribed "on-label" versus "off-label". The secondary objectives are: To describe the demographic characteristics and medical history of DMF users; To describe prescription drug history and concomitant medication use of DMF users; To describe the duration of therapy in participants newly initiating DMF treatment; To describe the medical specialties of DMF prescribers.', 'detailedDescription': 'Dimethyl fumarate will not be provided to participants as a part of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective analysis of a research database, which contains German sick fund claims, to assess the usage of dimethyl fumarate in Germany. The research database is comprised of German sick fund data, which is compiled by Gesundheitsforen Leipzig (GFL). This GFL database currently contains sick fund claims data for approximately 4 million patients, which accounts for approximately 5-6% of the total sick fund population in Germany.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* New users of dimethyl fumarate will be included in the analysis\n\nKey Exclusion Criteria:\n\n* Patients for which data is not available for the 6 months period prior to the index date (baseline observational period)\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02969304', 'briefTitle': 'Study of Utilization Patterns of Dimethyl Fumarate in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Claims Database Study of Utilization Patterns of Dimethyl Fumarate in Germany', 'orgStudyIdInfo': {'id': '109MS409'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Off-Label', 'description': 'Any DMF prescription for MS patients \\<18 years of age, or for patients diagnosed with non-MS indications, such as psoriasis.', 'interventionNames': ['Drug: dimethyl fumarate']}, {'label': 'On-Label', 'description': 'Prescriptions for patients who are ≥18 years of age and diagnosed with MS', 'interventionNames': ['Drug: dimethyl fumarate']}], 'interventions': [{'name': 'dimethyl fumarate', 'type': 'DRUG', 'otherNames': ['Tecfidera, DMF, BG00012'], 'description': 'Off-Label Use: All participants \\<18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate\n\nOn-Label Use: All participants \\>18 years of age with an MS diagnosis who are prescribed dimethyl fumarate', 'armGroupLabels': ['Off-Label', 'On-Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04109', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}