Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-26 @ 7:50 PM
Study NCT ID:
NCT03408093
Status:
COMPLETED
Last Update Posted:
2018-06-21
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000068576', 'term': 'Interferon beta-1b'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2010-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-20', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported adherence to INFb-1b in the previous four weeks assessed by Morisky-Green (MG) test', 'timeFrame': 'Four weeks just before baseline visit'}], 'secondaryOutcomes': [{'measure': 'Demographic data', 'timeFrame': 'At baseline', 'description': 'Age, sex, marital status, education level, employment status'}, {'measure': 'Number of patients with MS diagnosis', 'timeFrame': 'At baseline'}, {'measure': 'Age at first episode and at diagnosis', 'timeFrame': 'At baseline'}, {'measure': 'Time since last relapse', 'timeFrame': 'At baseline'}, {'measure': 'Assessment of general health status using data from a questionnaire or from their clinical history collected by the investigator team', 'timeFrame': 'At baseline'}, {'measure': 'Expanded Disability Status Scale (EDSS) to assess the degree of disability caused by MS', 'timeFrame': 'At baseline', 'description': 'The EDSS quantifies the disability in eight functional systems (FS) and allows neurologists to assign a level of Functional System in each of them caused by multiple sclerosis.'}, {'measure': 'Number of patients with adverse events during the last month', 'timeFrame': 'Four weeks just before baseline visit'}, {'measure': 'Clinical setting characteristics like existence of MS unit', 'timeFrame': 'At baseline', 'description': 'The existence of Multiple Sclerosis Unit was evaluated bearing in mind if the hospital had or had not available a Multiple Sclerosis Unit into the hospital Neurology Department.'}, {'measure': 'Time on INFb-1b therapy', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interferon beta-1b (INFb-1b)', 'Multiple Sclerosis (MS)', 'Relapsing-remitting MS (RRMS)', 'Secondary progressive MS (SPMS)', 'Clinically isolated syndrome (CIS)'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '22615737', 'type': 'RESULT', 'citation': 'Fernandez O, Aguera E, Izquierdo G, Millan-Pascual J, Ramio I Torrenta L, Oliva P, Argente J, Berdei Y, Soler JM, Carmona O, Errea JM, Farres J; Group on Adherence to IFNb-1b in Spain. Adherence to interferon beta-1b treatment in patients with multiple sclerosis in Spain. PLoS One. 2012;7(5):e35600. doi: 10.1371/journal.pone.0035600. Epub 2012 May 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the adherence to the treatment with interferon beta-1b, in patients diagnosed with isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), or secondary progressive multiple sclerosis (SPMS) who had more than 6 months in treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included patients who had been on interferon beta-1b for more than 6 months and who agreed to participate in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with relapsing-remitting MS (RRMS), secondary progressive MS (SPMS) or patients with a first outbreak or clinically isolated syndrome (CIS) that carry more than 6 months in treatment with interferon beta-1b\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03408093', 'acronym': 'ADHERENCE', 'briefTitle': 'Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b', 'orgStudyIdInfo': {'id': '2008/01880'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Interferon beta-1b', 'description': 'Patients with CIS, RRMS or SPMS who had more than 6 months in treatment', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}], 'interventions': [{'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.', 'armGroupLabels': ['Interferon beta-1b']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}