Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT00787657
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2008-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
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'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1723}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-15', 'studyFirstSubmitDate': '2008-11-06', 'studyFirstSubmitQcDate': '2008-11-06', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients adhering to treatment', 'timeFrame': '6, 12, 18 and 24 months'}], 'secondaryOutcomes': [{'measure': 'Rate of early treatment termination', 'timeFrame': '6, 12, 18 and 24 months'}, {'measure': 'Rate of study dropout', 'timeFrame': '6, 12, 18 and 24 months'}, {'measure': 'Predictive value of BL parameters, WCQ, HADS, RODQ', 'timeFrame': '12 and 24 months'}, {'measure': 'WCQ (Ways of Coping Questionnaire)', 'timeFrame': '6, 12, 18 and 24 months'}, {'measure': 'HADS (Hospital Anxiety and Depression Scale)', 'timeFrame': '6, 12, 18 and 24 months'}, {'measure': 'RODQ (Risk of Dropout Questionnaire)', 'timeFrame': 'Monthly over 6 months; every other month thereafter'}, {'measure': 'EDSS (Expanded Disability Status Scale)', 'timeFrame': '6, 12, 18 and 24 months'}, {'measure': 'Relapse rate', 'timeFrame': '6, 12, 18 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clinically Isolated Syndrome (CIS)'], 'conditions': ['Relapsing Remitting Multiple Sclerosis (RRMS)']}, 'referencesModule': {'references': [{'pmid': '34425763', 'type': 'DERIVED', 'citation': 'Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.'}]}, 'descriptionModule': {'briefSummary': '* The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.\n* The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.\n\nExclusion Criteria:\n\n* Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)'}, 'identificationModule': {'nctId': 'NCT00787657', 'acronym': 'BEACON', 'briefTitle': 'Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Betaferon Prospective Study on Adherence, Coping and Nursing Support', 'orgStudyIdInfo': {'id': '13852'}, 'secondaryIdInfos': [{'id': '311941', 'type': 'OTHER', 'domain': 'company internal'}, {'id': 'BF0703', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}], 'interventions': [{'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Argentina'}, {'city': 'Many Locations', 'country': 'Bahrain'}, {'city': 'Many Locations', 'country': 'Belgium'}, {'city': 'Many Locations', 'country': 'Bosnia and Herzegovina'}, {'city': 'Many Locations', 'country': 'Canada'}, {'city': 'Many Locations', 'country': 'China'}, {'city': 'Many Locations', 'country': 'Colombia'}, {'city': 'Many Locations', 'country': 'Czechia'}, {'city': 'Many Locations', 'country': 'Egypt'}, {'city': 'Many Locations', 'country': 'Estonia'}, {'city': 'Many Locations', 'country': 'France'}, {'city': 'Many Locations', 'country': 'Germany'}, {'city': 'Many Locations', 'country': 'Iran'}, {'city': 'Many Locations', 'country': 'Israel'}, {'city': 'Many Locations', 'country': 'Italy'}, {'city': 'Many Locations', 'country': 'Jordan'}, {'city': 'Many Locations', 'country': 'Kuwait'}, {'city': 'Many Locations', 'country': 'Lebanon'}, {'city': 'Many Locations', 'country': 'Libya'}, {'city': 'Many Locations', 'country': 'Mexico'}, {'city': 'Many Locations', 'country': 'Netherlands'}, {'city': 'Many Locations', 'country': 'New Zealand'}, {'city': 'Many Locations', 'country': 'Norway'}, {'city': 'Many Locations', 'country': 'Pakistan'}, {'city': 'Many Locations', 'country': 'Portugal'}, {'city': 'Many Locations', 'country': 'Saudi Arabia'}, {'city': 'Many Locations', 'country': 'Singapore'}, {'city': 'Many Locations', 'country': 'Slovakia'}, {'city': 'Many Locations', 'country': 'Slovenia'}, {'city': 'Many Locations', 'country': 'South Korea'}, {'city': 'Many Locations', 'country': 'Sweden'}, {'city': 'Many Locations', 'country': 'Syria'}, {'city': 'Many Locations', 'country': 'Taiwan'}, {'city': 'Many Locations', 'country': 'United Arab Emirates'}, {'city': 'Many Locations', 'country': 'United Kingdom'}, {'city': 'Many Locations', 'country': 'Venezuela'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}