Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT00928967
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2009-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2009-06-23', 'studyFirstSubmitQcDate': '2009-06-25', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evolution of the Daily Life score: Analysis of variance for repeated measurements.', 'timeFrame': 'After 1, 3, 6, 9 and 12 months'}], 'secondaryOutcomes': [{'measure': "Evolution of the SF 36 score, Fatigue score, Beck's depression score: analysis of variance for repeated measurements", 'timeFrame': 'Over 12 months'}, {'measure': 'Correlation coefficient with quality of life scales', 'timeFrame': 'Over 12 months'}, {'measure': 'Kinetics of treatment discontinuation: Kaplan Meier', 'timeFrame': 'Over 12 months'}, {'measure': 'Rate of treatment continuation', 'timeFrame': 'After 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Quality of life'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria.The choice of treatment must be clearly dissociated from the decision to include the patient in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females aged 18 years or over, having received a confirmed diagnosis of RRMS as defined by the MacDonald or Poser criteria or after a first clinical demyelinating event suggestive of Multiple Sclerosis, and meeting the requirements of the study inclusion criteria\n* The choice of treatment must be clearly dissociated from the decision to include the patient in the study.'}, 'identificationModule': {'nctId': 'NCT00928967', 'briefTitle': 'Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS', 'orgStudyIdInfo': {'id': '14168'}, 'secondaryIdInfos': [{'id': 'Daily Life Study', 'type': 'OTHER', 'domain': 'company internal'}, {'id': 'BF0610FR', 'type': 'OTHER', 'domain': 'company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Interferon beta-1b, (Betaseron BAY86-5046)']}], 'interventions': [{'name': 'Interferon beta-1b, (Betaseron BAY86-5046)', 'type': 'DRUG', 'description': 'The cohort included is described in section 8.5 (inclusion criteria)', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'France'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}