Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT01076595
Status:
COMPLETED
Last Update Posted:
2015-07-03
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D012008', 'term': 'Recurrence'}], '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': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-02', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The adherence to treatment (rate of patients continuing with Betaferon® regimen after 24 months)', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Compliance to Betaferon according physician (rate of patients with compliance rater > 94,5%)', 'timeFrame': '6 months, 12 months, 24 months'}, {'measure': 'Adherence to treatment (rate of patients continuing with the Betaferon® regimen at 6 and 12 months)', 'timeFrame': '6 months, 12 months'}, {'measure': 'Rate of patients with prematurely study discontinuation', 'timeFrame': '0-6 months, 6-12 months, 12-18 months, 18-24 months'}, {'measure': "Patient's autonomy with regard to the Betaferon® injections (Number of injections realized by the patient alone/total number of injections)", 'timeFrame': '24 months'}, {'measure': 'Tolerability of Betaferon injections (rate and number of injections)', 'timeFrame': '24 months'}, {'measure': "Patient's Quality of Life (Mean total score of FAMS [Functional Assessment of Multiple Sclerosis])", 'timeFrame': '24 months'}, {'measure': 'Fatigue (mean total score of FSS [Fatigue Severity scale])', 'timeFrame': '24 months'}, {'measure': 'Progression of clinical Condition( annual rate of Relapses)', 'timeFrame': '24 months'}, {'measure': 'Percentage of patients with change of in EDSS (Expanded Disability Status Scale) < 1 between M0 and end of the study', 'timeFrame': '24 months'}, {'measure': 'Percentage of patients with change in EDSS< 1 and no relapse between M0 and M24', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'BetaPlus program', 'Recurrent/remittent multiple sclerosis patients', 'Adherence to treatment regimen'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The aim of the SEPLUS study is to evaluate the patients characteristics associated with adherence to Betaferon over a 24-month follow up period after the initiation of Betaferon in the BetaPlus program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\>/= 18 years old\n* Outpatient with a confirmed diagnosis of Recurrent-Remittent multiple sclerosis or patients at high risk of developing multiple sclerosis after a first demyelinating clinical event\n* Patient who initiated Betaferon as described by SmPC less than 2 months ago. The decision of physician is clearly separated from the decision to include the patient in the study\n* Treatment naïve patients before the initiation of Betaferon\n* OR Patients having interrupted Betaferon for more than 6 months before to start again\n* OR Patients receiving a disease modifying drug (DMD) other than Betaferon\n* Patient with EDSS score \\< 4\n* Patients approved and signed an inform consent and approved the collect of their data\n\nExclusion Criteria:\n\n* Contraindications and warning of the respective Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT01076595', 'acronym': 'SEPLUS', 'briefTitle': 'Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': "Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program", 'orgStudyIdInfo': {'id': '15098'}, 'secondaryIdInfos': [{'id': 'BF0910FR', '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': 'Betaferon 250 microgram', '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'}}}}