Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-28 @ 8:26 PM
Study NCT ID:
NCT00963833
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2009-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Portugal']}, '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': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-10', 'studyFirstSubmitDate': '2009-08-21', 'studyFirstSubmitQcDate': '2009-08-21', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of Betaferon in this patient population', 'timeFrame': 'Up 24 months'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients being relapse free', 'timeFrame': 'Up to 24 months'}, {'measure': 'Time to first relapse', 'timeFrame': 'Up to 24 months'}, {'measure': 'Annualized relapse rate', 'timeFrame': 'Up to 24 months'}, {'measure': 'Disability progression measured by the expanded disability status scale (EDSS)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Outcome on neurological function', 'timeFrame': 'Up to 24 months', 'description': 'e.g. IQ assessment using Standard Progressive Matrices (SPM) and Wechsler intelligence scale for children-fourth edition (WISCIV®), assessment of visual and motor integration using Beery VMI , and assessment of attention and concentration using d2 test.'}, {'measure': 'Fatigue assessed by Fatigue Severity Scale (FSS)', 'timeFrame': 'Up to 24 months'}, {'measure': 'MRI measurements (if available)', 'timeFrame': 'Up to 24 months', 'description': 'e.g. number of new T2 lesions, number of new contrast enhancing lesions'}, {'measure': 'MRI measurements and potential correlation with neuropsychological impairment', 'timeFrame': 'Up to 24 months'}, {'measure': 'Laboratory outcomes', 'timeFrame': 'Up to 24 months', 'description': 'Laboratory examinations: hemoglobin, mean corpuscular volume, platelets, leukocytes, ALAT/GPT, ASAT/GOT, Alkaline phosphatase, and Gamma-GT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'MS', 'Non-interventional'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years.\n\nThe aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions.\n\nAs this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment naive children and adolescents aged 12 to 16 years at inclusion diagnosed with RRMS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment naive children and adolescents of 12 to 16 years of age at inclusion with a diagnosis of RRMS according to revised McDonald or Poser criteria and decision taken by the investigator to treat with Betaferon. The local Betaferon product information must be considered.\n\nExclusion Criteria:\n\n* Contraindications stated in the local Betaferon product information; warnings and precautions must be considered.'}, 'identificationModule': {'nctId': 'NCT00963833', 'briefTitle': 'Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '14438'}, 'secondaryIdInfos': [{'id': 'BF0802', 'type': 'OTHER', 'domain': 'NIS Trial Alias'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Interferon beta-1b (Betaseron, BAY86-5046)']}], 'interventions': [{'name': 'Interferon beta-1b (Betaseron, BAY86-5046)', 'type': 'DRUG', 'description': 'Patients under daily life treatment receiving Betaferon according to local product information.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Austria'}, {'city': 'Many Locations', 'country': 'Belgium'}, {'city': 'Many Locations', 'country': 'Finland'}, {'city': 'Many Locations', 'country': 'Germany'}, {'city': 'Many Locations', 'country': 'Israel'}, {'city': 'Many Locations', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}