Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-02-06 @ 8:13 PM
Study NCT ID:
NCT00534261
Status:
COMPLETED
Last Update Posted:
2007-12-13
First Post:
2007-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'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': 'D000068556', 'term': 'Interferon beta-1a'}], '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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2004-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-11', 'studyFirstSubmitDate': '2007-09-21', 'studyFirstSubmitQcDate': '2007-09-21', 'lastUpdatePostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®).', 'timeFrame': 'screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24'}], 'secondaryOutcomes': [{'measure': 'Reproducibility of Quality of Life scales per language version', 'timeFrame': 'months 18 and 24'}, {'measure': 'Reliability of the Quality of Life scales per language version', 'timeFrame': 'months 18 and 24'}, {'measure': 'EDSS score throughout the study', 'timeFrame': 'screening, Day -1, Months 12 and 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Avonex', 'Interferon beta-1a'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a', 'detailedDescription': "The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsing Remitting Multiple Sclerosis\n* Interferon naïve\n* Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics:\n* Subject has had relapsing MS for \\> 1 year\n* Subject has had experienced 2 exacerbations in the last 2 years\n* Subject had an EDSS \\[5\\] score of \\< 5.5\n* Subject was ambulant\n\nExclusion Criteria:\n\n* Diagnosis of MS defined as progressive\n* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta\n* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin\n* History of seizures within the 3 months prior to starting this study\n* History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study\n* History of intolerance to interferons\n* Previous use of interferon beta\n* Female subjects who were pregnant or breast-feeding\n* For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception'}, 'identificationModule': {'nctId': 'NCT00534261', 'acronym': 'FLAIR', 'briefTitle': 'Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)', 'orgStudyIdInfo': {'id': 'BIO-BNL 99-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patients received Avonex IM injections and be evaluated for quality of life criteria', 'interventionNames': ['Drug: Interferon beta-1a']}], 'interventions': [{'name': 'Interferon beta-1a', 'type': 'DRUG', 'description': 'IM injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8340', 'city': 'Sijsele-Damme', 'country': 'Belgium', 'facility': 'Coordinating Research Site'}, {'zip': '4011', 'city': 'Esch-sur-Alzette', 'country': 'Luxembourg', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 49.49583, 'lon': 5.98056}}, {'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Biogen-Idec Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'neurologyclinicaltrials@biogenidec.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}}}}