Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-25 @ 2:19 PM
Study NCT ID:
NCT00168766
Status:
COMPLETED
Last Update Posted:
2013-09-16
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
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': '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Combination therapy for multiple sclerosis'], 'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '20542736', 'type': 'DERIVED', 'citation': 'Ravnborg M, Sorensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholome E, Constantinescu CS, Beer K, Garde E, Sperling B. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):672-80. doi: 10.1016/S1474-4422(10)70132-0. Epub 2010 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.', 'detailedDescription': 'Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy\n* Disability EDSS score of 4.0 or less at baseline\n* Clinical activity as defined by at least one relapse in the last year\n\nExclusion Criteria:\n\n* Relapse in the month prior to enrolment\n* Treatment with immunosuppressive drugs for MS\n* History of major depression\n* Former severe reactions to corticosteroids\n* Pregnant women\n* Diabetes mellitus, and drug or alcohol dependency\n* Known or suspected allergy to trial products'}, 'identificationModule': {'nctId': 'NCT00168766', 'briefTitle': 'Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS', 'nctIdAliases': ['NCT00492180'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'NOR-03-01'}, 'secondaryIdInfos': [{'id': 'Mecombin'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'interferon-beta-1a in combination with methylprednisolone', 'interventionNames': ['Drug: Interferon-beta-1a (Avonex) plus methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'interferon-beta-1a in combination with placebo', 'interventionNames': ['Drug: Interferon-beta-1a (Avonex) plus methylprednisolone']}], 'interventions': [{'name': 'Interferon-beta-1a (Avonex) plus methylprednisolone', 'type': 'DRUG', 'otherNames': ['Avonex'], 'description': 'oral administration given on 3 consecutive days, monthly as described in protocol.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'CUB Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Coordinating Research Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Skleroseklinikken', 'country': 'Denmark', 'facility': 'Rigshospitalet'}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampereen yliopistollinen sairaala - Neurologian klinikka', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Nijemegen', 'country': 'Netherlands', 'facility': 'Stichting MS Centrum'}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Ullevål Universitetssykehus', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Neurologkliniken', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonspital', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'Ng72uh', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queens Medical Centre - Division of Neurology', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Biogen Idec MD, Nordic Medical Director', 'oldOrganization': 'Biogen Idec International'}}}}