Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-27 @ 1:12 PM
Study NCT ID:
NCT00292266
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2006-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 677}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-02', 'studyFirstSubmitDate': '2006-02-13', 'studyFirstSubmitQcDate': '2006-02-13', 'lastUpdatePostDateStruct': {'date': '2013-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of exacerbation-free subjects', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of exacerbation-free subjects', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of exacerbation-free subjects', 'timeFrame': 'Week 72'}], 'secondaryOutcomes': [{'measure': 'Mean number of combined unique (CU) active lesions per subject per scan', 'timeFrame': 'Week 24'}, {'measure': 'Total exacerbation count per subject', 'timeFrame': 'Week 24, 48 and 72'}, {'measure': 'Mean Number of Time constant 2 (T2) active lesions per subject per scan', 'timeFrame': 'Week 24, 48 and 72'}]}, 'conditionsModule': {'keywords': ['Relapsing-remitting Multiple Sclerosis', 'Rebif®', 'Avonex®', 'interferon-beta-1a'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mslifelines.com', 'label': 'Full FDA approved prescribing information can be found here'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif® 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex® 30 mcg intramuscular injection given once a week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 55 years\n* Clinically definite or laboratory-supported definite relapsing-remitting MS according to Poser's criteria\n* Two or more relapses within the preceding 24 months\n* Clinical stability or improving neurological state during the 4 weeks before Study Day 1\n* Expanded disability status scale (EDSS) score from 0 to 5.5, inclusive\n* Two or more lesions consistent with MS on a Screening proton density/T2-magnetic resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI\n* Willingness and ability to comply with the protocol for the duration of the study\n* Written informed consent given before any study-related procedure not part of the subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care\n* For female subjects, lack of childbearing potential must be satisfied by either being post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized)\n\nExclusion Criteria:\n\n* Secondary progressive MS, primary progressive MS or progressive relapsing MS\n* Prior use of interferon\n* Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks of Study Day 1 or within 7 days before the Screening MRI\n* Psychiatric disorder that is unstable or will preclude safe participation in the study\n* Significant leucopenia (white blood cell count less than 0.5 times the lower limit of normal) within 7 days of Study Day 1\n* Elevated liver function tests (Alanine transaminase \\[ALT\\], Aspartate transaminase \\[AST\\], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1\n* Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months before Study Day 1\n* Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day 1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone\n* Previous use of cladribine or total lymphoid irradiation\n* Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic acid (DTPA)\n* Intravenous immunoglobulin or any other investigational drug or procedure in the 6 months before Study Day 1\n* Systemic disease that can interfere with subject safety, compliance or evaluation of the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)"}, 'identificationModule': {'nctId': 'NCT00292266', 'briefTitle': 'A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': '21125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebif®', 'interventionNames': ['Drug: Rebif®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avonex®', 'interventionNames': ['Drug: Avonex®']}], 'interventions': [{'name': 'Rebif®', 'type': 'DRUG', 'description': 'Rebif® injection will be administered subcutaneously at a dose of 44 mcg, three times per week, up to 72 weeks.', 'armGroupLabels': ['Rebif®']}, {'name': 'Avonex®', 'type': 'DRUG', 'description': 'Avonex® injection will be administered intramuscularly at a dose of 30 mcg, once weekly, up to 72 weeks.', 'armGroupLabels': ['Avonex®']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gordon Francis, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Serono International SA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Serono International SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}