Viewing Study NCT01058005

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Ignite Creation Date: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2026-02-27 @ 3:43 PM
Study NCT ID: NCT01058005
Status: TERMINATED
Last Update Posted: 2014-09-03
First Post: 2010-01-26
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, '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': 'D000069442', 'term': 'Natalizumab'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogenidec.com', 'title': 'Biogen Idec Study Medical Director', 'organization': 'Biogen Idec'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to early termination of the study and the small size of the study population, there was insufficient power for efficacy and safety analyses. Only serious adverse events were to be captured and reported under the protocol.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Natalizumab', 'description': '300 mg intravenous injection every 4 weeks', 'otherNumAtRisk': 36, 'otherNumAffected': 19, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Interferon Beta-1a', 'description': '44 mcg subcutaneous injection 3 times per week', 'otherNumAtRisk': 22, 'otherNumAffected': 12, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Glatiramer Acetate', 'description': '20 mg subcutaneous injection once daily', 'otherNumAtRisk': 17, 'otherNumAffected': 11, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anaemia Macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fluid Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitamin B12 Deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Loss Of Proprioception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Memory Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Periodontal Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subcutaneous Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscle Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Micturition Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gait Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart Rate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitamin D Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Exposure To Toxic Agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Meningitis Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebral Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': '300 mg intravenous injection every 4 weeks'}, {'id': 'OG001', 'title': 'Interferon Beta-1a', 'description': '44 mcg subcutaneous injection 3 times per week'}, {'id': 'OG002', 'title': 'Glatiramer Acetate', 'description': '20 mg subcutaneous injection once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 108 Weeks', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Natalizumab', 'description': '300 mg intravenous injection every 4 weeks'}, {'id': 'FG001', 'title': 'Interferon Beta-1a', 'description': '44 mcg subcutaneous injection 3 times per week'}, {'id': 'FG002', 'title': 'Glatiramer Acetate', 'description': '20 mg subcutaneous injection once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Dosed With Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Withdrawn Due to Study Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Reason Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Natalizumab', 'description': '300 mg intravenous injection every 4 weeks'}, {'id': 'BG001', 'title': 'Interferon Beta-1a', 'description': '44 mcg subcutaneous injection 3 times per week'}, {'id': 'BG002', 'title': 'Glatiramer Acetate', 'description': '20 mg subcutaneous injection once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '9.51', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '37.6', 'spread': '13.16', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '10.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'whyStopped': 'Due to significantly slower than expected enrollment, the Sponsor decided to terminate the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2010-01-26', 'resultsFirstSubmitDate': '2014-07-23', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-23', 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Serious Adverse Events (SAEs)', 'timeFrame': 'up to 108 Weeks', 'description': 'An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.'}]}, 'conditionsModule': {'keywords': ['MS'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This was a multicenter, randomized, open-label, parallel-group, active-controlled study. Prior to randomization, participants were to have been treated with glatiramer acetate or interferon β-1a (44 μg). Participants were to be randomized to receive natalizumab, interferon β-1a 44 μg, or glatiramer acetate.', 'detailedDescription': "The protocol was amended in 15 March 2011 to discontinue participants' enrollment and efficacy assessments, and to offer the opportunity for participants already enrolled to continue receiving study treatment for their planned participation in the study. The study had been active in several countries for approximately 1 year, and enrollment had been significantly slower than expected. Thus, the decision was made by the Sponsor to terminate the study since current and projected future enrollment rates would not have provided valuable information in a reasonable timeframe. All clinical efficacy and magnetic resonance imaging (MRI) procedures were removed from the protocol, and safety assessments were to be managed through standard of care activities."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Have a diagnosis of relapsing remitting multiple sclerosis (MS) as defined by the revised McDonald Committee criteria (Polman 2005).\n2. Must have been treated with a stable regimen of either glatiramer acetate (20 mg per day subcutaneous) or interferon beta-1a (44 mcg 3 times per week subcutaneous) as their principal first therapy for MS for 6 to 18 months prior to randomization. (Note: prior treatment with another MS therapy of ≤ 30 days total duration is not exclusionary \\[e.g. titration to 44 mcg is allowed\\]).\n3. Have had disease activity within 12 months prior to screening while on therapy; disease activity must be observed after a minimum of 6 months on therapy. Qualifying disease activity is defined as:\n\n * One or more clinical relapses OR\n * Two or more new MRI lesions (gadolinium \\[Gd+\\] and/or T2 hyperintense) For inclusion purposes: (a) a relapse is defined as neurologic signs and/or symptoms documented in the medical record by a neurologist and of sufficient duration to be determined by the Investigator or the Treating Physician as consistent with an MS relapse or (b) MRI activity must be verified by the central reader center.\n4. Be naïve to natalizumab.\n5. Have a documented Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5, inclusive.\n\nKey Exclusion Criteria:\n\n1. Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.\n2. Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon beta-1a.\n3. Have had an MS exacerbation (relapse) within 30 days prior to randomization AND/OR the patient has not stabilized from a previous relapse, in the opinion of the Investigator, prior to randomization.\n4. The patient is considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or due to prior immunosuppressive or immunomodulating treatment.\n5. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, have suffered or are at risk for side effects from gadolinium (Gd), or have claustrophobia that cannot be medically managed.\n6. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical trial.\n7. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).\n8. Known history of human immunodeficiency virus (HIV).\n9. Positive test result for hepatitis C virus (test for hepatitis C virus antibody \\[HCVAb\\]) or hepatitis B virus (test for hepatitis B surface antigen \\[HBsAg\\] and/or hepatitis B core antibody \\[HBcAb\\]).\n10. History of transplantation or any anti-rejection therapy.\n11. History of progressive multifocal leukoencephalopathy (PML).\n\nNOTE: Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01058005', 'acronym': 'SURPASS', 'briefTitle': 'Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': '101MS325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Natalizumab', 'interventionNames': ['Drug: BG00002 (natalizumab)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon Beta-1a', 'interventionNames': ['Drug: interferon beta-1a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glatiramer Acetate', 'interventionNames': ['Drug: glatiramer acetate']}], 'interventions': [{'name': 'BG00002 (natalizumab)', 'type': 'DRUG', 'otherNames': ['Tysabri'], 'description': '300 mg intravenous injection every 4 weeks', 'armGroupLabels': ['Natalizumab']}, {'name': 'interferon beta-1a', 'type': 'DRUG', 'otherNames': ['Rebif'], 'description': '44 mcg subcutaneous injection 3 times per week', 'armGroupLabels': ['Interferon Beta-1a']}, {'name': 'glatiramer acetate', 'type': 'DRUG', 'otherNames': ['Copaxone'], 'description': '20 mg subcutaneous injection once daily', 'armGroupLabels': ['Glatiramer Acetate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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