Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-05 @ 2:07 PM
Study NCT ID:
NCT00548405
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}], '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': 'Contact-us@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'PI can publish after sponsor published, after a defined period of time after study completion, and/or with written Sponsor approval. Generally PI gives sponsor a draft 60 days before publication. Sponsor can ask that confidential information can be removed, and can further defer publication upon notifying PI that it will file a patent application on inventions contained in the draft.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Efficacy analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.'}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug up to 2 years', 'description': 'If a participant experienced a serious and a non-serious event with same term, individual was included in numerator of both adverse event tables. Safety population: all participants who received any amount of study drug (as treated). In Alemtuzumab 24 mg arm 9 participants received Alemtuzumab 12 mg, hence were included in Alemtuzumab 12 mg arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon Beta-1a', 'description': "Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.", 'otherNumAtRisk': 202, 'otherNumAffected': 189, 'seriousNumAtRisk': 202, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.', 'otherNumAtRisk': 435, 'otherNumAffected': 427, 'seriousNumAtRisk': 435, 'seriousNumAffected': 85}, {'id': 'EG002', 'title': 'Alemtuzumab 24 mg', 'description': 'Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.', 'otherNumAtRisk': 161, 'otherNumAffected': 159, 'seriousNumAtRisk': 161, 'seriousNumAffected': 30}, {'id': 'EG003', 'title': 'Alemtuzumab (Pooled)', 'description': 'Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.', 'otherNumAtRisk': 596, 'otherNumAffected': 586, 'seriousNumAtRisk': 596, 'seriousNumAffected': 115}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 30}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 156}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 94}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 141}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 180}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 44}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 78}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 104}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 129}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 80}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 38}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CD4 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 32}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CD8 lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'T-lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 83}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 82}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 40}], 'organSystem': 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{'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 202, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 596, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Accumulation of Disability (SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.13', 'groupId': 'OG000', 'lowerLimit': '15.95', 'upperLimit': '27.68'}, {'value': '12.71', 'groupId': 'OG001', 'lowerLimit': '9.89', 'upperLimit': '16.27'}]}]}], 'analyses': [{'pValue': '0.0084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.87', 'pValueComment': 'Hochberg method was used to adjust for the two co-primary outcomes.', 'groupDescription': 'Cox proportional hazards (PH) regression model with robust variance estimation using treatment group and geographic region as covariate was used.', 'statisticalMethod': 'Cox Proportional Hazards Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who received at least 1 dose of study drug as per initial randomization. Analysis was not performed for Alemtuzumab 24 mg as recruitment to this arm was closed early to reduce overall sample size, duration of enrollment period, overall duration of study.'}, {'type': 'PRIMARY', 'title': 'Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.41', 'upperLimit': '0.66'}, {'value': '0.26', 'groupId': 'OG001', 'lowerLimit': '0.21', 'upperLimit': '0.33'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.39', 'ciUpperLimit': '0.65', 'pValueComment': 'Hochberg method was used to adjust for the two co-primary outcomes.', 'groupDescription': 'Proportional means regression model with robust variance estimation and covariate adjustment for geographic region was used.', 'statisticalMethod': 'Proportional means regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.', 'unitOfMeasure': 'relapses per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Relapse Free at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.70', 'groupId': 'OG000', 'lowerLimit': '39.53', 'upperLimit': '53.54'}, {'value': '65.38', 'groupId': 'OG001', 'lowerLimit': '60.65', 'upperLimit': '69.70'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.41', 'ciUpperLimit': '0.69', 'groupDescription': 'Cox PH regression model with robust variance estimation and covariate adjustment for geographic region was used.', 'statisticalMethod': 'Cox Proportional Hazards Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 2', 'description': 'Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'spread': '1.167', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '1.084', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.', 'statisticalMethod': 'Wei-Lachin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 2', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Here, number of participants analyzed was subset of FAS who had EDSS assessment at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'title': 'Baseline (n=198, 423)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.791', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.689', 'groupId': 'OG001'}]}]}, {'title': 'Change at Year 2 (n=169, 399)', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.449', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.358', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change at Year 2: the analysis was performed using Wei-Lachin method for non-parametric analysis of repeated measures.', 'statisticalMethod': 'Wei-Lachin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 2', 'description': 'MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population. Here, number of participants analyzed signifies subset of FAS who had MSFC score assessment at Baseline; 'n' signifies participants who had MSFC score assessment at Baseline (for Baseline) and at both Baseline and Year 2 (for change at Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': "Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.41', 'spread': '26.48', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '24.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1371', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Ranked ANCOVA models with covariate adjustment for geographic region and Baseline T2 lesion volume was used.', 'statisticalMethod': 'Ranked ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 2', 'description': 'Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)\\*100/ (lesion volume at Baseline).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Here, number of participants analyzed was subset of FAS who had assessment for T2 volume at both Baseline and end-of-study (Year 2). Analysis was not performed for Alemtuzumab 24 mg as described in outcome measure 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon Beta-1a', 'description': "Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'FG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.'}, {'id': 'FG002', 'title': 'Alemtuzumab 24mg', 'description': 'Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized.', 'groupId': 'FG000', 'numSubjects': '231'}, {'comment': 'Randomized.', 'groupId': 'FG001', 'numSubjects': '436'}, {'comment': 'Randomized.', 'groupId': 'FG002', 'numSubjects': '173'}]}, {'type': 'Treated', 'achievements': [{'comment': 'All randomized participants who received at least 1 dose of study drug as per initial randomization.', 'groupId': 'FG000', 'numSubjects': '202'}, {'comment': 'All randomized participants who received at least 1 dose of study drug as per initial randomization.', 'groupId': 'FG001', 'numSubjects': '426'}, {'comment': 'All randomized participants who received at least 1 dose of study drug as per initial randomization.', 'groupId': 'FG002', 'numSubjects': '170'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '416'}, {'groupId': 'FG002', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were screened at 192 investigational sites between October 10, 2007 and September 15, 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'BG000'}, {'value': '426', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '798', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon Beta-1a', 'description': "Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion."}, {'id': 'BG001', 'title': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.'}, {'id': 'BG002', 'title': 'Alemtuzumab 24mg', 'description': 'Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '8.77', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '35.1', 'spread': '8.40', 'groupId': 'BG002'}, {'value': '35.1', 'spread': '8.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '532', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '266', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time Since First Relapse', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '10.1'}, {'value': '3.8', 'groupId': 'BG001', 'lowerLimit': '0.2', 'upperLimit': '14.4'}, {'value': '3.7', 'groupId': 'BG002', 'lowerLimit': '0.2', 'upperLimit': '16.9'}, {'value': '3.8', 'groupId': 'BG003', 'lowerLimit': '0.2', 'upperLimit': '16.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Number of Relapse Episodes in the Preceding 2 Years', 'classes': [{'title': '1 Relapse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}, {'title': '2 Relapses', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '418', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to 3 Relapses', 'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '347', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants with 1, 2 or greater than or equal to 3 relapses are reported.', 'unitOfMeasure': 'participants'}, {'title': 'Expanded Disability Status Scale (EDSS) Score', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '1.26', 'groupId': 'BG001'}, {'value': '2.7', 'spread': '1.17', 'groupId': 'BG002'}, {'value': '2.7', 'spread': '1.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'EDSS is an ordinal scale in half-point increments that quantifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study drug as per initial randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2012-11-30', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2007-10-22', 'dispFirstSubmitQcDate': '2012-11-30', 'resultsFirstSubmitDate': '2014-11-17', 'studyFirstSubmitQcDate': '2007-10-22', 'dispFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-06', 'studyFirstPostDateStruct': {'date': '2007-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Accumulation of Disability (SAD)', 'timeFrame': 'Up to 2 years', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with a Baseline score of 1.0 or more; and the increase persisted for at least the next 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Percentage of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.'}, {'measure': 'Annualized Relapse Rate', 'timeFrame': 'Up to 2 years', 'description': 'Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated through negative binomial regression with robust variance estimation and covariate adjustment for geographic region using observed number of relapses as dependent variable, the log total amount of follow-up from date of first study treatment for each participant as an offset variable, and treatment group and geographic region as model covariates.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Were Relapse Free at Year 2', 'timeFrame': 'Year 2', 'description': 'Participants were considered relapse free at Year 2 if they did not experience a relapse from the date of first study treatment to study completion at 24 months. Percentage of participants who were relapse free at Year 2, estimated using the KM method, was reported.'}, {'measure': 'Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Year 2', 'timeFrame': 'Baseline, Year 2', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It assesses the 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Change was calculated by subtracting Baseline value from value at Year 2.'}, {'measure': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score at Year 2', 'timeFrame': 'Baseline, Year 2', 'description': 'MSFC is a multidimensional measure consisting of quantitative tests of ambulation (Timed 25-Foot Walk), manual dexterity (9-Hole Peg Test; 9HPT), and cognitive function (Paced Auditory Serial Addition Test; PASAT). The MSFC score was calculated as the mean of the Z-scores of the 3 components. A Z-score was calculated by subtracting the mean of the reference population from the test result, then dividing by the standard deviation of the reference population. Higher Z-scores reflected better neurological function and a positive change from Baseline indicates improvement. An increase in score indicated an improvement (Z-score range: -3 to +3). Acquisition of disability was measured by change from Baseline in MSFC score at Year 2.'}, {'measure': 'Percent Change From Baseline in Magnetic Resonance Imaging Time Constant 2 (MRI-T2) Hyperintense Lesion Volume at Year 2', 'timeFrame': 'Baseline, Year 2', 'description': 'Percent change in MS lesion volume as measured by MRI-T2 scan was calculated from MRI-T2-weighted scans as the following: (lesion volume at 2 years - lesion volume at Baseline)\\*100/ (lesion volume at Baseline).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'references': [{'pmid': '23122650', 'type': 'BACKGROUND', 'citation': 'Coles AJ, Twyman CL, Arnold DL, Cohen JA, Confavreux C, Fox EJ, Hartung HP, Havrdova E, Selmaj KW, Weiner HL, Miller T, Fisher E, Sandbrink R, Lake SL, Margolin DH, Oyuela P, Panzara MA, Compston DA; CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012 Nov 24;380(9856):1829-39. doi: 10.1016/S0140-6736(12)61768-1. Epub 2012 Nov 1.'}, {'pmid': '39935588', 'type': 'DERIVED', 'citation': 'Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025.'}, {'pmid': '37745914', 'type': 'DERIVED', 'citation': 'Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/17562864231194823. eCollection 2023.'}, {'pmid': '37272540', 'type': 'DERIVED', 'citation': 'Riera R, Torloni MR, Martimbianco ALC, Pacheco RL. Alemtuzumab for multiple sclerosis. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD011203. doi: 10.1002/14651858.CD011203.pub3.'}, {'pmid': '36619856', 'type': 'DERIVED', 'citation': 'Dayan CM, Lecumberri B, Muller I, Ganesananthan S, Hunter SF, Selmaj KW, Hartung HP, Havrdova EK, LaGanke CC, Ziemssen T, Van Wijmeersch B, Meuth SG, Margolin DH, Poole EM, Baker DP, Senior PA. Endocrine and multiple sclerosis outcomes in patients with autoimmune thyroid events in the alemtuzumab CARE-MS studies. Mult Scler J Exp Transl Clin. 2023 Jan 3;9(1):20552173221142741. doi: 10.1177/20552173221142741. eCollection 2023 Jan-Mar.'}, {'pmid': '34882037', 'type': 'DERIVED', 'citation': 'Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.'}, {'pmid': '34035833', 'type': 'DERIVED', 'citation': 'Coles AJ, Arnold DL, Bass AD, Boster AL, Compston DAS, Fernandez O, Havrdova EK, Nakamura K, Traboulsee A, Ziemssen T, Jacobs A, Margolin DH, Huang X, Daizadeh N, Chirieac MC, Selmaj KW. Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial. Ther Adv Neurol Disord. 2021 Apr 23;14:1756286420982134. doi: 10.1177/1756286420982134. eCollection 2021.'}, {'pmid': '33414927', 'type': 'DERIVED', 'citation': 'Horakova D, Boster A, Bertolotto A, Freedman MS, Firmino I, Cavalier SJ, Jacobs AK, Thangavelu K, Daizadeh N, Poole EM, Baker DP, Margolin DH, Ziemssen T; CARE-MS I, CARE-MS II, and CAMMS03409 Investigators. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020 Dec 18;6(4):2055217320972137. doi: 10.1177/2055217320972137. eCollection 2020 Oct-Dec.'}, {'pmid': '32710396', 'type': 'DERIVED', 'citation': 'Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.'}, {'pmid': '32539719', 'type': 'DERIVED', 'citation': 'Gilmore W, Lund BT, Li P, Levy AM, Kelland EE, Akbari O, Groshen S, Cen SY, Pelletier D, Weiner LP, Javed A, Dunn JE, Traboulsee AL. Repopulation of T, B, and NK cells following alemtuzumab treatment in relapsing-remitting multiple sclerosis. J Neuroinflammation. 2020 Jun 15;17(1):189. doi: 10.1186/s12974-020-01847-9.'}, {'pmid': '31762387', 'type': 'DERIVED', 'citation': 'Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.'}, {'pmid': '31675266', 'type': 'DERIVED', 'citation': 'Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernandez O, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1.'}, {'pmid': '31654272', 'type': 'DERIVED', 'citation': 'Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.'}, {'pmid': '31144568', 'type': 'DERIVED', 'citation': 'Arroyo R, Bury DP, Guo JD, Margolin DH, Melanson M, Daizadeh N, Cella D. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020 Jul;26(8):955-963. doi: 10.1177/1352458519849796. Epub 2019 May 30.'}, {'pmid': '30144037', 'type': 'DERIVED', 'citation': 'Li Z, Richards S, Surks HK, Jacobs A, Panzara MA. Clinical pharmacology of alemtuzumab, an anti-CD52 immunomodulator, in multiple sclerosis. Clin Exp Immunol. 2018 Dec;194(3):295-314. doi: 10.1111/cei.13208. Epub 2018 Oct 1.'}, {'pmid': '27590291', 'type': 'DERIVED', 'citation': 'Arnold DL, Fisher E, Brinar VV, Cohen JA, Coles AJ, Giovannoni G, Hartung HP, Havrdova E, Selmaj KW, Stojanovic M, Weiner HL, Lake SL, Margolin DH, Thomas DR, Panzara MA, Compston DA; CARE-MS I and CARE-MS II Investigators. Superior MRI outcomes with alemtuzumab compared with subcutaneous interferon beta-1a in MS. Neurology. 2016 Oct 4;87(14):1464-1472. doi: 10.1212/WNL.0000000000003169. Epub 2016 Sep 2.'}, {'pmid': '25111080', 'type': 'DERIVED', 'citation': 'Grafals M, Smith B, Murakami N, Trabucco A, Hamill K, Marangos E, Gilligan H, Pomfret EA, Pomposelli JJ, Simpson MA, Azzi J, Najafian N, Riella LV. Immunophenotyping and efficacy of low dose ATG in non-sensitized kidney recipients undergoing early steroid withdrawal: a randomized pilot study. PLoS One. 2014 Aug 11;9(8):e104408. doi: 10.1371/journal.pone.0104408. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.', 'detailedDescription': 'Every participant received active treatment; there was no placebo. After Amendment 2, the 24 mg alemtuzumab dose was closed to enrollment so newly enrolled participants were randomly assigned to treatment with either 12 mg alemtuzumab or interferon beta-1a in a 2:1 ratio (that is, 2 given 12 mg alemtuzumab for every 1 given interferon beta-1a). Alemtuzumab was administered in two annual courses, once at the beginning of the study and again 1 year later. Interferon beta-1a was self-injected 3 times per week for 2 years. All participants were required to return to their study site every 3 months for neurologic assessment. In addition, safety-related laboratory tests were performed at least monthly. Participation in this study ended 2 years after the start of treatment for each participant. Additionally, participants who received alemtuzumab might be followed in the CAMMS03409 Extension Study (NCT00930553) for safety and efficacy assessments. Participants who received interferon beta-1a and completed 2 years on study might be eligible to receive alemtuzumab in the Extension Study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent form (ICF)\n* Age 18 to 55 years (inclusive) as of the date the ICF was signed\n* Diagnosis of MS per update of McDonald criteria\n* Onset of MS symptoms (as determined by a neurologist; could be retrospectively) within 10 years of the date the ICF was signed\n* Expanded Disability Status Scale (EDSS) score 0.0 to 5.0 (inclusive) at Screening\n* Greater than or equal to (\\>=) 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF was signed, with \\>=1 attack in the 12 months prior to the date the ICF was signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other Genzyme-approved health-care provider and the objective signs could be identified retrospectively\n* \\>=1 MS relapse during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for \\>=6 months within 10 years of the date the ICF was signed\n* MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist: \\>=9 time constant 2 (T2) lesions at least 3 millimeter (mm) in any axis; a gadolinium- (Gd-) enhancing lesion at least 3 mm in any axis plus \\>=1 brain T2 lesions; and a spinal cord lesion consistent with MS plus \\>=1 brain T2 lesion\n\nExclusion Criteria:\n\n* Received prior therapy with alemtuzumab\n* Current participation in another clinical study or previous participation in CAMMS323 (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, CARE-MS I)\n* Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Participants who received one of these medications more than 6 months before the date the ICF was signed were eligible for study entry if approval was granted by Genzyme\n* Any progressive form of MS\n* History of malignancy (except basal skin cell carcinoma)\n* CD4 +, CD8 +, CD19 + (that is, absolute CD3 + CD4 + , CD3 + CD8 + , or CD19 + /mm 3 ) count, absolute neutrophil count less than (\\<) lower limit of normal (LLN) at screening; if abnormal cell count(s) returned to within normal limits (WNL), eligibility could be reassessed\n* Known bleeding disorder (for example, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation, fibrinogen deficiency, or clotting factor deficiency)\n* Significant autoimmune disease including but not limited to immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis\n* Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (that is, above the LLN)\n* Active infection or at high risk for infection"}, 'identificationModule': {'nctId': 'NCT00548405', 'acronym': 'CARE-MS II', 'briefTitle': 'Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy', 'orgStudyIdInfo': {'id': 'CAMMS32400507'}, 'secondaryIdInfos': [{'id': '2007-001162-32', 'type': 'EUDRACT_NUMBER'}, {'id': 'CAMMS324,'}, {'id': 'ISRCTN70702834', 'type': 'REGISTRY', 'domain': 'ISRCTN'}, {'id': 'ACTRN12608000426381', 'type': 'REGISTRY', 'domain': 'ANZCTR'}, {'id': 'NTR1469', 'type': 'REGISTRY', 'domain': 'The Netherlands National Trial Register'}, {'id': 'CARE-MS II', 'type': 'OTHER', 'domain': 'NMSS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab 12 mg', 'description': 'Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.', 'interventionNames': ['Biological: Alemtuzumab 12 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab 24 mg', 'description': 'Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.', 'interventionNames': ['Biological: Alemtuzumab 24 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon Beta-1a', 'description': "Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.", 'interventionNames': ['Biological: Interferon beta-1a']}], 'interventions': [{'name': 'Alemtuzumab 12 mg', 'type': 'BIOLOGICAL', 'otherNames': ['Lemtrada'], 'description': 'Alemtuzumab 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.', 'armGroupLabels': ['Alemtuzumab 12 mg']}, {'name': 'Alemtuzumab 24 mg', 'type': 'BIOLOGICAL', 'otherNames': ['Lemtrada'], 'description': 'Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.', 'armGroupLabels': ['Alemtuzumab 24 mg']}, {'name': 'Interferon beta-1a', 'type': 'BIOLOGICAL', 'otherNames': ['Rebif®'], 'description': "Interferon beta-1a 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.", 'armGroupLabels': ['Interferon Beta-1a']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, P.C.', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Barrow Neurological Institute, St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona, Department of Neurology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Physicians Medical Group/Sutter East Bay Medical Foundation', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'city': 'La Habra', 'state': 'California', 'country': 'United States', 'facility': 'Neurology Center of North Orange County', 'geoPoint': {'lat': 33.93196, 'lon': -117.94617}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Department of Neurology, Keck School of Medicine, University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Therapeutics Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Therapeutics, Inc', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital, Anschutz Outpatient Pavilioin', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Neurological Consultants', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Neuroscience Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, P.A.', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Associates', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Negroski, Stein, Sutherland and Hanes Neurology', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Axiom Clinical Research of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Department of Neurology', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Department of Neurology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Falls Multiple Sclerosis Center, PLLC', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center, Department of Neurology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Northbrook', 'state': 'Illinois', 'country': 'United States', 'facility': 'Consultants in Neurology, Ltd', 'geoPoint': {'lat': 42.12753, 'lon': -87.82895}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine, Department of Neurology', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Josephson Wallack Munshower Neurology P.C.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Health Physicians', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Ruan Neurology Clinic and Research Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center, Department of Neurology', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'MidAmerica Neuroscience Institute', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Associates in Neurology, PSC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Research Foundation', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United 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