Viewing Study NCT01412333

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Ignite Creation Date: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:26 AM
Study NCT ID: NCT01412333
Status: COMPLETED
Last Update Posted: 2024-03-08
First Post: 2011-08-08
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing 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', 'removedCountries': ['Colombia', 'Morocco']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'C533411', 'term': 'ocrelizumab'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to approximately 588 weeks', 'description': 'The safety population included all participants who received any study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon Beta-1a + Ocrelizumab Placebo (Double Blind)', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).', 'otherNumAtRisk': 417, 'deathsNumAtRisk': 417, 'otherNumAffected': 357, 'seriousNumAtRisk': 417, 'deathsNumAffected': 1, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Ocrelizumab + Interferon Beta-1a Placebo (Double Blind)', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.', 'otherNumAtRisk': 417, 'deathsNumAtRisk': 417, 'otherNumAffected': 360, 'seriousNumAtRisk': 417, 'deathsNumAffected': 1, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'Interferon Beta-1a + Ocrelizumab Placebo (Double Blind) Ocrelizumab (Open Label)', 'description': 'In DB phase participants received Interferon Beta-1a and Ocrelizumab Placebo. During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 297, 'otherNumAffected': 266, 'seriousNumAtRisk': 297, 'deathsNumAffected': 5, 'seriousNumAffected': 71}, {'id': 'EG003', 'title': 'Ocrelizumab + Interferon Beta-1a Placebo (Double Blind) Ocrelizumab (Open Label)', 'description': 'In DB phase participants received Ocrelizumab + Interferon Beta-1a Placebo. During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.', 'otherNumAtRisk': 350, 'deathsNumAtRisk': 350, 'otherNumAffected': 317, 'seriousNumAtRisk': 350, 'deathsNumAffected': 6, 'seriousNumAffected': 121}], 'otherEvents': [{'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 52, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 55, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 70, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 106, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 34, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 53, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 33, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 85, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 54, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 66, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 60, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 128, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 120, 'numAffected': 65}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 327, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 25, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 46, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 84, 'numAffected': 47}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 89, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 109, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 267, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 325, 'numAffected': 107}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 48, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 74, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 212, 'numAffected': 79}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 257, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 64, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 271, 'numAffected': 158}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 177, 'numAffected': 97}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 168, 'numAffected': 63}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 28, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 57, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 68, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 65, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 61, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 106, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 88, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 73, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 95, 'numAffected': 68}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 26, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 32, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 37, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 79, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 120, 'numAffected': 96}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 37, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HERPES ZOSTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 16, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 50, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 41, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 27, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 28, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 27, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NECK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 60, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 60, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 41, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 38, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MULTIPLE SCLEROSIS RELAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 150, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 157, 'numAffected': 82}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 39, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 43, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 89, 'numAffected': 58}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 28, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 27, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 59, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, 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{'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERSENSITIVITY PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LARYNGEAL OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PARANASAL SINUS INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PULMONARY INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'TONSILLAR INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'TRACHEAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DRUG ERUPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'STERILISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PERIPHERAL VENOUS DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'VARICOSE VEIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 350, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.290', 'groupId': 'OG000', 'lowerLimit': '0.234', 'upperLimit': '0.361'}, {'value': '0.155', 'groupId': 'OG001', 'lowerLimit': '0.121', 'upperLimit': '0.198'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.532', 'ciLowerLimit': '0.397', 'ciUpperLimit': '0.714', 'estimateComment': 'Rate ratio was calculated as Ocrelizumab ARR/Interferon beta-1a 44 mcg SC ARR.', 'groupDescription': 'Adjusted by Geographical Region (US vs. Rest of World) and baseline EDSS (\\<4.0 vs. \\>=4.0).', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.', 'unitOfMeasure': 'relapses/participant year of treatment', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median of time to onset of CDP was not achieved due to low number of participants with events. The full-range values are censored observations.', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '102'}, {'value': 'NA', 'comment': 'Median of time to onset of CDP was not achieved due to low number of participants with events. The lower-limit value is a censored observation.', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '104'}]}]}], 'analyses': [{'pValue': '= 0.0169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.92', 'groupDescription': 'Time to onset of CDP at week 12', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 104', 'description': 'Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \\>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\\<=) 5.5 B) \\>=0.5 point from the baseline EDSS score when the baseline score was \\>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '465', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate ratio', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '0.029', 'ciUpperLimit': '0.089', 'estimateComment': 'Adjusted by baseline T1 Gd lesion (present or not), baseline EDSS (\\<4.0 vs. \\>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '2103', 'groupId': 'OG000'}, {'value': '380', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate ratio', 'ciPctValue': '95', 'paramValue': '0.171', 'ciLowerLimit': '0.130', 'ciUpperLimit': '0.225', 'estimateComment': 'Adjusted by baseline T2 lesion count, baseline EDSS (\\<4.0 vs. \\>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '318', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.83', 'groupId': 'OG000', 'lowerLimit': '14.62', 'upperLimit': '23.65'}, {'value': '21.38', 'groupId': 'OG001', 'lowerLimit': '17.01', 'upperLimit': '26.30'}]}]}], 'analyses': [{'pValue': '= 0.4019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk (stratified)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.56', 'statisticalMethod': 'CMH Chi-Squared test (stratified)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by Geographical Region (US vs. Rest of World) and baseline EDSS (\\<4.0 vs. \\>=4.0).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \\>= 2.0. It was defined as a reduction in EDSS score of: A) \\>=1.0 from the baseline EDSS score when the baseline score was \\>=2 and \\<=5.5 B) \\>= 0.5 when the baseline EDSS score \\> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median of time to onset of CDP was not achieved due to low number of participants with events. The full-range values are censored observations.', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '102'}, {'value': 'NA', 'comment': 'Median of time to onset of CDP was not achieved due to low number of participants with events. The full-range values are censored observations.', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '104'}]}]}], 'analyses': [{'pValue': '= 0.037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.40', 'ciUpperLimit': '0.98', 'groupDescription': 'Time to onset of CDP at week 24', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 104', 'description': 'Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \\>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\\<=) 5.5 B) \\>=0.5 point from the baseline EDSS score when the baseline score was \\>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Number of T1 Hypointense Lesions During the Double-Blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '1484', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted rate ratio', 'ciPctValue': '95', 'paramValue': '0.357', 'ciLowerLimit': '0.272', 'ciUpperLimit': '0.47', 'estimateComment': 'Adjusted by baseline T1-hypointense lesion count, baseline EDSS (\\<4.0 vs. \\>=4.0) and geographical region (US vs. rest-of-world). Adjusted rate ratio was calculated as Ocrelizumab adjusted rate/Interferon beta-1a 44 mcg SC adjusted rate.', 'statisticalMethod': 'Negative Binomial Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96 In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'title': 'Unadjusted Baseline mean (n= 342, 358)', 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.026', 'spread': '0.034', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted Week 96 mean (n= 269, 308)', 'categories': [{'measurements': [{'value': '0.169', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.276', 'spread': '0.028', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.107', 'ciLowerLimit': '0.034', 'ciUpperLimit': '0.180', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.037', 'estimateComment': 'Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.', 'statisticalMethod': 'mixed-effect model of repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': 'MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96 In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.638', 'spread': '0.049', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.112', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.241', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.066', 'estimateComment': 'Difference in the rate of brain volume loss: 14.9%. Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.', 'statisticalMethod': 'mixed-effect model of repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix.'}], 'paramType': 'MEAN', 'timeFrame': 'From week 24 up to week 96', 'description': 'Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + (\\[percentage change in brain volume from baseline visit to Week 24\\]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (\\< 4.0 vs. \\>= 4.0) + Week + Treatment + Treatment\\*Week (repeated values over Week) + Brain Volume at Week 24\\*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96 In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'title': 'Unadjusted Baseline mean (n= 319, 355)', 'categories': [{'measurements': [{'value': '44.552', 'spread': '0.544', 'groupId': 'OG000'}, {'value': '44.307', 'spread': '0.541', 'groupId': 'OG001'}]}]}, {'title': 'Adjusted mean change at week 96(n=276, 315)', 'categories': [{'measurements': [{'value': '-0.833', 'spread': '0.472', 'groupId': 'OG000'}, {'value': '0.326', 'spread': '0.444', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.0404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.159', 'ciLowerLimit': '0.051', 'ciUpperLimit': '2.268', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.564', 'estimateComment': 'Difference in adjusted means was calculated as Ocrelizumab adjusted mean at Week 96/ Interferon beta-1a 44 mcg SC adjusted mean at Week 96.', 'statisticalMethod': 'mixed-effect model of repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Estimates are from analysis based on mixed-effect model of repeated measures using unstructured covariance matrix.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 96', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.', 'unitOfMeasure': 't-score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96 In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '29.6'}, {'value': '43.9', 'groupId': 'OG001', 'lowerLimit': '38.1', 'upperLimit': '49.9'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk (stratified)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.81', 'ciLowerLimit': '1.41', 'ciUpperLimit': '2.32', 'statisticalMethod': 'CMH Chi-Squared test (stratified)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Analyzed using CMH test, stratified by Geographical Region (US vs. rest-of-world) and baseline EDSS (\\<4.0 vs. \\>=4.0).'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'NEDA was defined only for participants with a baseline EDSS score \\>=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants in the study. Here, number of participants analysed signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}, {'value': '297', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a + Ocrelizumab Placebo (Double Blind Period)', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab + Interferon Beta-1a Placebo (Double Blind Period)', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}, {'id': 'OG002', 'title': 'Interferon Beta-1a + Placebo (Open Label Extension)', 'description': 'During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.'}, {'id': 'OG003', 'title': 'Ocrelizumab + Placebo (Open Label Extension)', 'description': 'During the OLE phase, all participants received ocrelizumab 600-mg IV infusion every 24 weeks.'}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '357', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}, {'value': '333', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 96', 'description': 'AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any study drug.'}, {'type': 'SECONDARY', 'title': 'Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC) In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'categories': [{'measurements': [{'value': '3513', 'spread': '955', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96', 'description': 'AUC represents total drug exposure for one dosing interval after the 4th dose.', 'unitOfMeasure': 'micrograms per milliter*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab In Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'OG001', 'title': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'classes': [{'title': 'Positive sample at baseline (n= 407, 402)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Positive for ADA post-baseline (n= 403, 405)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 96', 'description': 'Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon Beta-1a + Ocrelizumab Placebo', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'FG001', 'title': 'Ocrelizumab + Interferon Beta-1a Placebo', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '417'}]}, {'type': 'Entered OLE Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '350'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '192'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 1045 participants were screened for entry into the study. Of these, 210 participants failed screening; the main reasons were failure to meet the inclusion/exclusion criteria or unacceptable laboratory values. A total of 835 participants were enrolled in the study.', 'preAssignmentDetails': "All participants were provided an opportunity to rollover and continue treatment and/or safety follow-up under the new extension protocol MN43964. In error, the study completion status for 5 participants was registered as 'Sponsor Termination' in the study eCRF. All 5 participants opted not to be enrolled into MN43964 and decided to pursue treatment outside the context of a clinical trial. In conclusion, the 5 participants should be considered as having completed the WA21093 study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'BG000'}, {'value': '417', 'groupId': 'BG001'}, {'value': '835', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon Beta-1a + Ocrelizumab Placebo (Double Blind Period)', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, {'id': 'BG001', 'title': 'Ocrelizumab + Interferon Beta-1a Placebo (Double Blind Period)', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '37.3', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-19', 'size': 3810328, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-18T16:18', 'hasProtocol': True}, {'date': '2023-03-20', 'size': 982891, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-18T16:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 835}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'dispFirstSubmitDate': '2016-10-21', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2011-08-08', 'dispFirstSubmitQcDate': '2016-10-25', 'resultsFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2011-08-08', 'dispFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-17', 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks In Double Blind Period', 'timeFrame': 'Week 96', 'description': 'ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period', 'timeFrame': 'Week 104', 'description': 'Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \\>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\\<=) 5.5 B) \\>=0.5 point from the baseline EDSS score when the baseline score was \\>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.'}, {'measure': 'Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.'}, {'measure': 'Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.'}, {'measure': 'Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks In Double Blind Period', 'timeFrame': 'Week 96', 'description': 'Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of \\>= 2.0. It was defined as a reduction in EDSS score of: A) \\>=1.0 from the baseline EDSS score when the baseline score was \\>=2 and \\<=5.5 B) \\>= 0.5 when the baseline EDSS score \\> 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.'}, {'measure': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period', 'timeFrame': 'Week 104', 'description': 'Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) \\>=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (\\<=) 5.5 B) \\>=0.5 point from the baseline EDSS score when the baseline score was \\>5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.'}, {'measure': 'Number of T1 Hypointense Lesions During the Double-Blind Treatment', 'timeFrame': 'Baseline up to week 96', 'description': 'The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.'}, {'measure': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96 In Double Blind Period', 'timeFrame': 'Baseline, Week 96', 'description': 'MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.'}, {'measure': 'Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96 In Double Blind Period', 'timeFrame': 'From week 24 up to week 96', 'description': 'Brain volume was recorded as an absolute "normalized" value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + (\\[percentage change in brain volume from baseline visit to Week 24\\]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (\\< 4.0 vs. \\>= 4.0) + Week + Treatment + Treatment\\*Week (repeated values over Week) + Brain Volume at Week 24\\*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).'}, {'measure': 'Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96 In Double Blind Period', 'timeFrame': 'Baseline, Week 96', 'description': 'The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.'}, {'measure': 'Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96 In Double Blind Period', 'timeFrame': 'Week 96', 'description': 'NEDA was defined only for participants with a baseline EDSS score \\>=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to Week 96', 'description': 'AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.'}, {'measure': 'Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC) In Double Blind Period', 'timeFrame': 'Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96', 'description': 'AUC represents total drug exposure for one dosing interval after the 4th dose.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab In Double Blind Period', 'timeFrame': 'Baseline up to Week 96', 'description': 'Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '40629721', 'type': 'DERIVED', 'citation': 'Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8.'}, {'pmid': '40554392', 'type': 'DERIVED', 'citation': 'Montobbio N, Bovis F, Signori A, Carmisciano L, Schiavetti I, Ponzano M, Tur C, Granziera C, Cagol A, Arnold DL, Kappos L, Sormani MP. Uncovering a bias in estimated treatment effects on PIRA in multiple sclerosis clinical trials. EBioMedicine. 2025 Jul;117:105802. doi: 10.1016/j.ebiom.2025.105802. Epub 2025 Jun 18.'}, {'pmid': '40258203', 'type': 'DERIVED', 'citation': 'Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.'}, {'pmid': '39965438', 'type': 'DERIVED', 'citation': 'Benedict RH, Kappos L, Miller A, Hartung HP, Overell J, Pei J, Dahlke F, Bernasconi C, Koendgen H, Wang Q, Bonati U, Cohan S. Cognitive effects of ocrelizumab vs interferon beta-1a in relapsing multiple sclerosis: A post hoc analysis of the OPERA I/II trials. Mult Scler Relat Disord. 2025 Mar;95:106310. doi: 10.1016/j.msard.2025.106310. Epub 2025 Feb 2.'}, {'pmid': '39290861', 'type': 'DERIVED', 'citation': 'Muros-Le Rouzic E, Heer Y, Yiu S, Tozzi V, Braune S, van Hovell P, Bergmann A, Bernasconi C, Model F, Craveiro L; NTD study group. Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments. J Cent Nerv Syst Dis. 2024 Sep 13;16:11795735241260563. doi: 10.1177/11795735241260563. eCollection 2024.'}, {'pmid': '37652990', 'type': 'DERIVED', 'citation': 'Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.'}, {'pmid': '37148240', 'type': 'DERIVED', 'citation': 'Kolind S, Gaetano L, Assemlal HE, Bernasconi C, Bonati U, Elliott C, Hagenbuch N, Magon S, Arnold DL, Traboulsee A. Ocrelizumab-treated patients with relapsing multiple sclerosis show volume loss rates similar to healthy aging. Mult Scler. 2023 May;29(6):741-747. doi: 10.1177/13524585231162586. Epub 2023 May 6.'}, {'pmid': '36792367', 'type': 'DERIVED', 'citation': 'Hauser SL, Bar-Or A, Weber MS, Kletzl H, Gunther A, Manfrini M, Model F, Mercier F, Petry C, Wing Q, Koendgen H, Smith T, Kappos L. Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2023 Feb 15;10(2):e200094. doi: 10.1212/NXI.0000000000200094. Print 2023 Mar.'}, {'pmid': '36163349', 'type': 'DERIVED', 'citation': 'Falet JR, Durso-Finley J, Nichyporuk B, Schroeter J, Bovis F, Sormani MP, Precup D, Arbel T, Arnold DL. Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning. Nat Commun. 2022 Sep 26;13(1):5645. doi: 10.1038/s41467-022-33269-x.'}, {'pmid': '35672926', 'type': 'DERIVED', 'citation': 'Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.'}, {'pmid': '34904871', 'type': 'DERIVED', 'citation': 'Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.'}, {'pmid': '33724637', 'type': 'DERIVED', 'citation': 'Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.'}, {'pmid': '32690791', 'type': 'DERIVED', 'citation': 'Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.'}, {'pmid': '32511687', 'type': 'DERIVED', 'citation': 'Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.'}, {'pmid': '28002679', 'type': 'DERIVED', 'citation': 'Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)\n* At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)\n* Neurologic stability for greater than or equal to (\\>/=) 30 days prior to both screening and baseline\n* Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive\n\nExclusion Criteria:\n\n* Primary progressive multiple sclerosis\n* Disease duration of more than 10 years in patients with EDSS score less than or equal to (\\</=) 2.0 at screening\n* Contraindications for MRI\n* Known presence of other neurological disorders which may mimic multiple sclerosis\n* Pregnancy or lactation\n* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* History of or currently active primary or secondary immunodeficiency\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus \\[HIV\\], syphilis, tuberculosis)\n* History of progressive multifocal leukoencephalopathy\n* Contraindications to or intolerance of oral or IV corticosteroids\n* Contraindications to Rebif or incompatibility with Rebif use'}, 'identificationModule': {'nctId': 'NCT01412333', 'briefTitle': 'A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'WA21093'}, 'secondaryIdInfos': [{'id': '2010-020315-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon beta-1a 44 mcg SC', 'description': 'Interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).', 'interventionNames': ['Drug: Interferon beta-1a', 'Drug: Ocrelizumab-matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab', 'description': 'Ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week.', 'interventionNames': ['Drug: Ocrelizumab', 'Drug: Interferon beta-1a-matching placebo']}], 'interventions': [{'name': 'Interferon beta-1a', 'type': 'DRUG', 'otherNames': ['Rebif'], 'armGroupLabels': ['Interferon beta-1a 44 mcg SC']}, {'name': 'Ocrelizumab-matching placebo', 'type': 'DRUG', 'armGroupLabels': ['Interferon beta-1a 44 mcg SC']}, {'name': 'Ocrelizumab', 'type': 'DRUG', 'otherNames': ['RO4964913'], 'armGroupLabels': ['Ocrelizumab']}, {'name': 'Interferon beta-1a-matching placebo', 'type': 'DRUG', 'armGroupLabels': ['Ocrelizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85050', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Hope Research Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Neurology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Territory Neurology and Research Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Research, LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80262', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research LLC', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists of Southern CT PC', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Infinity Clinical Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami; Dept. of Neurology MS Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Services of Orlando', 'geoPoint': {'lat': 28.53834, 'lon': 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'country': 'United States', 'facility': 'MidAmerica Neuroscience Institute', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '40513', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Associates in Neurology PSC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02481', 'city': 'Wellesley', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dragonfly Research, LLC', 'geoPoint': {'lat': 42.29649, 'lon': -71.29256}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48109-0666', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University; Department of Neurology', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'The Minneapolis Clinic of Neurology', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers New Jersey Medical School', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Hospital', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'MS Comprehensive Care Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Shore Neurology', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '12210', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'Empire Neurology, PC', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}, {'zip': '63110', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore Neurologic Associates P.C.', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY at Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Neurological Institute PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Neurology Associates PA', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27607-6520', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '43801', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Columbus Neuroscience', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 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