Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2025-12-28 @ 9:39 PM
Study NCT ID:
NCT04075266
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2019-08-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533411', 'term': 'ocrelizumab'}]}}, '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': 'Up to 3.7 years', 'description': 'Safety population included all participants who received at least one dose of study drug. Data collected up to the primary completion date is reported here. Adverse events section will be updated one year after the study completion date.', 'eventGroups': [{'id': 'EG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Monocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Nasal herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 45, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Product preparation error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Torus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Gonococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Body Weight < 40 kg', 'description': 'Participants who weighed \\< 40 kg were administered first dose of 300 mg ocrelizumab as two IV 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The data for the PK parameter: Cmax was collected and analyzed as per body weight range (\\<40kg to ≥40 kg).', 'unitOfMeasure': 'microgram/milliters (µg/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Dose Exploration Period: Levels of CD 19+ B-cell Count in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.00', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '404.0'}, {'value': '9.00', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '151.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 24', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 7 years', 'description': 'An AE is untoward medical occurrence in participant administered a pharmaceutical product \\& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \\& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'title': 'CD3+ Total T cell', 'categories': [{'measurements': [{'value': '1637.67', 'spread': '578.50', 'groupId': 'OG000'}, {'value': '1506.0', 'spread': '468.68', 'groupId': 'OG001'}]}]}, {'title': 'CD4+ Helper T cell', 'categories': [{'measurements': [{'value': '1044.0', 'spread': '329.0', 'groupId': 'OG000'}, {'value': '889.18', 'spread': '252.58', 'groupId': 'OG001'}]}]}, {'title': 'CD8+ Cytotoxic T cell', 'categories': [{'measurements': [{'value': '441.83', 'spread': '180.32', 'groupId': 'OG000'}, {'value': '532.65', 'spread': '218.52', 'groupId': 'OG001'}]}]}, {'title': 'NK cells', 'categories': [{'measurements': [{'value': '266.5', 'spread': '182.97', 'groupId': 'OG000'}, {'value': '237.76', 'spread': '118.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 24', 'unitOfMeasure': 'cells/microliter (µL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Level of Circulating T Cells and NK Cells', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'title': 'Lymphocyte', 'categories': [{'measurements': [{'value': '1.792', 'spread': '0.660', 'groupId': 'OG000'}, {'value': '1.668', 'spread': '0.507', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophil', 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.567', 'groupId': 'OG000'}, {'value': '2.857', 'spread': '0.762', 'groupId': 'OG001'}]}]}, {'title': 'Monocyte', 'categories': [{'measurements': [{'value': '0.328', 'spread': '0.151', 'groupId': 'OG000'}, {'value': '0.343', 'spread': '0.114', 'groupId': 'OG001'}]}]}, {'title': 'Leukocyte', 'categories': [{'measurements': [{'value': '4.87', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '1.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 24', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Developmental Milestones - Growth Velocity: Change in Height', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Developmental Milestones: Bone Age Assessment by Wrist/Hand Radiographs', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Developmental Milestones: Male and Female Puberty Assessed by Tanner Staging', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Developmental Milestones: Age at Menarche, Related With the Female Reproductive Status', 'timeFrame': 'Up to 7 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Number of Participants With Shift From Baseline in Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'The change in the non-MS CNS pathology was assessed using MRI scans.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Number of Participants With Shift From Baseline in Non-MS CNS Pathology as Measured by Brain MRI', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Levels of Blood Immunoglobulins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'title': 'Total Immunoglobulin', 'categories': [{'measurements': [{'value': '11.23', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '11.86', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'Immunoglobulin A', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Immunoglobulin G', 'categories': [{'measurements': [{'value': '9.25', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '9.73', 'spread': '2.51', 'groupId': 'OG001'}]}]}, {'title': 'Immunoglobulin M', 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 24', 'unitOfMeasure': 'gram/liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Levels of Blood Immunoglobulins', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'title': 'Mumps', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pneumococcal Capsular Polysaccharides', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Rubella', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Varicella-Zoster Virus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 24', 'description': 'Measurement of antibody titers to common antigens (mumps, rubella, varicella, and Streptococcus pneumoniae \\[S. pneumoniae\\]) were performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Number of Participants With Antibody Titers Against Standard Vaccines', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}, {'type': 'SECONDARY', 'title': 'Dose Exploration Period: Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'OG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug. Overall number analyzed is the number of participants with data available for analysis at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'OOE Period: Number of Participants With ADAs to Ocrelizumab', 'timeFrame': 'Up to 5 years', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2030-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kilograms (kg) to 40 kg were administered first dose of 300 milligrams (mg) ocrelizumab as two intravenous (IV) infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week optional ocrelizumab extension (OOE) period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'FG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}], 'periods': [{'title': 'Dose Exploration Period: 24 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'OOE Period: 264 Week', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed the dose exploration period were given the option to enroll in the OOE period to receive ocrelizumab.', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': 'Participants who completed the dose exploration period were given the option to enroll in the OOE period to receive ocrelizumab.', 'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Ongoing in Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study across 12 investigative sites in 3 countries (the United States, Poland, and Italy). This study is still ongoing.', 'preAssignmentDetails': 'A total of 23 participants with relapsing-remitting multiple sclerosis (RRMS) received ocrelizumab per a weight-based dosing regimen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ocrelizumab 300 mg', 'description': 'Participants who weighed between 25 kg to 40 kg were administered first dose of 300 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 150 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 300 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'BG001', 'title': 'Ocrelizumab 600 mg', 'description': 'Participants who weighed 40 kg or more were administered first dose of 600 mg ocrelizumab as two IV infusions given 14 days apart i. e. 2 x 300 mg on Days 1 and 15. Participants who completed the 24-week dose exploration period were eligible to continue ocrelizumab treatment in 264-week OOE period. Ocrelizumab 600 mg was administered as a single IV infusion given 24 weeks apart.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '1.8', 'groupId': 'BG001'}, {'value': '14.2', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cluster of Differentiation (CD) 19+B cells', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '287', 'groupId': 'BG000', 'lowerLimit': '160.0', 'upperLimit': '635.0'}, {'value': '234', 'groupId': 'BG001', 'lowerLimit': '73.0', 'upperLimit': '512.0'}, {'value': '246', 'groupId': 'BG002', 'lowerLimit': '73.0', 'upperLimit': '635.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/microliters (cells/µL)', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Number analyzed is the number of participants with data available for analysis.'}], 'populationDescription': 'Safety evaluable population included all participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-31', 'size': 2662971, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-16T07:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2019-08-14', 'resultsFirstSubmitDate': '2024-10-16', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-10-16', 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Exploration Period: Area Under the Concentration Versus Time Curve of Ocrelizumab', 'timeFrame': 'Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113', 'description': 'The population PK model was used to simulate concentration-time course and predict individual area under the concentration versus time curve. The data for the PK parameter: area under the concentration versus time curve was collected and analyzed as per body weight range (\\<40kg to ≥40 kg).'}, {'measure': 'Dose Exploration Period: Maximum Concentration (Cmax) of Ocrelizumab', 'timeFrame': 'Pre-dose 5- 30 minutes and post-dose 30 mins on Days 1, 15 and 169; At any time on Days 29, 57, 85 and 113', 'description': 'The population PK model was used to simulate concentration-time course and predict individual Cmax. The data for the PK parameter: Cmax was collected and analyzed as per body weight range (\\<40kg to ≥40 kg).'}, {'measure': 'Dose Exploration Period: Levels of CD 19+ B-cell Count in Blood', 'timeFrame': 'At Week 24'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 7 years', 'description': 'An AE is untoward medical occurrence in participant administered a pharmaceutical product \\& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \\& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.'}, {'measure': 'Dose Exploration Period: Level of Circulating T Cells and Natural Killer (NK) Cells', 'timeFrame': 'At Week 24'}, {'measure': 'OOE Period: Level of Circulating T Cells and NK Cells', 'timeFrame': 'Up to 5 years'}, {'measure': 'Dose Exploration Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte', 'timeFrame': 'At Week 24'}, {'measure': 'OOE Period: Level of Circulating Lymphocyte, Neutrophil, Monocyte and Leukocyte', 'timeFrame': 'Up to 5 years'}, {'measure': 'Developmental Milestones - Growth Velocity: Change in Height', 'timeFrame': 'Up to 7 years'}, {'measure': 'Developmental Milestones: Bone Age Assessment by Wrist/Hand Radiographs', 'timeFrame': 'Up to 7 years'}, {'measure': 'Developmental Milestones: Male and Female Puberty Assessed by Tanner Staging', 'timeFrame': 'Up to 7 years'}, {'measure': 'Developmental Milestones: Age at Menarche, Related With the Female Reproductive Status', 'timeFrame': 'Up to 7 years'}, {'measure': 'Dose Exploration Period: Number of Participants With Shift From Baseline in Non-MS Central Nervous System (CNS) Pathology as Measured by Brain Magnetic Resonance Imaging (MRI)', 'timeFrame': 'Up to Week 24', 'description': 'The change in the non-MS CNS pathology was assessed using MRI scans.'}, {'measure': 'OOE Period: Number of Participants With Shift From Baseline in Non-MS CNS Pathology as Measured by Brain MRI', 'timeFrame': 'Up to 5 years'}, {'measure': 'Dose Exploration Period: Levels of Blood Immunoglobulins', 'timeFrame': 'At Week 24'}, {'measure': 'OOE Period: Levels of Blood Immunoglobulins', 'timeFrame': 'Up to 5 years'}, {'measure': 'Dose Exploration Period: Number of Participants With Antibody Titers Against Standard Vaccines', 'timeFrame': 'At Week 24', 'description': 'Measurement of antibody titers to common antigens (mumps, rubella, varicella, and Streptococcus pneumoniae \\[S. pneumoniae\\]) were performed.'}, {'measure': 'OOE Period: Number of Participants With Antibody Titers Against Standard Vaccines', 'timeFrame': 'Up to 5 years'}, {'measure': 'Dose Exploration Period: Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab', 'timeFrame': 'At Week 24'}, {'measure': 'OOE Period: Number of Participants With ADAs to Ocrelizumab', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '39812825', 'type': 'DERIVED', 'citation': 'Mar S, Valeriani M, Steinborn B, Schreiner T, Waubant E, Filippi M, Kotulska K, Mazurkiewicz-Beldzinska M, El Azzouzi B, Lin CJ, Shen YA, Kletzl H, Evershed J, Hogea A, Manlius C, Bonati U, Banwell B. Ocrelizumab dose selection for treatment of pediatric relapsing-remitting multiple sclerosis: results of the OPERETTA I study. J Neurol. 2025 Jan 15;272(2):137. doi: 10.1007/s00415-024-12879-z.'}]}, 'descriptionModule': {'briefSummary': 'This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight \\>/= 25 kg\n* Children and adolescents must have received all childhood required vaccinations\n* Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception\n* Diagnosis of relapsing-remitting multiple sclerosis (RRMS)\n* Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive\n* Neurologic stability for \\>/= 30 days prior to screening, and between screening and baseline\n* Participants naive to prior disease-modifying therapy (DMT)\n* Participants who have had at least 6 contiguous months of DMT within the past 1 year must have evidence of disease activity occurring after the full 6-month course of treatment, that is, at least one relapse or \\>/= 1 Gd-enhancing lesion(s) on a T1-weighted brain MRI\n\nExclusion Criteria:\n\n* Known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development\n* Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG) antibody positive are not eligible to participate in the study.\n* In case of an ADEM-like appearance of the first MS attack, a second attack with clear MS-like features is required.\n* Infection requiring hospitalization or treatment with IV anti-infective agents\n* History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)\n* Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation\n* History or laboratory evidence of coagulation disorders\n* Peripheral venous access that precludes IV administration and venous blood sampling\n* Inability to complete a magnetic resonance imaging (MRI) scan\n* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ\n* History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution\n* Previous treatment with B-cell-targeted therapies\n* Percentage of CD4 \\< 30%\n* Absolute Neutrophil Count \\< 1.5x1000/microliter\n* Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range'}, 'identificationModule': {'nctId': 'NCT04075266', 'briefTitle': 'A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'WA39085'}, 'secondaryIdInfos': [{'id': '2016-002667-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants with a body weight from \\>/= 25 kg to \\< 40 kg (with at least 2 participants with a body weight from \\>/= 25 kg to \\</= 35 kg) will receive 300 milligram (mg) ocrelizumab', 'interventionNames': ['Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Participants with a body weight \\>/= 40 kg (with at least 2 participants with a body weight \\>/= 40 kg but \\</= 50 kg) will receive 600 mg ocrelizumab', 'interventionNames': ['Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 (optional)', 'description': 'Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight from \\>/= 25 kg to \\< 40 kg may be enrolled and receive another dose level of ocrelizumab', 'interventionNames': ['Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 (optional)', 'description': 'Based on PK, PD, safety, and tolerability data analyses of Cohorts 1 and 2, additional participants with a body weight \\>/= 40 kg may be enrolled and receive another dose level of ocrelizumab', 'interventionNames': ['Drug: Ocrelizumab']}], 'interventions': [{'name': 'Ocrelizumab', 'type': 'DRUG', 'description': 'Ocrelizumab is administered as two infusions of half the dose given 14 days apart for the first dose, then subsequent doses are administered as a single infusion every 24 weeks.\n\nCohort 1: total dose of 300 mg Cohort 2: total dose of 600 mg Cohort 3 and 4: additional dose level(s) may be lower than 300 mg, between 300 mg and 600 mg, or higher than 600 mg, but will be no higher than 1200 mg', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3 (optional)', 'Cohort 4 (optional)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver Childrens Hospital Rocky Mountain MS Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Health Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Childrens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington Universtiy school of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '00189', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': "Azienda Ospedaliera Sant'Andrea", 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '95123', 'city': 'Catania', 'state': 'Sicily', 'country': 'Italy', 'facility': 'AOU Policlinico V. Emanuele - P.O G. Rodolico', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '80-952', 'city': 'Gda?sk', 'country': 'Poland', 'facility': 'Uniwersyteckie Centrum Kliniczne'}, {'zip': '60-355', 'city': 'Późna', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Poznaniu', 'geoPoint': {'lat': 51.84442, 'lon': 14.61868}}, {'zip': '02-091', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-730', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Instytut Pomnik Centrum Zdrowia Dziecka', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}