Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00673920
Status:
TERMINATED
Last Update Posted:
2020-12-04
First Post:
2008-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C533411', 'term': 'ocrelizumab'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'From baseline up to 17 months', 'description': 'Re-randomized Safety Population: All patients (including those not re-randomized at Week 24) who received any part of the second course and provided at least one assessment of safety prior to Week 48 were included in the Re-randomized Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 32, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 59, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Ocrelizumab 200mg', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 80, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 46, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 49, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 86, 'seriousNumAtRisk': 109, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 20, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 22, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'INFUSION RELATED REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 2, 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5}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'MYCOBACTERIUM ABSCESSUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 12.1'}, {'term': 'COLITIS ULCERATIVE', 'stats': 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'44.1', 'upperLimit': '61.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \\[VAS\\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '5.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \\[0.56 × square root of TJC\\] + \\[0.28 × square root of SJC\\] + \\[0.70 × natural log (ESR)\\] + \\[0.014 × VAS\\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change in DAS28 From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.79', 'spread': '1.293', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '1.374', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '1.320', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \\[0.56 × square root of TJC\\] + \\[0.28 × square root of SJC\\] + \\[0.70 × natural log (ESR)\\] + \\[0.014 × VAS\\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity. The change is the difference in adjusted mean change from baseline in DAS28 between ocrelizumab 400 x 1 and ocrelizumab 200 x 2 with placebo.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'title': 'Week 4 No Response', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '62.4', 'groupId': 'OG001'}, {'value': '58.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 Moderate Response', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 Good Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 No Response', 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000'}, {'value': '52.1', 'groupId': 'OG001'}, {'value': '48.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 Moderate Response', 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}, {'value': '42.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 Good Response', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 No Response', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '41.9', 'groupId': 'OG001'}, {'value': '35.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 Moderate Response', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '49.6', 'groupId': 'OG001'}, {'value': '54.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 Good Response', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '9.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 No Response', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}, {'value': '35.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 Moderate Response', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '49.6', 'groupId': 'OG001'}, {'value': '47.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 Good Response', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 No Response', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '41.0', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 Moderate Response', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '48.7', 'groupId': 'OG001'}, {'value': '51.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 Good Response', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '18.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 No Response', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 Moderate Response', 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '41.0', 'groupId': 'OG001'}, {'value': '47.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 Good Response', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '14.5', 'groupId': 'OG001'}, {'value': '13.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ACR50 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The ACR50 response at any time was defined as \\>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ACR70 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '7.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The ACR70 response at any time was defined as \\>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Individual Parameters of the ACR Core Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'title': 'SJC', 'categories': [{'measurements': [{'value': '-4.6', 'groupId': 'OG000'}, {'value': '-7.5', 'groupId': 'OG001'}, {'value': '-8.7', 'groupId': 'OG002'}]}]}, {'title': 'TJC', 'categories': [{'measurements': [{'value': '-8.2', 'groupId': 'OG000'}, {'value': '-10.2', 'groupId': 'OG001'}, {'value': '-12.0', 'groupId': 'OG002'}]}]}, {'title': "Patient's global assessment", 'categories': [{'measurements': [{'value': '-7.6', 'groupId': 'OG000'}, {'value': '-21.2', 'groupId': 'OG001'}, {'value': '-24.3', 'groupId': 'OG002'}]}]}, {'title': "Physician's global assessment", 'categories': [{'measurements': [{'value': '-16.0', 'groupId': 'OG000'}, {'value': '-24.3', 'groupId': 'OG001'}, {'value': '-26.0', 'groupId': 'OG002'}]}]}, {'title': "Patient's pain assessment", 'categories': [{'measurements': [{'value': '-8.0', 'groupId': 'OG000'}, {'value': '-17.2', 'groupId': 'OG001'}, {'value': '-21.0', 'groupId': 'OG002'}]}]}, {'title': 'HAQ-DI', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}, {'value': '-0.4', 'groupId': 'OG001'}, {'value': '-0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Change in the scores of the following parameters of ACR core set relative to respective baseline scores was measured: SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS \\[0 = no disease activity to 100 = maximum disease activity\\]), HAQ (based on HAQ disability index \\[HAQDI\\]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain).", 'unitOfMeasure': 'Units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}, {'value': '-1.0', 'groupId': 'OG001'}, {'value': '-0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'mg/dL', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000'}, {'value': '-14.2', 'groupId': 'OG001'}, {'value': '-11.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'mm/hr', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '49.4'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '46.6', 'upperLimit': '64.6'}, {'value': '58.8', 'groupId': 'OG002', 'lowerLimit': '50.3', 'upperLimit': '67.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change in SF-36 Subscale and Summary Scores From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'title': 'Mental Component Summary Category Improved', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}, {'value': '36.6', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Summary Category Unchanged', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '51.2', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Summary Category Worsened', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '15.1', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Improved', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}, {'value': '45.3', 'groupId': 'OG001'}, {'value': '53.7', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Unchanged', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Worsened', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Improved, change \\> 5.42; Unchanged, -5.42 \\<= Change \\<= 5.42; Worsened, change \\< -5.42', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Change in FACIT-F Fatigue Assessment From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '25.13', 'spread': '10.616', 'groupId': 'OG000'}, {'value': '25.33', 'spread': '11.313', 'groupId': 'OG001'}, {'value': '24.74', 'spread': '11.161', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '28.94', 'spread': '11.371', 'groupId': 'OG000'}, {'value': '28.60', 'spread': '11.231', 'groupId': 'OG001'}, {'value': '30.71', 'spread': '11.136', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '28.42', 'spread': '12.015', 'groupId': 'OG000'}, {'value': '32.09', 'spread': '12.368', 'groupId': 'OG001'}, {'value': '33.09', 'spread': '10.903', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '28.47', 'spread': '12.406', 'groupId': 'OG000'}, {'value': '31.38', 'spread': '11.346', 'groupId': 'OG001'}, {'value': '33.18', 'spread': '11.011', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 12, and 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population (original randomization)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ACR20 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG003'}, {'value': '54.1', 'groupId': 'OG004'}, {'value': '56.9', 'groupId': 'OG005'}, {'value': '44.8', 'groupId': 'OG006'}, {'value': '42.9', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \\[VAS\\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study extension period included all participants who were re-randomized at Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ACR50 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG003'}, {'value': '27.9', 'groupId': 'OG004'}, {'value': '34.9', 'groupId': 'OG005'}, {'value': '20.7', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The ACR50 response at any time was defined as \\>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study extension period included all participants who were re-randomized at Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ACR70 Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG003'}, {'value': '16.4', 'groupId': 'OG004'}, {'value': '19.3', 'groupId': 'OG005'}, {'value': '6.9', 'groupId': 'OG006'}, {'value': '7.1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': "The ACR70 response at any time was defined as \\>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study extension period included all participants who were re-randomized at Week 24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '109', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'OG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG002', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'OG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG003'}, {'value': '3.3', 'groupId': 'OG004'}, {'value': '11.0', 'groupId': 'OG005'}, {'value': '6.9', 'groupId': 'OG006'}, {'value': '3.6', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study extension period included all participants who were re-randomized at Week 24.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '183', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG001', 'title': 'Ocrelizumab 200mg - Cycle 2', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate in Cycle 2'}, {'id': 'OG002', 'title': 'Ocrelizumab 400mg - Cycle 1', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'OG003', 'title': 'Ocrelizumab 400mg - Cycle 2', 'description': 'Participants who received a single infusion of 400 mg Ocrelizumab + Methotraxate in Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'spread': '63.8', 'groupId': 'OG000'}, {'value': '67.7', 'spread': '27.0', 'groupId': 'OG001'}, {'value': '133', 'spread': '38.5', 'groupId': 'OG002'}, {'value': '137', 'spread': '45.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24, 48', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Placebo population was excluded from the analysis.'}, {'type': 'SECONDARY', 'title': 'Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab 200mg - Cycle 1', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'OG001', 'title': 'Ocrelizumab 200mg - Cycle 2', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate in Cycle 2'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '77.6', 'spread': '27.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 of Cycles 1 and 2', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all participants who received second Ocrelizumab infusion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'FG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'FG002', 'title': 'Ocrelizumab 200mg', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'FG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'FG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'FG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'FG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'FG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}], 'periods': [{'title': 'Baseline up to Week 48', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '117'}, {'groupId': 'FG002', 'numSubjects': '133'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '126'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Violation of selection criteria at entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse event/intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Week 24 to Week 48', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '61'}, {'groupId': 'FG005', 'numSubjects': '109'}, {'groupId': 'FG006', 'numSubjects': '29'}, {'groupId': 'FG007', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '61'}, {'groupId': 'FG005', 'numSubjects': '106'}, {'groupId': 'FG006', 'numSubjects': '28'}, {'groupId': 'FG007', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse event/intercurrent illness', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adminstrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Screening was completed within 28 days prior to randomization. This may have been extended by an additional 56 days, up to a maximum of 84 days, if washout from the respective disease modifying anti-rheumatic drugs (DMARDs) or if immunization was required.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '312', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)'}, {'id': 'BG001', 'title': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.'}, {'id': 'BG002', 'title': 'Ocrelizumab 200mg', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.'}, {'id': 'BG003', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'BG004', 'title': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'BG005', 'title': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'BG006', 'title': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'BG007', 'title': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '11.45', 'groupId': 'BG000'}, {'value': '52.3', 'spread': '11.14', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '11.15', 'groupId': 'BG002'}, {'value': '52.8', 'spread': '11.2', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics not provided for Participants who were re-randomized at Week 24 (Cycle 2)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 314}}, 'statusModule': {'whyStopped': 'Based on analysis of results and consideration of available treatments, the overall benefit to risk profile of ocrelizumab was not favorable in RA.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2013-06-28', 'completionDateStruct': {'date': '2009-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2008-05-05', 'dispFirstSubmitQcDate': '2013-06-28', 'resultsFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2008-05-05', 'dispFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-10', 'studyFirstPostDateStruct': {'date': '2008-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With American College of Rheumatology (ACR) 20 Response', 'timeFrame': 'Week 24', 'description': "ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \\[VAS\\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Remission (DAS28 < 2.6)', 'timeFrame': 'Week 24', 'description': "The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \\[0.56 × square root of TJC\\] + \\[0.28 × square root of SJC\\] + \\[0.70 × natural log (ESR)\\] + \\[0.014 × VAS\\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity."}, {'measure': 'Change in DAS28 From Baseline', 'timeFrame': 'Week 24', 'description': "The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \\[0.56 × square root of TJC\\] + \\[0.28 × square root of SJC\\] + \\[0.70 × natural log (ESR)\\] + \\[0.014 × VAS\\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity. The change is the difference in adjusted mean change from baseline in DAS28 between ocrelizumab 400 x 1 and ocrelizumab 200 x 2 with placebo."}, {'measure': 'European League Against Rheumatism (EULAR) Response Rates (Categorical DAS Responders)', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of Participants Achieving an ACR50 Response', 'timeFrame': 'Week 24', 'description': "The ACR50 response at any time was defined as \\>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL)."}, {'measure': 'Percentage of Participants Achieving an ACR70 Response', 'timeFrame': 'Week 24', 'description': "The ACR70 response at any time was defined as \\>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL)."}, {'measure': 'Change From Baseline in the Individual Parameters of the ACR Core Set', 'timeFrame': 'Week 24', 'description': "Change in the scores of the following parameters of ACR core set relative to respective baseline scores was measured: SJC (28 and 66 joints) and TJC (28 and 66 joints), patient's global assessment and physician's global assessment based on disease activity (both are expressed by VAS \\[0 = no disease activity to 100 = maximum disease activity\\]), HAQ (based on HAQ disability index \\[HAQDI\\]) which included 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities) rated on a 4-point scale (0=without any difficulty to 3=unable to do), where the sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst), pain assessment using a VAS ranging from score 0 (no pain) to 100 (unbearable pain)."}, {'measure': 'Change From Baseline in the Individual Parameters of the ACR Core Set: C-Reactive Protein (CRP) Concentration', 'timeFrame': 'Week 24'}, {'measure': 'Change From Baseline in the Individual Parameters of the ACR Core Set: Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of Participants With a Reduction of Greater Than or Equal to 0.25 Units in the HAQ-DI Score', 'timeFrame': 'Week 24'}, {'measure': 'Change in SF-36 Subscale and Summary Scores From Baseline', 'timeFrame': 'Week 24', 'description': 'Improved, change \\> 5.42; Unchanged, -5.42 \\<= Change \\<= 5.42; Worsened, change \\< -5.42'}, {'measure': 'Change in FACIT-F Fatigue Assessment From Baseline', 'timeFrame': 'Baseline, Weeks 4, 12, and 24', 'description': "The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline."}, {'measure': 'Percentage of Participants Achieving an ACR20 Response', 'timeFrame': 'Week 48', 'description': "ACR20 response: greater than or equal to (≥) 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) participant assessment of disease activity, 3) Patient Assessment of Pain (visual analog scale \\[VAS\\]), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) erythrocyte sedimentation rate (ESR) at each visit."}, {'measure': 'Percentage of Participants Achieving an ACR50 Response', 'timeFrame': 'Week 48', 'description': "The ACR50 response at any time was defined as \\>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL)."}, {'measure': 'Percentage of Participants Achieving an ACR70 Response', 'timeFrame': 'Week 48', 'description': "The ACR70 response at any time was defined as \\>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL)."}, {'measure': 'Percentage of Participants Achieving DAS28 Remission (DAS28 < 2.6)', 'timeFrame': 'Week 48'}, {'measure': 'Cmax: Maximum Observed Serum Concentration of Ocrelizumab Following First Infusion', 'timeFrame': 'Week 24, 48'}, {'measure': 'Csecond: Maximum Observed Serum Concentration of Ocrelizumab Following Second Infusion', 'timeFrame': 'Day 15 of Cycles 1 and 2'}]}, 'conditionsModule': {'keywords': ['RA'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24498318', 'type': 'DERIVED', 'citation': 'Emery P, Rigby W, Tak PP, Dorner T, Olech E, Martin C, Millar L, Travers H, Fisheleva E. Safety with ocrelizumab in rheumatoid arthritis: results from the ocrelizumab phase III program. PLoS One. 2014 Feb 3;9(2):e87379. doi: 10.1371/journal.pone.0087379. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of ocrelizumab, compared to placebo, in patients with active rheumatoid arthritis who have an inadequate response to methotrexate therapy. Patients will be randomized 2:2:1 to receive 1) infusions of ocrelizumab 200mg iv on Days 1 and 15, 2) infusions of ocrelizumab 400mg iv on Day 1 and placebo iv on Day 15, or 3) infusions of placebo iv on Days 1 and 15. At the end of the placebo-controlled treatment period at 24 weeks, patients in groups 1 and 3 will be re-randomized to receive either a single infusion of 400mg iv ocrelizumab or 2 infusions of 200mg iv ocrelizumab, and group 2 will receive a second single infusion of 400mg iv ocrelizumab. All patients will receive a stable dose of concomitant methotrexate (7.5-25mg/week) throughout the study. The anticipated time on study treatment is 1-2 years. Target number of patients to be enrolled in this trial is 300.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients, ≥ 18 years of age\n* Active rheumatoid arthritis\n* Inadequate treatment with any DMARD other than methotrexate\n\nExclusion criteria:\n\n* Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis\n* Concurrent treatment with any DMARD other than methotrexate\n* Previous treatment with any cell-depleting therapies\n* Any surgical procedure in past 12 weeks, or planned within 48 weeks after baseline'}, 'identificationModule': {'nctId': 'NCT00673920', 'acronym': 'FEATURE', 'briefTitle': 'A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy', 'orgStudyIdInfo': {'id': 'ACT4394g'}, 'secondaryIdInfos': [{'id': 'WA20496'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo:\n\n* on Day 15 of Cycle 1 (Participants who were administered OCR 400 mg on Day 1 of a Cycle 1 in combination with Methotrexate)\n* on both Days 1 and Day 15 of Cycle 1 (Participants who were randomized to the Placebo + Methotrexate group)', 'interventionNames': ['Drug: Methotrexate', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab 400mg', 'description': 'Participants received Ocrelizumab 400mg in combination with Methotrexate on Day 1, Cycle 1.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab 200mg', 'description': 'Participants received Ocrelizumab 200 mg in combination with Methotrexate on Day 1 and Day 15, Cycle 1.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'description': 'Participants who received two 200 mg infusions of Ocrelizumab + Methotraxate during Cycle 1 were re-randomized (1:1 randomization ratio) to receive a single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'description': 'Participants who received single 400mg infusions of Ocrelizumab + Methotraxate during Cycle 1 received a infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/ Ocrelizumab 200mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive two infusions of 200 mg Ocrelizumab + Methotraxate during Cycle 2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/ Ocrelizumab 400mg', 'description': 'Participants who received placebo during Cycle 1 were re-randomized (1:1 randomization ratio) to receive single infusion of 400 mg Ocrelizumab + Methotraxate during Cycle 2', 'interventionNames': ['Drug: Methotrexate', 'Drug: Ocrelizumab', 'Drug: Placebo']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Oral or parenteral repeating dose', 'armGroupLabels': ['Ocrelizumab 200mg', 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'Ocrelizumab 400mg', 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'Placebo', 'Placebo/ Ocrelizumab 200mg', 'Placebo/ Ocrelizumab 400mg']}, {'name': 'Ocrelizumab', 'type': 'DRUG', 'description': 'Ocrelizumab was administered as a slow intravenous (iv) infusion during each course as either 200 mg on Day 1 and Day 15 (OCR 200×2) or as 400 mg given on Day 1 (OCR 400×1).\n\nOcrelizumab was administered in combination with Methotrexate.', 'armGroupLabels': ['Ocrelizumab 200mg', 'Ocrelizumab 200mg/ Ocrelizumab 200mg', 'Ocrelizumab 200mg/ Ocrelizumab 400mg', 'Ocrelizumab 400mg', 'Ocrelizumab 400mg/ Ocrelizumab 400mg', 'Placebo/ Ocrelizumab 200mg', 'Placebo/ Ocrelizumab 400mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['Placebo', 'Placebo/ Ocrelizumab 200mg', 'Placebo/ Ocrelizumab 400mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wolfgang Dummer, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}