Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00299104
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2006-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
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': 'D005492', 'term': 'Folic Acid'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, '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 to End of ESFU', 'description': 'Safety Population includes all participants who received at least one dose of study drug, grouped as treated. After Week 104 participants in the placebo group were eligible to receive either Rituximab 2 X 0.5 g + MTX or Rituximab 2 X 1.0g + MTX. Adverse events reported for placebo patients after switching to Rituximab are not included below.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.', 'otherNumAtRisk': 249, 'otherNumAffected': 193, 'seriousNumAtRisk': 249, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6', 'otherNumAtRisk': 348, 'otherNumAffected': 232, 'seriousNumAtRisk': 348, 'seriousNumAffected': 54}, {'id': 'EG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6', 'otherNumAtRisk': 263, 'otherNumAffected': 208, 'seriousNumAtRisk': 263, 'seriousNumAffected': 58}], 'otherEvents': [{'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 67}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drug-Induced Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 38}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumocystis Jirovecii Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia Pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis Perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diverticular Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal Hypomotility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Inguinal Hernia, Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carotid Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Embolic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carcinoma In Situ of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cervix Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myelodysplastic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Primary 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 249, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 263, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '1.079', 'spread': '4.0934', 'groupId': 'OG000'}, {'value': '0.646', 'spread': '1.9196', 'groupId': 'OG001'}, {'value': '0.359', 'spread': '1.0095', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons.', 'groupDescription': 'Comparing all three treatment groups', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1824', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons.', 'groupDescription': 'Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons.', 'groupDescription': 'Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Sharp Erosion Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.738', 'spread': '2.0480', 'groupId': 'OG000'}, {'value': '0.453', 'spread': '1.2065', 'groupId': 'OG001'}, {'value': '0.233', 'spread': '0.6252', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Comparing all three treatment groups', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1194', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 0.5 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 1.0 g + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Without Radiographic Progression at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}, {'value': '63.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3803', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.13', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.18', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \\<= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Patients with missing data are classified as progressing.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '59.0', 'groupId': 'OG001'}, {'value': '66.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3752', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0081', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab (1.0 g x 2) + Methotrexate verus Placebo + Methotrexate, stratified for region and Baseline RF status.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.341', 'spread': '2.2408', 'groupId': 'OG000'}, {'value': '0.193', 'spread': '0.9422', 'groupId': 'OG001'}, {'value': '0.126', 'spread': '0.6363', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5939', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Comparing all three treatment groups.', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5478', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3096', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The Closure Principle was used to adjust for multiple comparisons. This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat population includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized. Linear interpolation/extrapolation used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Modified Total Sharp Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.701', 'spread': '2.9116', 'groupId': 'OG000'}, {'value': '0.508', 'spread': '1.7349', 'groupId': 'OG001'}, {'value': '0.328', 'spread': '0.9443', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time point for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Erosion Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.491', 'spread': '1.3789', 'groupId': 'OG000'}, {'value': '0.404', 'spread': '1.0390', 'groupId': 'OG001'}, {'value': '0.220', 'spread': '0.5802', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) who had data available at Week 24 for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '0.210', 'spread': '1.7403', 'groupId': 'OG000'}, {'value': '0.176', 'spread': '0.8949', 'groupId': 'OG001'}, {'value': '0.108', 'spread': '0.6118', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the modified intent-to-treat population (includes patients with a screening and at least one post-baseline radiographic evaluation, grouped as randomized) with data available at Week 24 for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Radiographic Progression at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}, {'value': '71.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '59.4', 'groupId': 'OG001'}, {'value': '64.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Rituximab 2 x 1.0 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline RF status', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.33', 'spread': '1.691', 'groupId': 'OG000'}, {'value': '-3.35', 'spread': '1.663', 'groupId': 'OG001'}, {'value': '-3.46', 'spread': '1.640', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "DAS28-ESR is calculated from the following formula:\n\n(0.56 \\* TJC) + (0.28 \\* SJC) + (0.70 \\* ln ESR) + (0.014 \\* GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR \\< 2.6).", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000'}, {'value': '42.2', 'groupId': 'OG001'}, {'value': '46.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-ESR Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.\n\nRemission is defined as achieving a DAS28-ESR score of less than 2.6", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '41.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of \\> 1.2 compared with baseline, and attainment of a DAS28-ESR of \\< 3.2.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing'}, {'type': 'SECONDARY', 'title': 'The Percentage of Participants With Major Clinical Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Major clinical response is defined as a continuous six-month period of success by the ACR70.\n\nACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000'}, {'value': '40.3', 'groupId': 'OG001'}, {'value': '43.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.\n\nLow disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '80.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Patients are considered non-responders if data are missing or from the point of withdrawal, rescue use or receipt of non-permitted Disease-modifying anti-rheumatic drugs (DMARDs).'}, {'type': 'SECONDARY', 'title': 'Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '10.154', 'spread': '11.1344', 'groupId': 'OG000'}, {'value': '11.833', 'spread': '11.5807', 'groupId': 'OG001'}, {'value': '12.426', 'spread': '12.2535', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's 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 patient'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). A higher score reflects an improvement in the patient's health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent to treat (ITT) population includes all randomized participants who received at least one infusion who had data available for analyses. Observed data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.800', 'spread': '0.7764', 'groupId': 'OG000'}, {'value': '-1.038', 'spread': '0.7625', 'groupId': 'OG001'}, {'value': '-1.023', 'spread': '0.7634', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Secondary endpoint in hierarchical testing structure.', 'groupDescription': 'Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate stratified for region and RF status.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Secondary endpoint in hierarchical testing structure.', 'groupDescription': 'Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to treat Population includes all randomized participants who received at least one dose of study drug. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'title': 'Week 52 (n=239,236,241)', 'categories': [{'measurements': [{'value': '8.953', 'spread': '9.3986', 'groupId': 'OG000'}, {'value': '11.022', 'spread': '9.6246', 'groupId': 'OG001', 'lowerLimit': '-0.331', 'upperLimit': '3.504'}, {'value': '12.205', 'spread': '9.4986', 'groupId': 'OG002', 'lowerLimit': '1.214', 'upperLimit': '5.026'}]}]}, {'title': 'Week 104 (n=240,236,242)', 'categories': [{'measurements': [{'value': '8.617', 'spread': '9.8500', 'groupId': 'OG000'}, {'value': '11.032', 'spread': '9.9631', 'groupId': 'OG001', 'lowerLimit': '1.590', 'upperLimit': '4.787'}, {'value': '12.649', 'spread': '10.4331', 'groupId': 'OG002', 'lowerLimit': '2.749', 'upperLimit': '5.920'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.\n\nMeans are adjusted for baseline value, Rheumatoid Factor status and region.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all participants who received at least one infusion. Last observation carried forward. "n" in each of the categories is the number of participants with data available for analyses at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'title': 'Week 52 (n=239,236,241)', 'categories': [{'measurements': [{'value': '6.689', 'spread': '13.1160', 'groupId': 'OG000'}, {'value': '7.718', 'spread': '11.8903', 'groupId': 'OG001'}, {'value': '8.167', 'spread': '12.1709', 'groupId': 'OG002'}]}]}, {'title': 'Week 104 (n= 240,236,242)', 'categories': [{'measurements': [{'value': '6.295', 'spread': '13.9813', 'groupId': 'OG000'}, {'value': '7.617', 'spread': '12.0793', 'groupId': 'OG001'}, {'value': '9.066', 'spread': '12.5325', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 52, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.\n\nMeans are adjusted for baseline value, Rheumatoid Factor status and region.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward. "n" in each of the categories is the number of participants with data available for analyses at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}, {'value': '86.8', 'groupId': 'OG002'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Not Assessable', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.\n\nImproved:HAQ-DI score change \\<=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score =\\> 0.22', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population includes all randomized participants who received at least one infusion. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '69.9', 'groupId': 'OG001'}, {'value': '76.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'MCID is defined as a change from baseline in SF-36 Physical Health Component Score of \\>5.42.\n\nSF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '50.8', 'groupId': 'OG001'}, {'value': '57.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 52', 'description': 'MCID is defined as a change from baseline in SF-36 Mental Health Component Score of \\>6.33.\n\nSF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population, includes all randomized participants who received at least one dose of study drug, with data available for analysis at Baseline and Week 52. Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Modified Total Sharp Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '1.948', 'spread': '5.5782', 'groupId': 'OG000'}, {'value': '0.761', 'spread': '2.6181', 'groupId': 'OG001'}, {'value': '0.406', 'spread': '1.4312', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This was a secondary endpoint in a hierarchical testing structure.', 'groupDescription': 'Week 104: Rituximab 2 x 0.5 g + Methotrexate arm versus Placebo + Methotrexate, stratified for region and baseline rheumatoid factor (RF) status.', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments at the given time-point for analysis. Linear extrapolation was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Erosion Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '1.315', 'spread': '3.2466', 'groupId': 'OG000'}, {'value': '0.499', 'spread': '1.7221', 'groupId': 'OG001'}, {'value': '0.227', 'spread': '0.7939', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and who had both screening and post-baseline radiographic assessments at the given time point for analyses. Linear extrapolation used for missing data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Radiographic Progression at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000'}, {'value': '49.4', 'groupId': 'OG001'}, {'value': '56.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 104', 'description': 'Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '244', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}, {'value': '58.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 104', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.\n\nNo progression is defined as a change from score at screening to week 104 ≤0.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Modified Intent to Treat (MITT) population includes all randomized participants who received at least one infusion and had both screening and post-baseline radiographic assessments. Patients with missing data are classified as progressing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'OG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'OG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.806', 'spread': '0.7968', 'groupId': 'OG000'}, {'value': '-1038', 'spread': '0.8142', 'groupId': 'OG001'}, {'value': '-1.055', 'spread': '0.7901', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Secondary endpoint in hierarchical testing structure.', 'groupDescription': 'Rituximab (0.5 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Secondary endpoint in hierarchical testing structure.', 'groupDescription': 'Rituximab (1.0 g x 2) + Methotrexate versus Placebo + Methotrexate, stratified for region and baseline RF status.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 104', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to treat Population includes all randomized participants who received at least one dose of study drug with data at baseline and Week 104 available for analysis. Last observation carried forward.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'FG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'FG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '252'}, {'groupId': 'FG002', 'numSubjects': '252'}]}, {'type': 'Safety/ITT: Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '249'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'Completed Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '241'}]}, {'type': 'Completed Week 52', 'achievements': [{'groupId': 'FG000', 'numSubjects': '213'}, {'groupId': 'FG001', 'numSubjects': '227'}, {'groupId': 'FG002', 'numSubjects': '232'}]}, {'type': 'Completed Week 104', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '216'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Week 152', 'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '175'}, {'groupId': 'FG002', 'numSubjects': '172'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Insufficient therapeutic response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Failure to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Violation of selection criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Refused treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '137'}]}]}, {'title': 'Safety Follow-Up (SFU) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants who received treatment were to enter SFU even if withdrawn during treatment period.', 'groupId': 'FG000', 'numSubjects': '184'}, {'comment': 'All participants who received treatment were to enter SFU even if withdrawn during treatment period.', 'groupId': 'FG001', 'numSubjects': '212'}, {'comment': 'All participants who received treatment were to enter SFU even if withdrawn during treatment period.', 'groupId': 'FG002', 'numSubjects': '213'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '171'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}, {'title': 'Extended Safety Follow-Up (ESFU) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.', 'groupId': 'FG000', 'numSubjects': '34'}, {'comment': 'Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.', 'groupId': 'FG001', 'numSubjects': '40'}, {'comment': 'Only participants with CD19+ B-cell counts below baseline level or less than 80 cells/microliter.', 'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '748', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.'}, {'id': 'BG001', 'title': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'BG002', 'title': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nSubsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.06', 'spread': '12.692', 'groupId': 'BG000'}, {'value': '47.87', 'spread': '13.391', 'groupId': 'BG001'}, {'value': '47.89', 'spread': '13.324', 'groupId': 'BG002'}, {'value': '47.94', 'spread': '13.136', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Intent-to-treat population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '607', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intent-to-treat population', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 755}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-29', 'studyFirstSubmitDate': '2006-03-02', 'resultsFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2006-03-03', 'lastUpdatePostDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-13', 'studyFirstPostDateStruct': {'date': '2006-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in Total Modified Sharp Score (TMSS) from screening to Week 52 in the modified intent-to-treat (MITT) population. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Modified Sharp Erosion Score at Week 52', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in modified Sharp erosion score from screening to Week 52. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions.'}, {'measure': 'Percentage of Patients Without Radiographic Progression at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Percentage of patients without radiographic progression at Week 52, defined as change in total modified Sharp score (TMSS) \\<= 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.'}, {'measure': 'Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'No radiographic progression is defined as a change in the total erosion score at Week 52 of less than or equal to zero.'}, {'measure': 'Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52', 'timeFrame': 'Baseline and week 52', 'description': 'Rate of progression in structural joint damage (PJD) by change in modified joint space narrowing (JSN) from screening to Week 52. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.'}, {'measure': 'Change From Baseline in the Modified Total Sharp Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.'}, {'measure': 'Change From Baseline in the Total Erosion Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The Total Erosion Score at Week 24 - Total Erosion Score at baseline is calculated.'}, {'measure': 'Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Joint Space Narrowing is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.'}, {'measure': 'Percentage of Participants Without Radiographic Progression at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'Percentage of patients without radiographic progression at Week 24 defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.'}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52', 'timeFrame': 'Week 52', 'description': "To achieve an ACR50 response requires at least a 50% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 50% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"}, {'measure': 'Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "DAS28-ESR is calculated from the following formula:\n\n(0.56 \\* TJC) + (0.28 \\* SJC) + (0.70 \\* ln ESR) + (0.014 \\* GH) TJC = tender joint count, based on 28 joints SJC = swollen joint count, based on 28 joints ESR = erythrocyte sedimentation rate in mm/h GH = patient's global assessment of disease activity A DAS28-ESR score of 5.1 or above is considered to indicate high disease activity. Patients can also be defined as having low disease activity (DAS28-ESR ≤ 3.2) or remission (DAS28-ESR \\< 2.6)."}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR70 response requires at least a 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"}, {'measure': 'Percentage of Participants With DAS28-ESR Remission at Week 52', 'timeFrame': 'Week 52', 'description': "The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.\n\nRemission is defined as achieving a DAS28-ESR score of less than 2.6"}, {'measure': 'Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'European League Against Rheumatism (EULAR) criteria reflects an improvement in disease activity and an attainment of a lower degree of disease activity. A good response is defined as an improvement in the DAS28-ESR of \\> 1.2 compared with baseline, and attainment of a DAS28-ESR of \\< 3.2.'}, {'measure': 'The Percentage of Participants With Major Clinical Response at Week 52', 'timeFrame': 'Week 52', 'description': "Major clinical response is defined as a continuous six-month period of success by the ACR70.\n\nACR70= 70% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 70% improvement in 3 of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"}, {'measure': 'Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52', 'timeFrame': 'Week 52', 'description': "The DAS28-4(ESR) score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10.\n\nLow disease activity is defined as achieving a DAS28-ESR score of less than or equal to 3.2"}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR20 response requires at least a 20% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 20% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "To achieve an ACR90 response requires at least a 90% improvement compared with baseline in both Total Joint Count and Swollen Joint Count, as well as a 90% improvement in three of five additional measurements from:\n\n* the physician's global assessment of disease activity\n* patient's global assessment of disease activity\n* patient's assessment of pain\n* HAQ-DI (Health Assessment Questionnaire disability index)\n* an acute phase reactant C-Reactive Protein (CRP). (If CRP was missing then Erythrocyte Sedimentation Rate (ESR) was used if available.)"}, {'measure': 'Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's 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 patient'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). A higher score reflects an improvement in the patient's health status."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip,and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104', 'timeFrame': 'Baseline, Week 52, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.\n\nMeans are adjusted for baseline value, Rheumatoid Factor status and region.'}, {'measure': 'Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104', 'timeFrame': 'Baseline, Weeks 52, Week 104', 'description': 'The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.\n\nMeans are adjusted for baseline value, Rheumatoid Factor status and region.'}, {'measure': 'Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least two component questions. There are four possible responses for each component on a scale of 0 (without difficulty) to 3 (unable to do). Higher scores=greater dysfunction.\n\nImproved:HAQ-DI score change \\<=-0.22 Unchanged:HAQ-DI score change -0.22 to 0.22 Worsened:HAQ score =\\> 0.22'}, {'measure': 'Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'MCID is defined as a change from baseline in SF-36 Physical Health Component Score of \\>5.42.\n\nSF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.'}, {'measure': 'Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'MCID is defined as a change from baseline in SF-36 Mental Health Component Score of \\>6.33.\n\nSF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Modified Total Sharp Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The modified total sharp score is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change and higher scores represent a worsening of joint erosions and joint space narrowing.'}, {'measure': 'Change From Baseline in the Total Erosion Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The change from the score at baseline to week 104 is calculated.'}, {'measure': 'Percentage of Participants Without Radiographic Progression at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'Percentage of patients without radiographic progression at Week 104, defined as change in total modified Sharp score (TMSS) ≤ 0. TMSS is the sum of the erosion score (ES) and the joint space narrowing (JSN) score and has a range of 0 to 398. The ES is the sum of joint scores collected for 46 joints and has a range of 0 to 230. The JSN is the sum of joint scores collected for 42 joints and has a range of 0 to 168. A score of 0 would indicate no change.'}, {'measure': 'Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104', 'timeFrame': 'Week 104', 'description': 'Total Erosion Score is determined by evaluation of fourteen sites in each wrist and hand and six joints in each foot using an eight-point scale from 0 (normal: no erosions) to 3.5 (Very severe; erosions of 100% of the articular surfaces. The score at baseline is compared to the score at week 104.\n\nNo progression is defined as a change from score at screening to week 104 ≤0.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104', 'timeFrame': 'Baseline, Week 104', 'description': 'The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0(without any difficulty) to 4 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered. A negative change from baseline indicates improvement.'}]}, 'conditionsModule': {'keywords': ['Rituxan', 'MTX', 'RA', 'IMAGE', 'WA17047'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '22012969', 'type': 'DERIVED', 'citation': 'Tak PP, Rigby W, Rubbert-Roth A, Peterfy C, van Vollenhoven RF, Stohl W, Healy E, Hessey E, Reynard M, Shaw T. Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE. Ann Rheum Dis. 2012 Mar;71(3):351-7. doi: 10.1136/annrheumdis-2011-200170. Epub 2011 Oct 19.'}, {'pmid': '21557525', 'type': 'DERIVED', 'citation': 'Rigby W, Ferraccioli G, Greenwald M, Zazueta-Montiel B, Fleischmann R, Wassenberg S, Ogale S, Armstrong G, Jahreis A, Burke L, Mela C, Chen A. Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate. Arthritis Care Res (Hoboken). 2011 May;63(5):711-20. doi: 10.1002/acr.20419.'}, {'pmid': '20937671', 'type': 'DERIVED', 'citation': 'Tak PP, Rigby WF, Rubbert-Roth A, Peterfy CG, van Vollenhoven RF, Stohl W, Hessey E, Chen A, Tyrrell H, Shaw TM; IMAGE Investigators. Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial. Ann Rheum Dis. 2011 Jan;70(1):39-46. doi: 10.1136/ard.2010.137703. Epub 2010 Oct 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adult patients 18-80 years of age\n* RA for ≥ 2 months;\n* Receiving outpatient treatment\n* Patients naive to, and considered to be candidates for, methotrexate treatment\n\nExclusion criteria:\n\n* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA\n* Inflammatory joint disease other than RA, or other systemic autoimmune disorder\n* Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16\n* Surgery within 12 weeks of study\n* Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy\n* Concurrent treatment with any biologic agent or DMARD other than methotrexate'}, 'identificationModule': {'nctId': 'NCT00299104', 'acronym': 'IMAGE', 'briefTitle': 'A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'U3373g'}, 'secondaryIdInfos': [{'id': 'WA17047'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab (0.5 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6', 'interventionNames': ['Drug: folate', 'Drug: methotrexate', 'Drug: methylprednisolone', 'Drug: rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Rituximab (1.0 g x 2) + Methotrexate', 'description': 'Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6', 'interventionNames': ['Drug: folate', 'Drug: methotrexate', 'Drug: methylprednisolone', 'Drug: rituximab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Methotrexate', 'description': 'Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.\n\nFrom Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.', 'interventionNames': ['Drug: folate', 'Drug: methotrexate', 'Drug: methylprednisolone', 'Drug: placebo']}], 'interventions': [{'name': 'folate', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['Placebo + Methotrexate', 'Rituximab (0.5 g x 2) + Methotrexate', 'Rituximab (1.0 g x 2) + Methotrexate']}, {'name': 'methotrexate', 'type': 'DRUG', 'description': 'Oral or parenteral repeating dose', 'armGroupLabels': ['Placebo + Methotrexate', 'Rituximab (0.5 g x 2) + Methotrexate', 'Rituximab (1.0 g x 2) + Methotrexate']}, {'name': 'methylprednisolone', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['Placebo + Methotrexate', 'Rituximab (0.5 g x 2) + Methotrexate', 'Rituximab (1.0 g x 2) + Methotrexate']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['Placebo + Methotrexate']}, {'name': 'rituximab', 'type': 'DRUG', 'description': 'Intravenous repeating dose', 'armGroupLabels': ['Rituximab (0.5 g x 2) + Methotrexate', 'Rituximab (1.0 g x 2) + Methotrexate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arndt Schottelius, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}