Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT00443651
Status:
COMPLETED
Last Update Posted:
2017-04-17
First Post:
2007-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects 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': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}], 'ancestors': [{'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'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'Adverse events (AE) were recorded from the time when informed consent was obtained until Week 48, Week 4 of the safety follow-up (SFU) period, or early discontinuation. Beyond Week 4 of the SFU period, only serious or infectious AEs were recorded.', 'description': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.', 'otherNumAtRisk': 401, 'otherNumAffected': 278, 'seriousNumAtRisk': 401, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.', 'otherNumAtRisk': 176, 'otherNumAffected': 128, 'seriousNumAtRisk': 176, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colitis ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastritis hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Yolk sac tumor site unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hemicephalalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sleep apnea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Microcytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 401, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first treatment with rituximab (Day 1) through Week 24', 'description': 'An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'title': '1st infusion, 1st course of treatment', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': '2nd infusion, 1st course of treatment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': '1st infusion, 2nd course of treatment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': '2nd infusion, 2nd course of treatment', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of rituximab treatment through 24 hours', 'description': 'The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '321', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of the second course of rituximab treatment through Week 48', 'description': 'An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'title': 'ACR20 at Week 24', 'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000'}, {'value': '30.7', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 at Week 24', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 at Week 24', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'ACR20 at Week 48', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'ACR50 at Week 48', 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'ACR70 at Week 48', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'title': 'DAS 28-ESR Remission at Week 24 (n=391, 171)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'DAS 28-ESR Low DA at Week 24 (n=391, 171)', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'DAS 28-ESR Remission at Week 48 (n=389, 172)', 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'DAS 28-ESR Low DA at Week 48 (n=389, 172)', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '22.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and Week 48', 'description': 'DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of \\< 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab). There were 401 patients in the rituximab 1000 mg and 176 patients in the 500 mg safety populations. n = number of patients with non-missing DAS28-ESR last observation carried forward scores at Weeks 24 and 48 in the safety populations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'title': 'Good EULAR Response at Week 24', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate EULAR Response at Week 24', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}]}]}, {'title': 'Good EULAR Response at Week 48', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate EULAR Response at Week 48', 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement \\> 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score \\> 3.2 to ≤ 5.1, an improvement \\> 0.6 was a moderate response. For a post-baseline score \\> 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores \\> 3.2.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}, {'type': 'SECONDARY', 'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'OG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.474', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.495', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.508', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.512', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All patients who were enrolled in the study and received any study drug (rituximab).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'FG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '160'}]}, {'type': 'Week 48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed the study or the safety follow-up period.', 'groupId': 'FG000', 'numSubjects': '306'}, {'comment': 'Completed the study or the safety follow-up period.', 'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': "Patient's/Guardian's Decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted in 2 stages. Stage I: Patients with an inadequate response to non-biological disease-modifying antirheumatic drugs (DMARDS) were treated with rituximab 1000 mg. Stage II: Patients with an inadequate response to a biological DMARD were treated with rituximab 500 mg. Both groups continued to receive DMARDs.', 'preAssignmentDetails': 'One Stage 1 patient was enrolled but did not receive treatment with rituximab, is not included in the Participant Flow data, and was not included in any of the analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '577', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab 1000 mg (Stage I Patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'BG001', 'title': 'Rituximab 500 mg (Stage II Patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 - 25 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '26 - 35 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': '36 - 45 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}, {'title': '46 - 55 years', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': '56 - 65 years', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}, {'title': '66 - 75 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '76 - 85 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '> 85', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 578}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2007-03-02', 'resultsFirstSubmitDate': '2012-04-18', 'studyFirstSubmitQcDate': '2007-03-02', 'lastUpdatePostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-31', 'studyFirstPostDateStruct': {'date': '2007-03-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment', 'timeFrame': 'From first treatment with rituximab (Day 1) through Week 24', 'description': 'An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Who Developed a Serious Adverse Event (SAE) During or Within 24 Hours of Rituximab Infusions', 'timeFrame': 'From start of rituximab treatment through 24 hours', 'description': 'The percentage of patients developing a SAE during or within 24 hours of a rituximab infusion is reported separately for each of the 2 infusions in the first course of treatment (Days 1 and 15) and the second course of treatment (optional retreatment during Weeks 24 to 40). See the Primary Outcome Measure for a definition of a SAE.'}, {'measure': 'Percentage of Patients Who Developed a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the Second Course (Optional Retreatment) of Rituximab Treatment', 'timeFrame': 'From start of the second course of rituximab treatment through Week 48', 'description': 'An adverse event (AE) is any unfavorable and unintended sign, symptom, significantly abnormal laboratory finding, or disease temporally associated with the use of an investigational medical product or other protocol-imposed intervention. An AE was classified as an SAE if it: Resulted in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product; required or prolonged inpatient hospitalization; was life-threatening or considered a significant medical event by the investigator.'}, {'measure': 'Percentage of Patients With an Improvement of 20%, 50%, and 70% in American College of Rheumatology (ACR) Scores (ACR20/50/70) From Baseline at Weeks 24 and 48', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C reactive protein or, if missing, erythrocyte sedimentation rate.'}, {'measure': 'Percentage of Patients Achieving Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS 28-ESR) Remission and DAS 28-ESR Low Disease Activity Scores at Weeks 24 and 48', 'timeFrame': 'Week 24 and Week 48', 'description': 'DAS 28-ESR was calculated using counts of tender and swollen joints (28 joints, 28TJC and 28SJC), a patient assessment (PA) of disease activity (DA) in previous 24 hours on a visual analog scale (no DA to maximum DA), and ESR at the current visit, using the following formula: 0.56 × 28TJC + 0.28 × 28SJC + 0.70 × ln(ESR) + 0.014 × PADA. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. DAS28-ESR Remission was defined as a DAS 28-ESR score of \\< 2.6. DAS28-ESR Low Disease Activity was defined as a DAS28-ESR score of ≤ 3.2.'}, {'measure': 'Percentage of Patients With European League Against Rheumatism (EULAR) Good and Moderate Responses at Weeks 24 and 48', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'Improvement in the post-baseline DAS 28-ESR score from baseline was used to determine the EULAR responses of moderate response and good response. The DAS 28-ESR score ranges from 0 to 10, with higher scores indicating more rheumatoid arthritis. For a post-baseline score ≤ 3.2, an improvement \\> 0.6 to ≤ 1.2 was a moderate response and ≥ 1.2 a good response. For a post-baseline score \\> 3.2 to ≤ 5.1, an improvement \\> 0.6 was a moderate response. For a post-baseline score \\> 5.1, an improvement ≥ 1.2 was a moderate response. A good response could not be achieved for post-baseline scores \\> 3.2.'}, {'measure': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Change From Baseline at Weeks 24 and 48', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'The HAQ-DI assesses how well the patient is able to perform 8 activities: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The patient answers 20 questions with 1 of 4 responses with the past week as the time frame: 0=without difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The highest score for any question in a category determines the category score. The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.'}]}, 'conditionsModule': {'keywords': ['Rituxan', 'RA', 'DMARD', 'Active Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '23547218', 'type': 'DERIVED', 'citation': 'Rigby WF, Mease PJ, Olech E, Ashby M, Tole S. Safety of rituximab in combination with other biologic disease-modifying antirheumatic drugs in rheumatoid arthritis: an open-label study. J Rheumatol. 2013 May;40(5):599-604. doi: 10.3899/jrheum.120924. Epub 2013 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, open-label study of a total of approximately 560 subjects with active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Enrollment in the study was conducted in two stages. In Stage I of the study, approximately 400 subjects receiving non-biological DMARDs (with the exception of methotrexate \\[MTX\\] monotherapy or MTX and leflunomide combination therapy) were enrolled. In Stage II of the study, approximately 160 subjects receiving a Federal Drug Administration-approved biological DMARD at the time of screening were enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (Stage I):\n\n* Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active rheumatoid arthritis (RA) for ≥ 6 months\n* Receiving treatment for RA on an outpatient basis\n* Have had an inadequate response to at least one non-biological disease-modifying anti-rheumatic drug (DMARD) and have been receiving this DMARD(s) for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline\n* Demonstrated tolerability to currently prescribed DMARDs\n* If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to the first day of treatment with rituximab (Day 1)\n* Use of one nonsteroidal anti-inflammatory drug (NSAID) is permitted if the dose is stable for ≥ 2 weeks prior to Day 1\n\nExclusion Criteria (Stage I):\n\n* Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)\n* Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis\n* History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder\n* Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years\n* Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of enrollment\n* Lack of peripheral venous access\n* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)\n* Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation\n* Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection\n* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline\n* History of medically significant opportunistic infection\n* History of serious recurrent or chronic infection\n* History of deep space/tissue infection within 52 weeks prior to baseline\n* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)\n* History of significant cytopenias or other bone marrow disorders\n* History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline\n* Pregnancy or lactation\n* Neuropathies and neurovasculopathies that might interfere with pain evaluation\n* Methotrexate (MTX) monotherapy at the time of screening\n* Concurrent treatment with MTX and leflunomide in combination\n* Concurrent treatment with any biologic agent\n* Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol\n* History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins\n* Previous treatment with an anti-α4 integrin agent\n* Previous treatment with any cell-depleting therapies, including investigational agents\n* Receipt of any vaccine within 28 days prior to baseline\n* Intolerance or contraindications to IV corticosteroids\n* Receipt of IV immunoglobulin (IVIG) or Prosorba\\<TM\\> column within 6 months prior to baseline\n* Any previous treatment with rituximab\n* Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody\n\nInclusion Criteria (Stage II):\n\n* Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active RA for ≥ 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA\n* Receiving treatment for RA on an outpatient basis\n* Have had an inadequate response to at least one biologic DMARD and have been receiving this agent at screening and for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline\n* Have demonstrated tolerability to currently prescribed DMARDs/biologics\n* If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to baseline\n* Use of one NSAID is permitted if the dose is stable for ≥ 2 weeks prior to baseline\n\nExclusion Criteria (Stage II):\n\n* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)\n* Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis\n* History of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder\n* Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years\n* Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of randomization\n* Lack of peripheral venous access\n* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)\n* Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation\n* Primary or secondary immunodeficiency (history of or currently active), including known history of HIV infection\n* Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline\n* History of medically significant opportunistic infection\n* History of serious recurrent or chronic infection\n* History of deep space/tissue infection within 52 weeks prior to baseline\n* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)\n* History of significant cytopenias or other bone marrow disorders\n* History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline\n* Pregnancy or lactation\n* Neuropathies and neurovasculopathies that might interfere with pain evaluation\n* Infliximab monotherapy at the time of screening (infliximab should be in combination with MTX)\n* Concurrent treatment with MTX and leflunomide in combination\n* Concurrent treatment with more than one biologic agent\n* Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol\n* History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins\n* Previous treatment with an anti-α4 integrin agent\n* Previous treatment with any cell-depleting therapies\n* Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (whichever is the longer)\n* Receipt of any vaccine within 28 days prior to baseline\n* Intolerance or contraindications to IV corticosteroids\n* Receipt of IVIG or Prosorba\\<TM\\> column within 6 months prior to baseline\n* Any previous treatment with rituximab\n* Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody\n* Positive purified protein derivative (PPD) skin test not adequately treated according to Center for Disease Control (CDC) guidelines"}, 'identificationModule': {'nctId': 'NCT00443651', 'acronym': 'SUNDIAL', 'briefTitle': 'A Study of the Safety of Rituximab in Combination With Other Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-Label, Prospective Study of the Safety of Rituximab in Combination With Other Disease-Modifying Anti-Rheumatic Drugs in Subjects With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'U3924g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab 1000 mg (Stage I patients)', 'description': 'Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.', 'interventionNames': ['Drug: Rituximab', 'Drug: Anti-inflammatory drugs']}, {'type': 'EXPERIMENTAL', 'label': 'Rituximab 500 mg (Stage II patients)', 'description': 'Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.', 'interventionNames': ['Drug: Rituximab', 'Drug: Anti-inflammatory drugs']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'description': 'Rituximab was supplied as a concentrate for IV administration at a concentration of 10 mg/mL in 500 mg (50 mL) single-use vials.', 'armGroupLabels': ['Rituximab 1000 mg (Stage I patients)', 'Rituximab 500 mg (Stage II patients)']}, {'name': 'Anti-inflammatory drugs', 'type': 'DRUG', 'description': 'Each rituximab infusion was preceded by methylprednisolone 100 mg IV. Use of stable doses of oral corticosteroids was permitted (≤ 10 mg of prednisone or equivalent per day) as were stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs).', 'armGroupLabels': ['Rituximab 1000 mg (Stage I patients)', 'Rituximab 500 mg (Stage II patients)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Micki Klearman, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}