Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2026-01-01 @ 4:08 AM
Study NCT ID:
NCT01526057
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
2012-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, '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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected for 28 days after the last administration of study drug or, in the case of incomplete B-cell count recovery, for up to 1 year after Study Day 1.', 'description': 'The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.', 'otherNumAtRisk': 73, 'otherNumAffected': 49, 'seriousNumAtRisk': 73, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.', 'otherNumAtRisk': 74, 'otherNumAffected': 40, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.', 'otherNumAtRisk': 73, 'otherNumAffected': 45, 'seriousNumAtRisk': 73, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Costochondritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eyelid pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal 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0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 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'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and 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'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Campbell de Morgan spots', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bone neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Serum Concentration (Cmax) of Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '453', 'spread': '153', 'groupId': 'OG000'}, {'value': '422', 'spread': '111', 'groupId': 'OG001'}, {'value': '430', 'spread': '163', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.67', 'ciLowerLimit': '96.91', 'ciUpperLimit': '115.21', 'estimateComment': 'Rituximab-Pfizer is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way analysis of variance (ANOVA) model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and area under the serum concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC 0-inf) are within the 80.00% to 125.00% range.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.62', 'ciLowerLimit': '97.65', 'ciUpperLimit': '116.41', 'estimateComment': 'Rituximab-Pfizer is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.90', 'ciLowerLimit': '92.38', 'ciUpperLimit': '110.20', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC 0-inf are within the 80.00% to 125.00% range.'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.', 'unitOfMeasure': 'micrograms per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population: all participants who were randomized, received the full doses of the assigned study treatment, and had no major protocol violations that could impact the pharmacokinetic (PK) analysis. Exclusions from the PP population were based on a blinded data review by the Medical Monitor and Clinical Pharmacologist.'}, {'type': 'PRIMARY', 'title': 'AUC 0-inf of Rituximab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '213000', 'spread': '90400', 'groupId': 'OG000'}, {'value': '200000', 'spread': '74500', 'groupId': 'OG001'}, {'value': '214000', 'spread': '95300', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.19', 'ciLowerLimit': '92.75', 'ciUpperLimit': '117.06', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100.45', 'ciLowerLimit': '89.20', 'ciUpperLimit': '113.11', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.40', 'ciLowerLimit': '85.57', 'ciUpperLimit': '108.60', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'PK similarity for a given test-to-reference comparison would be demonstrated if the 90% CI for the test-to-reference ratios in Cmax and AUC0-inf are within the 80.00% to 125.00% range.'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.', 'unitOfMeasure': 'ug*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '52100', 'spread': '18000', 'groupId': 'OG000'}, {'value': '49600', 'spread': '14200', 'groupId': 'OG001'}, {'value': '49200', 'spread': '15900', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.74', 'ciLowerLimit': '95.10', 'ciUpperLimit': '113.12', 'estimateComment': 'Rituximab-Pfizer is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '105.56', 'ciLowerLimit': '96.64', 'ciUpperLimit': '115.30', 'estimateComment': 'Rituximab-Pfizer is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.76', 'ciLowerLimit': '93.13', 'ciUpperLimit': '111.18', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration.', 'unitOfMeasure': 'ug*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population.'}, {'type': 'SECONDARY', 'title': 'Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '198000', 'spread': '79600', 'groupId': 'OG000'}, {'value': '188000', 'spread': '64300', 'groupId': 'OG001'}, {'value': '196000', 'spread': '78300', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '103.36', 'ciLowerLimit': '92.81', 'ciUpperLimit': '115.12', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.33', 'ciLowerLimit': '90.82', 'ciUpperLimit': '113.04', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Test-to-reference ratio: adjusted means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.03', 'ciLowerLimit': '87.83', 'ciUpperLimit': '109.40', 'groupDescription': 'A 90% CI on the estimated difference between 2 treatment groups was constructed using a 1-way ANOVA model based on natural log-transformed data. The estimated differences for the log-transformed PK parameters were then transformed to relative ratios of PK parameters by exponentiation.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T.', 'unitOfMeasure': 'ug*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population.'}, {'type': 'SECONDARY', 'title': 'CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '13312', 'spread': '13309', 'groupId': 'OG000'}, {'value': '14304', 'spread': '13146', 'groupId': 'OG001'}, {'value': '12496', 'spread': '13500', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T.', 'unitOfMeasure': 'cells*day/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Minimum Post-Baseline CD19+ B-cell Count (/uL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': "The lowest CD19+ B-cell count measured in a participant's blood post-baseline.", 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '1.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of B-cell Depletion (τB-cell) (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '126', 'spread': '41.8', 'groupId': 'OG000'}, {'value': '123', 'spread': '38.6', 'groupId': 'OG001'}, {'value': '120', 'spread': '40.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The τB-cell is defined as the time interval over which the B-cell count was \\<0.3 cells/uL or the detection limit.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CD19+ B-cell Count Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '8.7', 'groupId': 'OG001'}, {'value': '9.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25', 'description': 'The percentage of participants with CD19+ B-cell counts which fell to \\<50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '13312.1', 'spread': '13309.15', 'groupId': 'OG000'}, {'value': '14304.2', 'spread': '13145.72', 'groupId': 'OG001'}, {'value': '12495.9', 'spread': '13499.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T.', 'unitOfMeasure': 'cells*day/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.381', 'spread': '0.7617', 'groupId': 'OG000'}, {'value': '1.460', 'spread': '0.8076', 'groupId': 'OG001'}, {'value': '1.394', 'spread': '0.8372', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '0.33', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.34', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '18.62', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '9.57', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '9.93', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '12.45', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '9.42', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '14.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '9.95', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '9.82', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.5', 'spread': '14.77', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '10.59', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '21.89', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.6', 'spread': '16.00', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '15.60', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '14.39', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.4', 'spread': '13.68', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '13.69', 'groupId': 'OG001'}, {'value': '-14.1', 'spread': '13.73', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '37.17', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '13.92', 'groupId': 'OG001'}, {'value': '-16.2', 'spread': '30.14', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '226.39', 'groupId': 'OG000'}, {'value': '-23.7', 'spread': '16.35', 'groupId': 'OG001'}, {'value': '-21.6', 'spread': '14.88', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-21.6', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '-24.7', 'spread': '21.00', 'groupId': 'OG001'}, {'value': '-21.3', 'spread': '15.69', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-24.2', 'spread': '14.63', 'groupId': 'OG000'}, {'value': '-21.0', 'spread': '16.95', 'groupId': 'OG001'}, {'value': '-20.5', 'spread': '21.78', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25', 'description': 'The percentage change from Baseline in circulating IgM by visit.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '33.8', 'groupId': 'OG001'}, {'value': '32.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}, {'value': '42.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '60.8', 'groupId': 'OG001'}, {'value': '58.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '70.3', 'groupId': 'OG001'}, {'value': '63.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '67.6', 'groupId': 'OG001'}, {'value': '67.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '54.2', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}, {'value': '71.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '2.7', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '16.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '23.0', 'groupId': 'OG001'}, {'value': '20.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}, {'value': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}, {'value': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '32.4', 'groupId': 'OG001'}, {'value': '35.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '40.5', 'groupId': 'OG001'}, {'value': '31.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}, {'value': '37.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '37.8', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '38.1', 'groupId': 'OG001'}, {'value': '33.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants by Anti-drug Antibody (ADA) Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 up to Day 169.', 'description': 'Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 169', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. Only participants with a positive ADA status were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6862', 'spread': '0.85109', 'groupId': 'OG000'}, {'value': '5.7928', 'spread': '0.9503', 'groupId': 'OG001'}, {'value': '6.2221', 'spread': '0.88162', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.02', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-2.3', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.39', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '1.35', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '1.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (\\>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (\\<)2.6 implied remission.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in DAS28-CRP by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.1', 'spread': '19.08', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '20.41', 'groupId': 'OG001'}, {'value': '-18.6', 'spread': '17.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-25.4', 'spread': '20.74', 'groupId': 'OG000'}, {'value': '-24.0', 'spread': '18.22', 'groupId': 'OG001'}, {'value': '-26.0', 'spread': '21.88', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-31.2', 'spread': '22.31', 'groupId': 'OG000'}, {'value': '-31.0', 'spread': '21.92', 'groupId': 'OG001'}, {'value': '-34.2', 'spread': '22.97', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-34.7', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '-36.9', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '-37.4', 'spread': '21.42', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-34.9', 'spread': '22.65', 'groupId': 'OG000'}, {'value': '-35.4', 'spread': '23.28', 'groupId': 'OG001'}, {'value': '-39.1', 'spread': '21.35', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-35.5', 'spread': '21.99', 'groupId': 'OG000'}, {'value': '-33.4', 'spread': '22.56', 'groupId': 'OG001'}, {'value': '-43.2', 'spread': '21.39', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-31.1', 'spread': '22.72', 'groupId': 'OG000'}, {'value': '-34.6', 'spread': '22.25', 'groupId': 'OG001'}, {'value': '-40.0', 'spread': '20.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (\\>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (\\<)2.6 implied remission.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}, {'value': '8.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}, {'value': '25.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '36.2', 'groupId': 'OG001'}, {'value': '41.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '35.1', 'groupId': 'OG001'}, {'value': '42.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000'}, {'value': '39.4', 'groupId': 'OG001'}, {'value': '43.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}, {'value': '54.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.8', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}, {'value': '44.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '39.4', 'groupId': 'OG001'}, {'value': '53.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}, {'value': '39.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '46.6', 'groupId': 'OG001'}, {'value': '43.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With No EULAR Response Based on DAS28 by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000'}, {'value': '54.1', 'groupId': 'OG001'}, {'value': '49.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '37.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000'}, {'value': '18.1', 'groupId': 'OG001'}, {'value': '22.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}, {'value': '22.5', 'groupId': 'OG001'}, {'value': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '17.2', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '10.8', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '19.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000'}, {'value': '32.9', 'groupId': 'OG001'}, {'value': '25.7', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '32.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '36.9', 'groupId': 'OG001'}, {'value': '47.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}, {'value': '41.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.78', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.88', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.73', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.56', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.62', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.69', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.70', 'ciUpperLimit': '2.00', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.73', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.54', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.42', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.22', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.44', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '0.88', 'ciUpperLimit': '2.10', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '0.78', 'ciUpperLimit': '2.18', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.36', 'ciUpperLimit': '2.45', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.44', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.47', 'ciUpperLimit': '1.31', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.13', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.55', 'ciUpperLimit': '1.36', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.29', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.95', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.73', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS Remission (DAS <2.6) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}, {'value': '7.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '11.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}, {'value': '25.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '25.4', 'groupId': 'OG001'}, {'value': '23.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}, {'value': '30.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '24.1', 'groupId': 'OG001'}, {'value': '23.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.12', 'ciUpperLimit': '1.79', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.20', 'ciUpperLimit': '1.26', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.43', 'ciUpperLimit': '1.41', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.74', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.74', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.34', 'ciUpperLimit': '1.36', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.63', 'estimateComment': 'Rituximab-EU is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-EU versus rituximab-Pfizer at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.27', 'ciUpperLimit': '2.60', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.31', 'ciUpperLimit': '1.62', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.40', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.57', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.68', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.68', 'ciUpperLimit': '2.19', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.44', 'ciUpperLimit': '1.62', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-Pfizer at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.44', 'ciUpperLimit': '7.20', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 3.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '0.52', 'ciUpperLimit': '3.86', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 5.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.87', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 9.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.50', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 13.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.69', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 17.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '0.93', 'ciUpperLimit': '3.50', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 21.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.89', 'estimateComment': 'Rituximab-US is the numerator.', 'groupDescription': 'Statistical analysis of rituximab-US versus rituximab-EU at Week 25 (EOT).', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \\<2.6 implied remission. p-value of 9999 indicates p-value is not applicable.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.6541', 'spread': '0.57340', 'groupId': 'OG000'}, {'value': '1.5929', 'spread': '0.53597', 'groupId': 'OG001'}, {'value': '1.7466', 'spread': '0.62081', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.33', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.54', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.55', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '0.57', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3, 5, 9, 13, 17, 21 and 25', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Number Analyzed" = participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HAQ-DI Score by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'OG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.4', 'spread': '37.27', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '26.03', 'groupId': 'OG001'}, {'value': '-9.0', 'spread': '25.68', 'groupId': 'OG002'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-15.1', 'spread': '40.00', 'groupId': 'OG000'}, {'value': '-23.5', 'spread': '30.45', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '43.82', 'groupId': 'OG002'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-22.4', 'spread': '35.96', 'groupId': 'OG000'}, {'value': '-31.7', 'spread': '34.64', 'groupId': 'OG001'}, {'value': '-24.5', 'spread': '35.51', 'groupId': 'OG002'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.6', 'spread': '50.35', 'groupId': 'OG000'}, {'value': '-39.5', 'spread': '37.46', 'groupId': 'OG001'}, {'value': '-30.7', 'spread': '31.91', 'groupId': 'OG002'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-16.9', 'spread': '48.95', 'groupId': 'OG000'}, {'value': '-39.1', 'spread': '38.85', 'groupId': 'OG001'}, {'value': '-28.8', 'spread': '36.43', 'groupId': 'OG002'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-21.0', 'spread': '48.04', 'groupId': 'OG000'}, {'value': '-39.2', 'spread': '38.34', 'groupId': 'OG001'}, {'value': '-33.5', 'spread': '35.18', 'groupId': 'OG002'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-17.7', 'spread': '54.01', 'groupId': 'OG000'}, {'value': '-37.1', 'spread': '41.18', 'groupId': 'OG001'}, {'value': '-38.4', 'spread': '34.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3, 5, 9, 13, 17, 21 and 25', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure. "Number Analyzed" = participants evaluable at specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received intravenous (IV) rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 milligram \\[mg\\] methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg per week (mg/week) (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'FG001', 'title': 'Rituximab-European Union (EU)', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'FG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a multinational, randomized, double-blind, controlled trial in participants with active rheumatoid arthritis (RA) on a background of methotrexate (MTX). The study was conducted at 56 centres in 10 countries. There were a total of 220 participants enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '220', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab-Pfizer', 'description': 'Participants received IV rituximab (PF-05280586) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'BG001', 'title': 'Rituximab-EU', 'description': 'Participants received IV rituximab (MabThera) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'BG002', 'title': 'Rituximab-US', 'description': 'Participants received IV rituximab (Rituxan) infusion 1000 milligrams per 500 milliliters (preceded by 100 mg methylprednisolone, an antipyretic such as paracetamol, and an antihistamine such as diphenhydramine) on Day 1 and 15 and continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '11.52', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '11.07', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '11.87', 'groupId': 'BG002'}, {'value': '54.4', 'spread': '11.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (mITT) population included all participants who were randomized and received at least 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2014-09-09', 'completionDateStruct': {'date': '2014-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-30', 'studyFirstSubmitDate': '2012-02-01', 'dispFirstSubmitQcDate': '2014-09-09', 'resultsFirstSubmitDate': '2019-09-06', 'studyFirstSubmitQcDate': '2012-02-02', 'dispFirstPostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-30', 'studyFirstPostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Serum Concentration (Cmax) of Rituximab', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.'}, {'measure': 'AUC 0-inf of Rituximab', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.'}], 'secondaryOutcomes': [{'measure': 'Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration.'}, {'measure': 'Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)', 'timeFrame': 'Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion', 'description': 'The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T.'}, {'measure': 'CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T.'}, {'measure': 'Minimum Post-Baseline CD19+ B-cell Count (/uL)', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': "The lowest CD19+ B-cell count measured in a participant's blood post-baseline."}, {'measure': 'Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count.'}, {'measure': 'Duration of B-cell Depletion (τB-cell) (Days)', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The τB-cell is defined as the time interval over which the B-cell count was \\<0.3 cells/uL or the detection limit.'}, {'measure': 'Percentage of Participants With CD19+ B-cell Count Recovery', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25', 'description': 'The percentage of participants with CD19+ B-cell counts which fell to \\<50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment.'}, {'measure': 'Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)', 'timeFrame': 'Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T.'}, {'measure': 'Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit.'}, {'measure': 'Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)', 'timeFrame': 'Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25', 'description': 'The percentage change from Baseline in circulating IgM by visit.'}, {'measure': 'Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \\[HAQ\\]); and C-Reactive Protein (CRP).\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.'}, {'measure': 'Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)', 'description': 'ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on.'}, {'measure': 'Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.\n\nNon-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on.'}, {'measure': 'Percentage of Participants by Anti-drug Antibody (ADA) Status', 'timeFrame': 'Days 1 up to Day 169.', 'description': 'Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status.'}, {'measure': 'Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit', 'timeFrame': 'Day 1 up to Day 169'}, {'measure': 'Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (\\>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (\\<)2.6 implied remission.'}, {'measure': 'Percent Change From Baseline in DAS28-CRP by Visit', 'timeFrame': 'Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (\\>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (\\<)2.6 implied remission.'}, {'measure': 'Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.'}, {'measure': 'Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.'}, {'measure': 'Percentage of Participants With No EULAR Response Based on DAS28 by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \\>1.2 with DAS28 ≤3.2; moderate responders: change from baseline \\>1.2 with DAS28 \\>3.2 to ≤5.1 or change from baseline \\>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline \\>0.6 and ≤1.2 with DAS28 \\>5.1.'}, {'measure': 'Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable.'}, {'measure': 'Percentage of Participants With DAS Remission (DAS <2.6) by Visit', 'timeFrame': 'Weeks 3, 5, 9, 13, 17, 21 and 25', 'description': 'DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \\<2.6 implied remission. p-value of 9999 indicates p-value is not applicable.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit', 'timeFrame': 'Baseline, Week 3, 5, 9, 13, 17, 21 and 25', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Percent Change From Baseline in HAQ-DI Score by Visit', 'timeFrame': 'Baseline, Week 3, 5, 9, 13, 17, 21 and 25', 'description': 'HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'rituximab', 'methotrexate', 'anti-TNF'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27530379', 'type': 'DERIVED', 'citation': 'Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3281001&StudyName=A%20Pharmacokinetic/Pharmacodynamic%20Study%20Comparing%20PF-05280586%20To%20Rituximab%20In%20Subjects%20With%20Active%20Rheumatoid%20Arthritis%20With%20An%20Inadequate%20Res', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of rheumatoid arthritis\n* Meets Class I, II or III of the ACR 1991 Revised Criteria\n* RA seropositivity\n* Stable dose of methotrexate\n* Inadequate response to TNF inhibitors\n\nExclusion Criteria:\n\n* Any prior treatment with lymphocyte depleting therapies\n* History of active TB infection\n* Known or screen test positive for specific viruses or indicators of viral infection'}, 'identificationModule': {'nctId': 'NCT01526057', 'acronym': 'REFLECTIONS', 'briefTitle': 'A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES', 'orgStudyIdInfo': {'id': 'B3281001'}, 'secondaryIdInfos': [{'id': 'ICON 9002/010'}, {'id': '2011-002896-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - PF-05280586', 'interventionNames': ['Biological: PF-05280586']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B - Rituximab EU', 'interventionNames': ['Biological: MabThera']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C- Rituximab-US', 'interventionNames': ['Biological: Rituxan']}], 'interventions': [{'name': 'PF-05280586', 'type': 'BIOLOGICAL', 'description': '1000 mg, IV on days 1 and 15', 'armGroupLabels': ['A - PF-05280586']}, {'name': 'MabThera', 'type': 'BIOLOGICAL', 'description': '1000 mg, IV on days 1 and 15', 'armGroupLabels': ['B - Rituximab EU']}, {'name': 'Rituxan', 'type': 'BIOLOGICAL', 'description': '1000 mg, IV on days 1 and 15', 'armGroupLabels': ['C- Rituximab-US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Bermingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates of North Alabama, PC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'ArthroCare, Arthritis Care & Research, PC', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Mercy Clinic Hot Springs Communities', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90095-1670', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA David Geffen School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92260', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Desert Medical Advances', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Advances In Medicine', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Research Assoc. 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