Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-06 @ 6:16 AM
Study NCT ID:
NCT01682512
Status:
TERMINATED
Last Update Posted:
2018-01-30
First Post:
2012-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Estonia', 'France', 'Guatemala', 'Italy', 'New Zealand', 'Norway', 'Peru', 'Russia', 'Serbia', 'South Africa', 'Sweden']}, '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': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study program was terminated and this study was discontinued on 3 September 2015. As a result no patients receiving study treatment in Part II of the study reached Week 24, and no conclusions regarding the efficacy of BI 695500 can be made.'}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study medication and prior to the last date of study medication plus 6 months (180 days); up to 48 weeks', 'description': 'The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.', 'otherNumAtRisk': 116, 'otherNumAffected': 17, 'seriousNumAtRisk': 116, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.', 'otherNumAtRisk': 110, 'otherNumAffected': 14, 'seriousNumAtRisk': 110, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.', 'otherNumAtRisk': 65, 'otherNumAffected': 24, 'seriousNumAtRisk': 65, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anaphylactoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abscess neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 65, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-2.08', 'upperLimit': '-1.50'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.64', 'upperLimit': '-1.09'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.03', 'pValueComment': 'Model analyzed was: DAS28(ESR) change from Baseline at Week 24 = overall mean + treatment + DAS28(ESR) Baseline score + visit + visit by treatment interaction + baseline-by-visit interaction + random error.', 'estimateComment': 'Adjusted mean difference was calculated as: BI 695500 - Rituxan®', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A restricted maximum likelihood (REML)-based Mixed-Effect Model Repeated Measure (MMRM) approach was used.', 'nonInferiorityComment': 'Equivalence for the change in DAS28 (ESR) was evaluated based on the two-sided 90% Confidence Interval (CI) for the treatment difference with respect to the mean change in the DAS28(ESR) score compared to baseline. Null hypothesis of non-equivalence was to be rejected if the 90% CI is fully contained within the interval of \\[-0.5, 0.5\\].'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.70\\*ln(ESR) + 0.014\\*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS \\[score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)\\].\n\nDAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of \\< 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.\n\nThe full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit.', 'unitOfMeasure': 'Unit on scale', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Since this endpoint was designed to establish statistical equivalence of efficacy of BI 695500 and Rituxan®, only subjects randomized to BI 695500 and Rituxan® in part-I of study are included.'}, {'type': 'PRIMARY', 'title': 'PK (Part I Only): AUC0-tz (Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration, Determined Over Both Dosages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '171000', 'spread': '41.1', 'groupId': 'OG000'}, {'value': '167000', 'spread': '40.5', 'groupId': 'OG001'}, {'value': '193000', 'spread': '37.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.35', 'ciLowerLimit': '90.50', 'ciUpperLimit': '115.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.700', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and Rituxan.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '88.21', 'ciLowerLimit': '78.24', 'ciUpperLimit': '99.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.500', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o- tz) was compared between treatment groups BI 695500 and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.18', 'ciLowerLimit': '76.50', 'ciUpperLimit': '97.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.449', 'estimateComment': 'Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o- tz) was compared between treatment groups Rituxan and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-tz)=overall mean+treatment effect+random error'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'Pharmacokinetic (PK) (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, determined over both dosages). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. As per protocol all the following criteria had to be fulfilled for a patient to be defined as PK evaluable for the Pharmacokinetic analysis set (PKS):\n\nFull first and second dose given. Pre-dose concentration available prior to the second dose. Ability to estimate AUC during the infusion phases. Ability to estimate the AUC for the distribution phase after the second dose. Ability to estimate the terminal half-life (t1/2) after the second dose.\n\ngMean - Geometric Mean', 'unitOfMeasure': 'Hour(h)*Microgram(ug)/Milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS) consisted of all randomized subjects who were PK evaluable based on protocol defined criteria.'}, {'type': 'PRIMARY', 'title': 'PK (Part I Only): AUC0-inf Pred (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Determined Over Both Dosages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '174000', 'spread': '42.2', 'groupId': 'OG000'}, {'value': '169000', 'spread': '42.0', 'groupId': 'OG001'}, {'value': '202000', 'spread': '35.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.46', 'ciLowerLimit': '90.26', 'ciUpperLimit': '116.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.939', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and Rituxan.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.00', 'ciLowerLimit': '76.38', 'ciUpperLimit': '96.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.404', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o-inf pred) was compared between treatment groups BI 695500 and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '83.93', 'ciLowerLimit': '74.57', 'ciUpperLimit': '94.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.386', 'estimateComment': 'Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(o-inf pred) was compared between treatment groups Rituxan and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf pred)=overall mean+treatment effect+random error'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, determined over both dosages, and extrapolated to infinity using predicted last observed quantifiable concentration). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'PRIMARY', 'title': 'PK (Part I Only): AUC0-336 (Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '49800', 'spread': '40.1', 'groupId': 'OG000'}, {'value': '51900', 'spread': '28.9', 'groupId': 'OG001'}, {'value': '55600', 'spread': '30.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.87', 'ciLowerLimit': '86.21', 'ciUpperLimit': '106.62', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '106.608', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-336) was compared between treatment groups BI 695500 and Rituxan.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.46', 'ciLowerLimit': '80.23', 'ciUpperLimit': '99.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '106.775', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-336) was compared between treatment groups BI 695500 and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.31', 'ciLowerLimit': '85.11', 'ciUpperLimit': '102.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.700', 'estimateComment': 'Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-336) was compared between treatment groups Rituxan and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-336)=overall mean+treatment effect+random error'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours after the first dose). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'PRIMARY', 'title': 'PK (Part I Only): Observed Cmax (Maximum Plasma Concentration, Determined After the Second Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '434', 'spread': '31.1', 'groupId': 'OG000'}, {'value': '462', 'spread': '32.0', 'groupId': 'OG001'}, {'value': '486', 'spread': '28.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '93.97', 'ciLowerLimit': '85.32', 'ciUpperLimit': '103.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.995', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error', 'groupDescription': 'The similarity of observed Cmax was compared between treatment groups BI 695500 and Rituxan.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.30', 'ciLowerLimit': '81.51', 'ciUpperLimit': '97.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.657', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of observed Cmax was compared between treatment groups BI 695500 and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.02', 'ciLowerLimit': '86.62', 'ciUpperLimit': '104.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '105.744', 'estimateComment': 'Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of observed Cmax was compared between treatment groups Rituxan and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(Cmax)=overall mean+treatment effect+random error'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): observed Cmax (observed maximum plasma concentration, determined after the second dose). Only subjects randomized in part I of this study are included.', 'unitOfMeasure': 'microgram per milliliter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "A subject has an ACR20 response if all of the following occur:\n\n* a \\> 20% improvement in the swollen joint count (66 joints)\n* a \\> 20% improvement in the tender joint count (68 joints)\n* a \\> 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (C-reactive protein).\n\nThe percentage of subjects meeting the ACR20 response criteria at Week 24 (part-I and II) is presented for subjects randomised to receive BI 695500, Rituxan and MabThera.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Missing data have been imputed according to LOCF (last observation carried forward) and/or NRI (Non Responder Imputation).'}, {'type': 'SECONDARY', 'title': 'PK (Part I Only): AUC0-inf, Ppk (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Based on Individual Predicted Concentrations for Missing Data Derived From a Population PK Model, Determined Over Both Dosages)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'OG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '165000', 'spread': '42.9', 'groupId': 'OG000'}, {'value': '158000', 'spread': '50.0', 'groupId': 'OG001'}, {'value': '180000', 'spread': '40.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.49', 'ciLowerLimit': '91.92', 'ciUpperLimit': '118.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '108.044', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus Rituxan®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and Rituxan.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.39', 'ciLowerLimit': '81.38', 'ciUpperLimit': '102.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.253', 'estimateComment': 'Adjusted ratio of gMeans: BI 695500 versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-inf, ppk) was compared between treatment groups BI 695500 and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted ratio of gMeans (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.47', 'ciLowerLimit': '77.12', 'ciUpperLimit': '99.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '107.896', 'estimateComment': 'Adjusted ratio of gMeans: Rituxan® versus MabThera®; standard error is geometric standard error', 'groupDescription': 'The similarity of AUC(0-inf, ppk) was compared between treatment groups Rituxan and MabThera.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance (ANOVA) model on logarithmic scale: Ln(AUC0-inf, ppk)=overall mean+treatment effect+random error'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-inf, ppk. Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. A modeling approach was used to impute missing values as well as impute missing concentrations after the first dose with a sampling schedule identical to the first 2 weeks after the second dose. A unit dose of 1000 mg was used in calculating the imputed values. The resulting dataset thus consisted of PK evaluable and PK non-evaluable patients with both measured as well as imputed concentration values. The prediction of these concentrations was based on a mixed effect modeling approach and included significant covariates as identified during the PK model development (including age, body surface area \\[BSA\\], body mass index \\[BMI\\], weight, gender, race, and formulation).', 'unitOfMeasure': 'h*ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic full analysis set (PKFS) included all randomized subjects with at least one valid PK concentration measurement. A valid PK concentration measurement is a value greater than lower limit of quantification as provided by Charles River.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'FG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'FG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'Randomized in Part-I', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'Randomized in Part-II', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '46'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Primary lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Secondary lack of efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Subjects were enrolled into this multi-center, randomized, double-blind, parallel arm, multiple dose, active comparator 2 part trial from 27 September 2017. Trial was terminated on 3 September 2015 and last subject completed 28 October 2016.', 'preAssignmentDetails': '509 subjects were screened for eligibility to participate in the trial. 293 subjects met all inclusion and exclusion criteria and were randomised to receive treatment. 6 subjects were included in an open-label safety run-in prior to randomisation in Part-I.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BI 695500', 'description': 'Patients administered 1000 milligram per 100 milliliter (1000 mg per 100 mL) of BI 695500 concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'BG001', 'title': 'Rituxan®', 'description': 'Patients administered 1000 mg per 100 mL of Rituxan® injection for intravenous (IV) use each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'BG002', 'title': 'MabThera®', 'description': 'Patients administered 1000 mg per 100 mL of MabThera® concentrate for solution for intravenous (IV) infusion each at Day 1 and 15. Patients with response to treatment were administered additional infusions at Week 24 and 26.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '10.46', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '11.10', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '12.22', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '11.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '242', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety randomized analysis set (SAFR) contained all randomized subjects who received at least one dose of trial medication and subjects were classified according to treatment received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'whyStopped': 'substance discontinued', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-04', 'studyFirstSubmitDate': '2012-08-10', 'resultsFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-04', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I', 'timeFrame': 'Baseline and Week 24', 'description': 'The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56\\*√(TJC28) + 0.28\\*√(SJC28) + 0.70\\*ln(ESR) + 0.014\\*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS \\[score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)\\].\n\nDAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of \\< 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.\n\nThe full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit.'}, {'measure': 'PK (Part I Only): AUC0-tz (Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration, Determined Over Both Dosages)', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'Pharmacokinetic (PK) (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, determined over both dosages). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. As per protocol all the following criteria had to be fulfilled for a patient to be defined as PK evaluable for the Pharmacokinetic analysis set (PKS):\n\nFull first and second dose given. Pre-dose concentration available prior to the second dose. Ability to estimate AUC during the infusion phases. Ability to estimate the AUC for the distribution phase after the second dose. Ability to estimate the terminal half-life (t1/2) after the second dose.\n\ngMean - Geometric Mean'}, {'measure': 'PK (Part I Only): AUC0-inf Pred (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Determined Over Both Dosages)', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, determined over both dosages, and extrapolated to infinity using predicted last observed quantifiable concentration). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.'}, {'measure': 'PK (Part I Only): AUC0-336 (Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours)', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours after the first dose). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.'}, {'measure': 'PK (Part I Only): Observed Cmax (Maximum Plasma Concentration, Determined After the Second Dose)', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): observed Cmax (observed maximum plasma concentration, determined after the second dose). Only subjects randomized in part I of this study are included.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II', 'timeFrame': 'Week 24', 'description': "A subject has an ACR20 response if all of the following occur:\n\n* a \\> 20% improvement in the swollen joint count (66 joints)\n* a \\> 20% improvement in the tender joint count (68 joints)\n* a \\> 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (C-reactive protein).\n\nThe percentage of subjects meeting the ACR20 response criteria at Week 24 (part-I and II) is presented for subjects randomised to receive BI 695500, Rituxan and MabThera."}, {'measure': 'PK (Part I Only): AUC0-inf, Ppk (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Based on Individual Predicted Concentrations for Missing Data Derived From a Population PK Model, Determined Over Both Dosages)', 'timeFrame': 'Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.', 'description': 'PK (Part I only): AUC0-inf, ppk. Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. A modeling approach was used to impute missing values as well as impute missing concentrations after the first dose with a sampling schedule identical to the first 2 weeks after the second dose. A unit dose of 1000 mg was used in calculating the imputed values. The resulting dataset thus consisted of PK evaluable and PK non-evaluable patients with both measured as well as imputed concentration values. The prediction of these concentrations was based on a mixed effect modeling approach and included significant covariates as identified during the PK model development (including age, body surface area \\[BSA\\], body mass index \\[BMI\\], weight, gender, race, and formulation).'}]}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Must give written informed consent and be willing to follow the protocol.\n2. Male or female participants, between 18 and 80 years of age, who have a diagnosis of moderately to severely active RA for at least 6 months as defined by at least six swollen joints (66 joint count) and at least eight tender joints (68 joint count) at Screening and Baseline (Day 1), and either an erythrocyte sedimentation rate (ESR) of \\> 28 mm/hour OR a C-reactive protein (CRP) level \\> 1.0 mg/dL (normal: \\< 0.4 mg/dL) at Screening. Patients must have had an inadequate response or intolerance to conventional DMARD therapy including at least one tumor necrosis factor (TNF) inhibitor.\n3. Positive for Radio Frequency and/or anti-CCP (Anti-cyclic citrullinated peptide) antibodies.\n4. Current treatment for RA on an outpatient basis:\n\n 1. Must be currently receiving and tolerating oral or parenteral MTX therapy at a dose of 15-25 mg per week (dose may be as low as 10 mg per week if the patient is unable to tolerate a higher dose) for at least 12 weeks immediately prior to Day 1. The dose should be stable for at least 4 weeks prior to Day 1 until Week 24. After Week 24 the administration route can be changed at the investigator's discretion.\n 2. Patients must be willing to receive oral folic acid (at least 5 mg/week or as per local practice) or equivalent during the entire study (mandatory co-medication for MTX treatment).\n 3. Biologic agents and DMARDs (other than MTX) must be withdrawn at least 2 weeks prior to Day 1, except azathioprine and etanercept which must be withdrawn at least 4 weeks prior to Day 1; abatacept, adalimumab, anakinra, certolizumab, infliximab, and golimumab at least 8 weeks prior to Day 1; tocilizumab at least 10 weeks prior to Day 1.\n 4. Leflunomide must be withdrawn at least 8 weeks prior to Day 1 or a minimum of 2 weeks prior to Day 1 if after 11 days of standard cholestyramine washout.\n 5. If receiving current treatment with oral corticosteroids (other than intra-articular or parenteral), the dose must not exceed 10 mg/day prednisolone or equivalent. During the 4 weeks prior to Baseline (Day 1) the dose must remain stable.\n 6. Intra-articular and parenteral corticosteroids are not permitted within 6 weeks prior to Baseline Day 1 or throughout the trial, with the exception of IV administration of 100 mg methylprednisolone 30 to 60 minutes prior to each infusion as this is part of the trial procedures.\n 7. Any concomitant non-steroidal anti-inflammatory drugs (NSAIDs) must be stable for at least 2 weeks prior to Day 1.\n 8. Patients may be taking oral hydroxychloroquine provided that the dose is not greater than 400 mg/day or chloroquine provided that the dose is not greater than 250 mg/day. These doses must have been stable for a minimum of 12 weeks prior to Day 1. The hydroxychloroquine or chloroquine treatment will need to be continued at a stable dose with the same formulation until the end of the trial.\n5. For participants of reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, intrauterine device, physical barrier) has to be used throughout trial participation. Females of child-bearing potential must also agree to use an acceptable method of contraception for 12 months following completion or discontinuation from the trial.\n\nExclusion criteria:\n\n1. ACR functional Class IV or wheelchair/bed bound.\n2. Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus infection.\n3. History of positive purified protein derivative test (positive tuberculosis \\[TB\\] test) without treatment for TB infection or chemoprophylaxis for TB exposure.\n4. Positive HIV or TB at screening.\n5. Known coronary artery disease or significant cardiac arrhythmias or severe congestive heart failure (New York Heart Association classes III or IV), or interstitial lung disease observed on chest X-ray.\n6. History of IgE-mediated (immunoglobulin E) or non-IgE-mediated hypersensitivity or known anaphylaxis to mouse proteins or a history of hypersensitivity to antibody therapy.\n7. History of cancer including solid tumors, hematologic malignancies, and carcinoma in situ (except participants with previous resected and cured basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ Grade I cervical cancer within 5 years prior to the Screening Visit).\n8. History of pancreatitis or current peptic ulcer disease.\n9. Receipt of a live/attenuated vaccine within 12 weeks prior to the Screening Visit.\n10. Any condition or treatment (including biologic therapies) that, in the opinion of the investigator, may place the patient at unacceptable risk during the trial.\n11. Pregnancy or breast feeding.\n12. History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, pulmonary fibrosis, or Feltys syndrome, scleroderma, inflammatory myopathy, mixed connective tissue disease, or any overlap syndrome).\n13. Diagnosis of juvenile idiopathic arthritis, also known as juvenile RA, and/or RA before age 16.\n14. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to the Screening Visit or planned within 24 weeks of the Screening Visit.\n15. Lack of peripheral venous access.\n16. Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders which, in the investigator's opinion, would preclude patient participation.\n17. Known concurrent viral hepatitis or known positivity to HBe-ag, HBV DNA, HBV DNA polymerase, HCVRNA, anti HCV antibodies.\n18. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of the Screening Visit or completion of oral anti-infectives within 2 weeks of the Screening Visit.\n19. History of deep space/tissue infection (e.g., fasciitis, abscess, osteomyelitis) within 52 weeks of the Screening Visit.\n20. History of serious infection or opportunistic infection in the last 2 years.\n21. Any neurological (congenital or acquired), vascular or systemic disorder that might affect any of the efficacy assessments, in particular, joint pain and swelling (e.g., Parkinson's disease, cerebral palsy, diabetic neuropathy).\n22. Currently active alcohol or drug abuse or history of alcohol or drug abuse (as determined by the investigator) within 52 weeks of the Screening Visit.\n23. Treatment with IV Gamma Globulin or the Prosorba® Column within 6 months of the Screening Visit.\n24. Treatment with IV or intramuscular corticosteroids.\n25. Previous treatment with a B cell modulating or cell depleting therapy.\n26. Intolerance or contraindications to IV glucocorticoids.\n27. AST (aspartate aminotransferase) or ALT (alanine aminotransferase)\\> 3 times ULN (Upper Limit of Normal)\n28. Hemoglobin \\< 8.0 g/dL.\n29. Levels of IgG \\< 5.0 g/L.\n30. Absolute neutrophil count \\< 1500/µL.\n31. Platelet count \\< 75000/µL.\n32. Participation in any previous clinical trial within 12 weeks of Screening."}, 'identificationModule': {'nctId': 'NCT01682512', 'briefTitle': 'Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Efficacy, Pharmacokinetics, and Safety of BI 695500 Versus Rituximab in Patients With Moderately to Severely Active Rheumatoid Arthritis: a Randomized, Double-blind, Parallel Arm, Multiple Dose, Active Comparator Trial.', 'orgStudyIdInfo': {'id': '1301.1'}, 'secondaryIdInfos': [{'id': '2011-002894-48', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part I BI 695500 group', 'description': 'BI 695500, Two infusions separated by 2 weeks, Intravenous infusion', 'interventionNames': ['Drug: BI 695500']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part I Rituxan®', 'description': 'rituximab, Two infusions separated by 2 weeks, Intravenous infusion', 'interventionNames': ['Drug: Rituxan®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part I MabThera®', 'description': 'rituximab, Two infusions separated by 2 weeks, Intravenous infusion', 'interventionNames': ['Drug: MabThera®']}, {'type': 'EXPERIMENTAL', 'label': 'Part II BI 695500 group', 'description': 'BI 695500, Two infusions separated by 2 weeks, Intravenous infusion', 'interventionNames': ['Drug: BI 695500']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part II rituximab group', 'description': 'rituximab, Two infusions separated by 2 weeks, Intravenous infusion', 'interventionNames': ['Drug: Rituxan®']}], 'interventions': [{'name': 'BI 695500', 'type': 'DRUG', 'armGroupLabels': ['Part II BI 695500 group']}, {'name': 'BI 695500', 'type': 'DRUG', 'armGroupLabels': ['Part I BI 695500 group']}, {'name': 'Rituxan®', 'type': 'DRUG', 'armGroupLabels': ['Part I Rituxan®']}, {'name': 'Rituxan®', 'type': 'DRUG', 'armGroupLabels': ['Part II rituximab group']}, {'name': 'MabThera®', 'type': 'DRUG', 'armGroupLabels': ['Part I MabThera®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Achieve Clinical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis &amp; 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