Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-02-01 @ 12:46 PM
Study NCT ID:
NCT01592292
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2012-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Month 12', 'description': 'The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.", 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.", 'otherNumAtRisk': 31, 'otherNumAffected': 2, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Anaphylactoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.35', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'categories': [{'measurements': [{'value': '-1.89', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3037', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.30', 'spread': '1.18', 'groupId': 'OG000'}, {'value': '5.47', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0951', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in DAS28 at Month 6 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 6', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.'}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in DAS28 at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=24, 17)', 'categories': [{'measurements': [{'value': '6.28', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=22, 16)', 'categories': [{'measurements': [{'value': '-2.30', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-2.29', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2390', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in DAS28 at Month 12 was performed using ANCOVA model with baseline DAS28 score and rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=34, 31)', 'categories': [{'measurements': [{'value': '13.38', 'spread': '7.22', 'groupId': 'OG000'}, {'value': '8.81', 'spread': '6.88', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=34, 31)', 'categories': [{'measurements': [{'value': '-8.21', 'spread': '7.54', 'groupId': 'OG000'}, {'value': '-6.32', 'spread': '7.06', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=29, 24)', 'categories': [{'measurements': [{'value': '-9.48', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '-5.96', 'spread': '6.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3212', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in TJC at Month 6 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7097', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).', 'unitOfMeasure': 'number of tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=31, 24)', 'categories': [{'measurements': [{'value': '12.87', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '7.79', 'spread': '5.99', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=31, 24)', 'categories': [{'measurements': [{'value': '-7.68', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '-5.79', 'spread': '6.17', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=26, 20)', 'categories': [{'measurements': [{'value': '-8.62', 'spread': '6.89', 'groupId': 'OG000'}, {'value': '-5.80', 'spread': '5.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2444', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in TJC at Month 6 was performed using ANCOVA with baseline TJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3903', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in TJC at Month 12 was performed using ANCOVA model with baseline TJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).', 'unitOfMeasure': 'number of tender joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=34, 31)', 'categories': [{'measurements': [{'value': '11.24', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '6.63', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=34, 31)', 'categories': [{'measurements': [{'value': '-7.00', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '-5.10', 'spread': '6.48', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n-29, 24)', 'categories': [{'measurements': [{'value': '-8.62', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '5.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5306', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2542', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).', 'unitOfMeasure': 'number of swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=31, 24)', 'categories': [{'measurements': [{'value': '11.16', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '7.13', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=31, 24)', 'categories': [{'measurements': [{'value': '-6.74', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '-5.21', 'spread': '6.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=26, 20)', 'categories': [{'measurements': [{'value': '-8.31', 'spread': '6.80', 'groupId': 'OG000'}, {'value': '-5.00', 'spread': '6.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2549', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in SJC at Month 6 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7644', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in SJC at Month 12 was performed using ANCOVA model with baseline SJC and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).', 'unitOfMeasure': 'number of swollen joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=34, 31)', 'categories': [{'measurements': [{'value': '67.00', 'spread': '27.50', 'groupId': 'OG000'}, {'value': '60.77', 'spread': '30.76', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=34, 31)', 'categories': [{'measurements': [{'value': '-19.35', 'spread': '27.03', 'groupId': 'OG000'}, {'value': '-15.55', 'spread': '33.19', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=31, 25)', 'categories': [{'measurements': [{'value': '-20.36', 'spread': '29.84', 'groupId': 'OG000'}, {'value': '-21.64', 'spread': '28.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8987', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5808', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.', 'unitOfMeasure': 'millimeter/hour (mm/hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=31, 24)', 'categories': [{'measurements': [{'value': '67.55', 'spread': '28.76', 'groupId': 'OG000'}, {'value': '61.58', 'spread': '29.47', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=31, 24)', 'categories': [{'measurements': [{'value': '-19.13', 'spread': '26.96', 'groupId': 'OG000'}, {'value': '-23.21', 'spread': '31.33', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=28, 20)', 'categories': [{'measurements': [{'value': '-21.54', 'spread': '30.51', 'groupId': 'OG000'}, {'value': '-22.10', 'spread': '26.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2282', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in ESR at Month 6 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5849', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in ESR at Month 12 was performed using ANCOVA model with baseline ESR and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=34, 31)', 'categories': [{'measurements': [{'value': '3.53', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=34, 30)', 'categories': [{'measurements': [{'value': '-1.84', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '3.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=31, 25)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '2.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4900', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1826', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.', 'unitOfMeasure': 'milligram/deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Baseline (n=31, 24)', 'categories': [{'measurements': [{'value': '3.53', 'spread': '3.17', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '2.78', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 6 (n=31, 24)', 'categories': [{'measurements': [{'value': '-1.79', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Change at Month 12 (n=28, 20)', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '2.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1894', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in CRP at Month 6 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1805', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in CRP at Month 12 was performed using ANCOVA model with baseline CRP and baseline rheumatoid factor status as covariate values.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point."}, {'type': 'SECONDARY', 'title': 'Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.69', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0568', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'categories': [{'measurements': [{'value': '0.73', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1167', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Change in HAQ-DI at Month 6 was performed using ANCOVA model with baseline rheumatoid factor status as covariate value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'OG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Adverse drug reactions (ADR)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'FG001', 'title': 'Other Anti-TNF Agent: Adalimumab', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'FG002', 'title': 'Other Anti-TNF Agent: Etanercept', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'FG003', 'title': 'Other Anti-TNF Agent: Infliximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician's discretion for RA treatment were observed for 12 months."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Intention to Treat (ITT) Set', 'achievements': [{'comment': 'Excluding primary effect evaluation omission.', 'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Standard Population Set (SPS)', 'achievements': [{'comment': 'Excluding participants with change of administration drug or suspension of drug administration.', 'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants who completed 12 months visit.', 'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Follow-up loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The arm Other anti-TNF agent consisting of participants treated with adalimumab, etanercept and infliximab was divided into individual treatment groups only for the purpose of Participant flow reporting. All other analyses were performed in Rituximab versus Other anti-TNF agent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'BG001', 'title': 'Other Anti-TNF Agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent to treat (ITT) set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2012-04-11', 'resultsFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-06', 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population', 'timeFrame': 'Baseline and Month 6', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)', 'timeFrame': 'Baseline and Month 6', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity."}], 'secondaryOutcomes': [{'measure': 'Efficacy: Mean Change From Baseline in DAS28 at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': "DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \\[mm/hr\\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\\<) 3.2 = low disease activity, a DAS28 score of \\>3.2 to 5.1 = moderate to high disease activity."}, {'measure': 'Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).'}, {'measure': 'Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).'}, {'measure': 'Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).'}, {'measure': 'Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).'}, {'measure': 'Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.'}, {'measure': 'Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.'}, {'measure': 'Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.'}, {'measure': 'Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)', 'timeFrame': 'Baseline, Month 6 and 12', 'description': 'CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.'}, {'measure': 'Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population', 'timeFrame': 'Month 6', 'description': 'The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.'}, {'measure': 'Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)', 'timeFrame': 'Month 6', 'description': 'The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.'}, {'measure': 'Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events', 'timeFrame': 'Baseline up to Month 12', 'description': 'An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult participants, \\>/=20 years of age\n* Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy\n\nExclusion Criteria:\n\n* Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis\n* Participants who have not signed the informed consent form'}, 'identificationModule': {'nctId': 'NCT01592292', 'briefTitle': 'An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent', 'orgStudyIdInfo': {'id': 'ML27923'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rituximab', 'description': "Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.", 'interventionNames': ['Drug: Rituximab']}, {'label': 'Other anti-TNF agent', 'description': "Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.", 'interventionNames': ['Drug: Adalimumab', 'Drug: Etanercept', 'Drug: Infliximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': "Rituximab as per physician's discretion.", 'armGroupLabels': ['Rituximab']}, {'name': 'Adalimumab', 'type': 'DRUG', 'description': "Adalimumab as per physician's discretion.", 'armGroupLabels': ['Other anti-TNF agent']}, {'name': 'Etanercept', 'type': 'DRUG', 'description': "Etanercept as per physician's discretion.", 'armGroupLabels': ['Other anti-TNF agent']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': "Infliximab as per physician's discretion.", 'armGroupLabels': ['Other anti-TNF agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48108', 'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42472', 'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '302-799', 'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '10380', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '63241', 'city': 'Jeju Special Self-Governing Province', 'country': 'South Korea'}, {'zip': '561-712', 'city': 'Jeollabuk-do', 'country': 'South Korea'}, {'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '134-722', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-713', 'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '442-723', 'city': 'Suwon', 'country': 'South Korea', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}