Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT00837434
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2009-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
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': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'DAITClinicalTrialsGov@niaid.nih.gov', 'phone': '301-594-7669', 'title': 'Director, Clinical Research Program', 'organization': 'DAIT/NIAID'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time of administration of the first dose of study drug until the participant completed study participation, an average of 24 weeks, or until 30 days after the participant prematurely withdrew.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.', 'otherNumAtRisk': 39, 'otherNumAffected': 31, 'seriousNumAtRisk': 39, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.', 'otherNumAtRisk': 19, 'otherNumAffected': 17, 'seriousNumAtRisk': 19, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of CD27+ Switched Memory B Cells at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Null Hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 does not differ between individuals treated with etanercept and those treated with adalimumab after adjusting for baseline CD27+ switched memory cells. Alt. hypothesis: Mean percentage of CD27+ switched memory cells in the peripheral blood at Week 12 in individuals treated with etanercept is lower than in those treated with adalimumab after adjusting for baseline CD27+ switched memory cells.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'P-value for testing treatment effect uses week 12 CD27+ switched memory as the outcome variable and adjusts for baseline CD27+ switched memory'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.', 'unitOfMeasure': 'Percentage of B Cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol population includes subjects with a baseline and week 12 (plus or minus 1 week) assessment that received at least 75% of the planned doses of either etanercept or adalimumab prior to week 12 and who did not have any serious protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Good responders: change in DAS28-CRP (Baseline-Week12) \\> 1.2 and Week 12 DAS-CRP score was \\<\\\\= 3.2. If the conditions for non-response\\* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. \\[\\*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline -Week 12) \\<0.6; 0.6 \\<\\\\= change in DAS28-CRP ( Baseline-Week 12) \\< 1.2 with Week 12 DAS28-CRP score \\> 5.1; a flare that required prednisone \\> 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to \\<\\\\= 10 mg/day by Week 8; or the participant required prednisone \\> 20 mg/day at any time point\\].', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Good responders had: change in DAS28-CRP (Baseline-Week 24) \\> 1.2 and the Week 24 DAS-CRP score was \\<= 3.2. If the conditions for non-response\\* or good response were not met then the DAS28-CRP response was considered moderate.\\[\\*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline -Week 24) \\<0.6; 0.6 \\<\\\\= change in DAS28-CRP ( Baseline-Week 24) \\< 1.2 with Week 24 DAS28-CRP score \\> 5.1 ; a flare that required prednisone \\> 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to \\<= 10 mg/day by Week 8; or the participant required prednisone \\> 20 mg/day at any time point\\]. Participants with measurements for designated time points were included in the analysis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting ACR20 Response Criteria at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '73.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting ACR20 Response Criteria at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting ACR50 Response Criteria at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for two participants who received Etanercept.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting ACR50 Response Criteria at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'OG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '63.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either etanercept or adalimumab. Data were not available for five participants who received Etanercept.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'FG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn by sponsor/regulatory agency', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Noncompliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Baseline assessments not done in time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to obtain study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were to be recruited from seven sites in the United States. Recruitment occurred at six sites. The first site was activated in April 2009. The first participant was randomized in July 2009 and the last participant was randomized in July 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.'}, {'id': 'BG001', 'title': 'Adalimumab', 'description': 'Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '52.0', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Detection of Either IgM-Rheumatoid Factor or Antibodies to Cyclic Citrullinated Peptide', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Serum IgM-Rheumatoid Factor (IgM RF) is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: \\>/=0.5 IU/mL. Negative value for RF: \\<0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage. Antibodies to Cyclic Citrullinated Peptide (anti-CCP) is often detected in in the blood of individuals with RA. Positive value for anti-CCP: \\>/=8 IU/mL. Negative value for anti-CCP: \\<8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.', 'unitOfMeasure': 'participants'}, {'title': 'Detection of IgM-Rheumatoid Factor (IgM RF)', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Serum IgM RF is an antibody often present in the blood of a person with rheumatoid arthritis. Positive value for RF: \\>/=0.5 IU/mL. Negative value for RF: \\<0.5 IU/mL. Presence of IgM RF indicates aggressive rheumatoid arthritis (RA) and higher risk of joint damage.', 'unitOfMeasure': 'participants'}, {'title': 'Detection of Antibodies to Cyclic Citrullinated Antibody Peptide', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Anti-CCP is often present in the blood of individuals with RA. Positive value for anti-CCP: \\>/=8 IU/mL. Negative value for anti-CCP: \\<8 IU/mL. High anti-CCP indicates an aggressive RA and a higher risk of joint damage.', 'unitOfMeasure': 'participants'}, {'title': 'Methotrexate Dosage', 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '18.8', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participants were required to be on a stable dose of methotrexate to be enrolled in the study. Stable dose definition: between 7.5 mg and 25 mg by mouth or subcutaneously weekly for at least 8 weeks prior to randomization.', 'unitOfMeasure': 'mg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years with Rheumatoid Arthritis', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '7.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years since diagnosis of rheumatoid arthritis by a physician. Participants were required to be diagnosed with Rheumatoid Arthritis at least 3 months before enrolling in the study.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) Score', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living activities (using 20 questions). Each question is scored 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do). In addition, category scores are modified if an aid or device is used, for example, a walker, or help is received from another person in the daily living activities. Scores from each of the 8 categories are totaled and can range from 0 to 24.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'C-reactive Protein (CRP) Level', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '25.5', 'groupId': 'BG000'}, {'value': '13.3', 'spread': '24.3', 'groupId': 'BG001'}, {'value': '13.8', 'spread': '24.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'CRP is an acute phase reactant that is used to identify the presence of nonspecific inflammation. The CRP normal reference range depends on the laboratory. In this study the upper limit of normal ranged from 4 to 10.9 mg/L. An increased CRP level indicated the presence of inflammation. A low CRP may mean an absence of inflammation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Tender Joint Count', 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '12.3', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Tender Joint Count (TJC) is calculated based on tenderness response of 28 joints examined. TJC possible values range from 0 to 28. A lower TJC indicates less joint tenderness.', 'unitOfMeasure': 'Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Swollen Joint Count at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '9.7', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Swollen Joint Count (SJC) is calculated based on swelling response of 28 joints examined. SJC possible values range from 0 to 28. A lower SJC indicates less joint swelling.', 'unitOfMeasure': 'Joints', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Patient's Global Assessment of Disease Activity- Visual Analog Scale (PtGADA-VAS)", 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '7.3', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '6.4', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'A self-reported measure of perceived disease activity obtained by responding to the question "considering all the ways that your arthritis affects you, rate how you are doing on the following scale by placing a vertical mark." A vertical mark on a 10 cm line rated 0 (very well) to 10 (very bad) determines the score. The range: 0 to 10, with 10 being severe symptoms).', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Activity Score Using C-reactive Protein (DAS28-CRP)', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '5.3', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The DAS28 is: a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (\\>5.1=high disease activity; \\<=3.2=low disease activity; \\<2.6=remission); a continuous variable which is a composite of 4 variables(the number of tender joints out of 28, the number of swollen joints out of 28 joints, serum C-reactive protein (CRP) in mg/L and subject assessment of disease activity measure on a visual analogue scale (VAS) of 100 mm).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either etanercept or adalimumab.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'dispFirstSubmitDate': '2015-01-30', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2009-02-03', 'dispFirstSubmitQcDate': '2015-01-30', 'resultsFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2009-02-03', 'dispFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-04-10', 'studyFirstPostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of CD27+ Switched Memory B Cells at Week 12', 'timeFrame': 'Week 12', 'description': 'Analysis of the steady state composition of the B cell compartment were performed using ex-vivo multicolor flow cytometry on Ficoll isolated peripheral blood mononuclear cells (PBMCs). CD27+ switched memory B cells are a subset of B cells and are assessed by flow cytometry. CD27+ switched memory B cells are expressed as a percent of B cells. Lower CD27+ memory B cells indicate a decrease in the generation of B cell memory which may be caused by blocking lymphotoxin (LT) and tumor necrosis factor (TNF) signaling.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 12', 'timeFrame': 'Week 12', 'description': 'Good responders: change in DAS28-CRP (Baseline-Week12) \\> 1.2 and Week 12 DAS-CRP score was \\<\\\\= 3.2. If the conditions for non-response\\* or good response were not met, the DAS28-CRP response was considered moderate. Participants with measurements for designated time points were included in the analysis. \\[\\*Non-responders had any of 4 conditions: change in DAS28-CRP (Baseline -Week 12) \\<0.6; 0.6 \\<\\\\= change in DAS28-CRP ( Baseline-Week 12) \\< 1.2 with Week 12 DAS28-CRP score \\> 5.1; a flare that required prednisone \\> 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to \\<\\\\= 10 mg/day by Week 8; or the participant required prednisone \\> 20 mg/day at any time point\\].'}, {'measure': 'Percentage of Participants Fulfilling DAS-28-CRP "Good or Moderate Response" Criteria at Week 24', 'timeFrame': 'Week 24', 'description': 'Good responders had: change in DAS28-CRP (Baseline-Week 24) \\> 1.2 and the Week 24 DAS-CRP score was \\<= 3.2. If the conditions for non-response\\* or good response were not met then the DAS28-CRP response was considered moderate.\\[\\*Non-responders had any of the 4 conditions: change in DAS28-CRP (Baseline -Week 24) \\<0.6; 0.6 \\<\\\\= change in DAS28-CRP ( Baseline-Week 24) \\< 1.2 with Week 24 DAS28-CRP score \\> 5.1 ; a flare that required prednisone \\> 10 mg/day (or equivalent) beyond Week 8 or the inability to taper prednisone to \\<= 10 mg/day by Week 8; or the participant required prednisone \\> 20 mg/day at any time point\\]. Participants with measurements for designated time points were included in the analysis.'}, {'measure': 'Percentage of Participants Meeting ACR20 Response Criteria at Week 12', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis."}, {'measure': 'Percentage of Participants Meeting ACR20 Response Criteria at Week 24', 'timeFrame': 'Week 24', 'description': "The American College of Rheumatology (ACR) 20 Responder Index is defined as someone who achieved at least 20% improvement in the tender and swollen 28-joint count, and 20% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis."}, {'measure': 'Percentage of Participants Meeting ACR50 Response Criteria at Week 12', 'timeFrame': 'Week 12', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis."}, {'measure': 'Percentage of Participants Meeting ACR50 Response Criteria at Week 24', 'timeFrame': 'Week 24', 'description': "The American College of Rheumatology (ACR) 50 Responder Index is defined as someone who achieved at least 50% improvement in the tender and swollen 28-joint count, and 50% improvement in at least three of the following 5 measures:\n\n* Patient's pain assessment (Visual Analogue Scale (VAS) 100 mm)\n* Patient's global assessment of disease activity (VAS 100 mm)\n* Physician's global assessment of disease activity (VAS 100 mm)\n* Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)\n* Acute phase reactant (CRP).\n\nParticipants with measurements for designated time points were included in the analysis."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tumor necrosis factor (TNF) blockade', 'inflammatory autoimmune disorder'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'availIpds': [{'id': 'SDY824', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY824', 'type': 'Individual Participant Data Set', 'comment': 'The Immunology Database and Analysis Portal (ImmPort) is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts. The portal includes available analysis tools for researchers.'}, {'id': 'SDY824', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY824', 'type': 'Study Protocol', 'comment': 'ImmPort study identifier is SDY824.'}, {'id': 'SDY824', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY824', 'type': 'Study summary, -design, -adverse event(s), -summary of participant assessments, -medications, -demographics, -lab tests, -mechanistic assays, -study files et al.', 'comment': 'ImmPort study identifier is SDY824.'}], 'references': [{'pmid': '18937634', 'type': 'BACKGROUND', 'citation': 'Bingham CO 3rd. Emerging therapeutics for rheumatoid arthritis. Bull NYU Hosp Jt Dis. 2008;66(3):210-5.'}, {'pmid': '19149036', 'type': 'BACKGROUND', 'citation': 'Otomo K, Koike T. [TNF inhibitors for treatment of rheumatoid arthritis]. Nihon Naika Gakkai Zasshi. 2008 Oct 10;97(10):2405-12. doi: 10.2169/naika.97.2405. No abstract available. Japanese.'}, {'pmid': '18677056', 'type': 'BACKGROUND', 'citation': 'Soen S. [Daily practice using the guidelines for prevention and treatment of osteoporosis. The effects of anti-TNF therapy on bone and joint manifestations in rheumatoid arthritis]. Clin Calcium. 2008 Aug;18(8):1169-75. Japanese.'}, {'pmid': '34347945', 'type': 'RESULT', 'citation': 'Meednu N, Barnard J, Callahan K, Coca A, Marston B, Thiele R, Tabechian D, Bolster M, Curtis J, Mackay M, Graf J, Keating R, Smith E, Boyle K, Keyes-Elstein L, Welch B, Goldmuntz E, Anolik JH. Activated Peripheral Blood B Cells in Rheumatoid Arthritis and Their Relationship to Anti-Tumor Necrosis Factor Treatment and Response: A Randomized Clinical Trial of the Effects of Anti-Tumor Necrosis Factor on B Cells. Arthritis Rheumatol. 2022 Feb;74(2):200-211. doi: 10.1002/art.41941. Epub 2021 Dec 27.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT)'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is a chronic disease that leads to inflammation and progressive joint damage. RA is a systemic inflammatory autoimmune disorder affecting almost 1% of the United States population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. The primary purpose of this study is to determine the effectiveness of two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.\n\nAdditionally, there are 4 optional sub-studies as part of the trial:\n\n* B-Cell Kinetic Sub-Study to look at changes in B-cell subsets over time and how quickly reductions in B-cell memory occur\n* Vaccine Response Sub-Study to assess B cell memory in response to immunization with hepatitis B,-hepatitis A, and diphtheria/tetanus vaccines, and to determine whether T-cell vaccine responses are altered with TNF blockade\n* Tonsil Biopsy Sub-Study to evaluate how TNF blockade affects memory B-cells in the tonsil dendritic cells and germinal cells\n* Synovial Biopsy Sub-Study to evaluate how TNF blockade affects changes in memory B-cells in lymphoid tissue.', 'detailedDescription': 'RA is characterized by persistent inflammation of peripheral joints, causing pain, stiffness, swelling and warmth. Over the past 10 years, advancements in biotechnology have revolutionized RA therapeutics with biologically-derived immunomodulating compounds. TNF-alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness two TNF inhibitors, etanercept and adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with RA.\n\nThis study will last 24 weeks. Participants will be randomized into one of two treatment groups. Participants in one group will receive a dose of etanercept once every week for 24 weeks. Participants in the other group will receive a dose of adalimumab once every 2 weeks for 24 weeks.\n\nThis study consists of seven study visits after randomization and will occur at study entry and Weeks 4, 8, 12, 16, 20 and 24. Blood collection will occur at all study visits. A written participant assessment, vital signs, and physical exam will occur at study entry and Weeks 12 and 24. Follow-up calls to assess safety are scheduled for Weeks 4, 8, 16, and 20.\n\nAdditionally, participants will be offered the opportunity to enter one of four sub-studies as mentioned in the brief summary above: B Cell Kinetic Sub-Study, Vaccine Response Sub-Study, Tonsil Biopsy Sub-Study, and Synovial Biopsy Sub-Study. More information on these sub-studies is in the protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RA\\*\n* Disease duration as defined from the onset of symptoms of at least 3 months prior to study entry\n* Active RA with DAS28 \\> 4.4, clinically requiring the addition of anti-TNF therapy\n* Stable dose of MTX between 7.5 mg and 25 mg weekly for at least 8 weeks prior to study entry\n* Able and willing to self-administer subcutaneous injections or have available qualified person(s) or caregiver to administer subcutaneous injections\n* For females, agree to use accepted methods of contraception during the duration of the study and for 150 days after study completion\\*. \\*More information on these criterion can be found in the protocol.\n\nExclusion Criteria:\n\n* Positive PPD test - a tuberculosis (TB) skin test: (\\> 5 mm induration regardless of prior Bacille Calmette-Guerin \\[BCG\\] vaccine administration) without evidence of ongoing treatment for at least 30 days or completed treatment\n* History of positive PPD or chest x-ray findings indicative of prior TB infection, without documentation of either treatment for TB infection or chemoprophylaxis for TB exposure\n* Prednisone dose \\> 10 mg/day (or equivalent dose of another corticosteroid) within 30 days prior to study entry\n* Definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment\\*\n* Concomitant use of DMARDSs (e.g., disease-modifying antirheumatic drugs)\\*\n* Any immunosuppressive therapy other than MTX, NSAIDs, or corticosteroids\\*\n* Current or previous use of any biologic agent\n* Presence of open leg ulcers\n* Chronic or persistent infection that might be worsened by immunosuppressive treatment\\*\n* Active infection or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to study entry\n* Received oral antibiotics, antivirals, or antifungals within 14 days prior to study entry\n* Certain abnormal laboratory values\\*\n* Any medical condition that, in the opinion of the investigator, would interfere with the study\n* History of malignancy other than treated localized carcinoma in situ of the cervix or adequately treated non-metastatic squamous or basal cell skin carcinoma within 10 years prior to study entry\n* Any Investigational agent within the earlier of 4 weeks or 5 half-lives prior to study entry\n* History of drug or alcohol abuse within 6 months prior to study entry\n* Known allergy or hypersensitivity to study products\n* Inability or unwillingness to follow the protocol\n* Any condition or treatment that, in the opinion of the investigator, places the participant at an unacceptable risk\n* Pregnant or breastfeeding \\*More information on these criterion are in the protocol.'}, 'identificationModule': {'nctId': 'NCT00837434', 'briefTitle': 'Anti-TNF Agents for the Treatment of Rheumatoid Arthritis', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'DAIT ARA06'}, 'secondaryIdInfos': [{'id': 'NIAID CRMS ID#: 20001', 'type': 'OTHER', 'domain': 'DAIT NIAID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etanercept', 'description': 'Participants receive a subcutaneous injection of etanercept once every week for 24 weeks', 'interventionNames': ['Drug: Etanercept']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab', 'description': 'Participants receive a subcutaneous injection of adalimumab once every 2 weeks for 24 weeks', 'interventionNames': ['Drug: Adalimumab']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel®'], 'description': '50 mg dose of etanercept by subcutaneous injection', 'armGroupLabels': ['Etanercept']}, {'name': 'Adalimumab', 'type': 'DRUG', 'otherNames': ['Humira®)'], 'description': '40 mg dose of adalimumab by subcutaneous injection', 'armGroupLabels': ['Adalimumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Feinstein Institute for Medical Research', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Jennifer A. Anolik, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'Inaki Sanz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'R. John Looney, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'Meggan Mackay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Feinstein Institute for Medical Research NS-LIJ Health System'}, {'name': 'Jeffrey Curtis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'url': 'https://www.immport.org/home', 'timeFrame': 'On average, within 24 months after database lock for the trial.', 'ipdSharing': 'YES', 'description': 'The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.', 'accessCriteria': 'Open access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Autoimmunity Centers of Excellence', 'class': 'OTHER'}, {'name': 'Rho Federal Systems Division, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}