Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-03-13 @ 1:28 PM
Study NCT ID:
NCT01927757
Status:
TERMINATED
Last Update Posted:
2018-01-30
First Post:
2013-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'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': 'D008727', 'term': 'Methotrexate'}], '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': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '34 weeks', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.', 'otherNumAtRisk': 88, 'otherNumAffected': 38, 'seriousNumAtRisk': 88, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '46.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Presence of Anti-adalimumab Antibodies', 'description': 'Participants with anti-adalimumab antibodies.'}, {'id': 'OG001', 'title': 'Absence of Anti-adalimumab Antibodies', 'description': 'Participants with absence of anti-adalimumab antibodies.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '70.9'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '46.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Primary Failure', 'description': 'Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.'}, {'id': 'OG001', 'title': 'Secondary Failure', 'description': 'Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '45.5'}, {'value': '41.2', 'groupId': 'OG001', 'lowerLimit': '27.6', 'upperLimit': '55.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an ACR 20 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '45.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an ACR 50 Response at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '19.4'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '25.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an ACR 70 Response at Weeks 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '8.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '10.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with non-missing data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:\n\n* The number of swollen and tender joints assessed using the 28-joint count;\n* C-reactive protein (CRP) level\n* Patient's global assessment of disease activity assessed on a score from 0 to 100.\n\nThe DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward imputation (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '41.7', 'spread': '1.15', 'groupId': 'OG000', 'lowerLimit': '31.1', 'upperLimit': '52.2'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '48.8', 'spread': '1.26', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '59.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward imputation (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With DAS 28-CRP < 3.2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '13.1', 'spread': '1.15', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '20.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '22.6', 'spread': '1.26', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '31.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward imputation (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.269', 'spread': '0.540', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.307', 'spread': '0.602', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': 'The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, last observation carried forward imputation (LOCF) was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '4.46', 'spread': '6.34', 'groupId': 'OG000'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '3.34', 'spread': '7.20', 'groupId': 'OG000'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '4.27', 'spread': '9.41', 'groupId': 'OG000'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '2.86', 'spread': '8.97', 'groupId': 'OG000'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '3.48', 'spread': '9.31', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '3.06', 'spread': '10.94', 'groupId': 'OG000'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '4.20', 'spread': '9.80', 'groupId': 'OG000'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '3.38', 'spread': '9.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '5.03', 'spread': '7.66', 'groupId': 'OG000'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '4.19', 'spread': '7.68', 'groupId': 'OG000'}]}]}, {'title': 'Bodily Pain', 'categories': [{'measurements': [{'value': '6.36', 'spread': '9.72', 'groupId': 'OG000'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '2.62', 'spread': '8.64', 'groupId': 'OG000'}]}]}, {'title': 'Vitality', 'categories': [{'measurements': [{'value': '4.65', 'spread': '9.55', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '2.90', 'spread': '10.42', 'groupId': 'OG000'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '4.49', 'spread': '10.34', 'groupId': 'OG000'}]}]}, {'title': 'Mental Health', 'categories': [{'measurements': [{'value': '3.66', 'spread': '9.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment (WPAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'classes': [{'title': 'Baseline: Percent Work Time Missed (n = 40)', 'categories': [{'measurements': [{'value': '15.31', 'spread': '27.76', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Percent Impairment While Working (n= 37)', 'categories': [{'measurements': [{'value': '41.62', 'spread': '24.44', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Percent Overall Work Impairment (n = 37)', 'categories': [{'measurements': [{'value': '45.33', 'spread': '26.36', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Percent Activity Impairment (n = 85)', 'categories': [{'measurements': [{'value': '57.88', 'spread': '21.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Percent Work Time Missed (n = 38)', 'categories': [{'measurements': [{'value': '9.49', 'spread': '24.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Percent Impairment While Working (n = 36)', 'categories': [{'measurements': [{'value': '29.17', 'spread': '23.59', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Percent Overall Work Impairment (n = 36)', 'categories': [{'measurements': [{'value': '31.92', 'spread': '25.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Percent Activity Impairment (n = 82)', 'categories': [{'measurements': [{'value': '43.17', 'spread': '24.99', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Percent Work Time Missed (n = 41)', 'categories': [{'measurements': [{'value': '5.50', 'spread': '17.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Percent Impairment While Working (n = 40)', 'categories': [{'measurements': [{'value': '25.75', 'spread': '23.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Percent Overall Work Impairment (n = 40)', 'categories': [{'measurements': [{'value': '27.88', 'spread': '24.79', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Percent Activity Impairment (n = 83)', 'categories': [{'measurements': [{'value': '40.00', 'spread': '26.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 12 and week 24', 'description': "This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. "n" indicates the number of participants included in each analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}]}, {'type': 'Received Etanercept', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ethical Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'This study was conducted at 30 centers in the United States and Canada. Participants were enrolled from 06 May 2013 to 02 December 2014.\n\nPatients with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost satisfactory response to adalimumab when used as the first biologic agent in combination with methotrexate were eligible.', 'preAssignmentDetails': 'A total of 90 participants were enrolled in the study, however, 4 participants from 1 site were excluded from all efficacy analyses due to good clinical practice (GCP) violations. Three of these participants who received etanercept are included in safety results.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '11.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Black (or African American)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Anti-adalimumab Antibody Status', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Adalimumab Response Failure Type', 'classes': [{'title': 'Primary', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Secondary', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Primary failure: Failure to achieve an American College of Rheumatology 20% improvement (ACR20) or equivalent as judged by the investigator; Secondary failure: Loss of an ACR20 response or equivalent as judged by the investigator.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full analysis set, which included all participants enrolled who received at least 1 dose of etanercept. Three additional participants were excluded from the FAS due to GCP violations.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'Business decision due to slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2015-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2013-06-05', 'resultsFirstSubmitDate': '2016-05-30', 'studyFirstSubmitQcDate': '2013-08-20', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-30', 'studyFirstPostDateStruct': {'date': '2013-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}, {'measure': 'Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup', 'timeFrame': 'Baseline and Week 12', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}, {'measure': 'Percentage of Participants With an ACR 20 Response at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}, {'measure': 'Percentage of Participants With an ACR 50 Response at Weeks 12 and 24', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}, {'measure': 'Percentage of Participants With an ACR 70 Response at Weeks 12 and 24', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.'}, {'measure': 'Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:\n\n* The number of swollen and tender joints assessed using the 28-joint count;\n* C-reactive protein (CRP) level\n* Patient's global assessment of disease activity assessed on a score from 0 to 100.\n\nThe DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement."}, {'measure': 'Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity."}, {'measure': 'Percentage of Participants With DAS 28-CRP < 3.2', 'timeFrame': 'Weeks 12 and 24', 'description': "The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)', 'timeFrame': 'Baseline and weeks 12 and 24', 'description': 'The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).'}, {'measure': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.'}, {'measure': 'Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.'}, {'measure': 'Work Productivity and Activity Impairment (WPAI)', 'timeFrame': 'Baseline, week 12 and week 24', 'description': "This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'etanercept', 'arthritis', 'adalimumab failure to respond', 'loss of response to adalimumab', 'ACR20', 'methotrexate', 'Swollen joints', 'tender joints'], 'conditions': ['Moderate to Severe Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28900875', 'type': 'BACKGROUND', 'citation': 'Bessette L, Khraishi M, Kivitz AJ, Kaliyaperumal A, Grantab R, Poulin-Costello M, Isaila M, Collier D. Single-Arm Study of Etanercept in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment. Rheumatol Ther. 2017 Dec;4(2):391-404. doi: 10.1007/s40744-017-0079-x. Epub 2017 Sep 12.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide informed consent\n* Diagnosed with moderate to severe rheumatoid arthritis for at least 6 months\n* Active RA with at least 3 swollen and tender joints\n* Failure to respond to a combination treatment of adalimumab and methotrexate (must have taken combination at least 3 months) or loss of a satisfactory response to the combination of adalimumab and methotrexate, which was taken for at least 6 months (if currently taking adalimumab must complete 2 weeks without it prior to starting study drug)\n* Negative for hepatitis B and C\n* Negative serum and urine pregnancy tests before starting study\n* currently taking (stable dose) 15 mg methotrexate weekly for at least 8 weeks/has been taking methotrexate for at least 12 weeks total - lower dose of 10 mg per week is permitted with documented intolerability\n* Normal chest X-ray within 3 months\n* Negative testing for tuberculosis (TB)\n\nExclusion Criteria:\n\n* Class IV RA (wheel-chair or bed-bound)\n* Significant concurrent medical conditions, including: (uncontrolled type 1 diabetes, poorly controlled type 2 diabetes, symptomatic heart failure, myocardial infarction in past year, history of unstable angina within past year, uncontrolled hypertension, severe chronic pulmonary disease, major chronic inflammatory or connective tissue disease other than RA, Multiple sclerosis, active malignancy, or history of cancer, alcoholic hepatitis or history of alcoholic liver disease)\n* Other inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01927757', 'acronym': 'ROCkIES', 'briefTitle': 'Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Single Arm Trial to Evaluate the Efficacy of Etanercept in Moderate to Severe Rheumatoid Arthritis Patients Who Failed to Respond or Lost a Satisfactory Response to Treatment With Adalimumab When Used as Their First Biologic Agent', 'orgStudyIdInfo': {'id': '20120125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etanercept', 'description': 'Participants received etanercept 50 mg administered subcutaneously once a week with methotrexate for 24 weeks', 'interventionNames': ['Biological: Etanercept', 'Drug: Methotrexate']}], 'interventions': [{'name': 'Etanercept', 'type': 'BIOLOGICAL', 'otherNames': ['Enbrel®'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Etanercept']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Background methotrexate at least 15 mg weekly', 'armGroupLabels': ['Etanercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92543', 'city': 'Hemet', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92395', 'city': 'Victorville', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.53611, 'lon': -117.29116}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '34698', 'city': 'Dunedin', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 28.0199, 'lon': -82.77323}}, {'zip': '33774', 'city': 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