Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT01543204
Status:
TERMINATED
Last Update Posted:
2017-12-29
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], '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'}]}}, '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': 'From first dose of study drug until 30 days after the last dose (up to 28 weeks).', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept 50mg BIW/50mg QW', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.', 'otherNumAtRisk': 64, 'otherNumAffected': 16, 'seriousNumAtRisk': 64, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '52.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '29.26', 'upperLimit': '61.51'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '15.39', 'upperLimit': '59.22'}]}]}], 'analyses': [{'pValue': '0.4505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.00', 'ciLowerLimit': '-15.97', 'ciUpperLimit': '35.97', 'statisticalMethod': 'Wald asymptotic test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '36.2'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '52.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '56.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '51.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '0.58', 'upperLimit': '16.16'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '23.82'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '7.54', 'upperLimit': '33.53'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '18.11', 'upperLimit': '61.56'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '22.46', 'upperLimit': '55.24'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '20.25', 'upperLimit': '66.50'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '44.7', 'groupId': 'OG000', 'lowerLimit': '28.62', 'upperLimit': '61.70'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '24.45', 'upperLimit': '71.14'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000', 'lowerLimit': '24.75', 'upperLimit': '57.90'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '17.30', 'upperLimit': '64.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '82.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '92.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '83.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '29.85', 'upperLimit': '61.33'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '43.03', 'upperLimit': '85.41'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '44.62', 'upperLimit': '76.64'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '69.62', 'upperLimit': '98.83'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '70.16', 'upperLimit': '94.29'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '75.13', 'upperLimit': '99.87'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '81.1', 'groupId': 'OG000', 'lowerLimit': '64.84', 'upperLimit': '92.04'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '48.80', 'upperLimit': '90.85'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000', 'lowerLimit': '65.67', 'upperLimit': '92.26'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '54.43', 'upperLimit': '93.95'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '61.79', 'upperLimit': '90.17'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '52.36', 'upperLimit': '93.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Static Physician Global Assessment (sPGA) at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.8', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '82.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '92.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '83.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '2.57', 'spread': '0.11', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}, {'value': '2.29', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '2.23', 'spread': '0.14', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '82.1'}, {'value': '1.71', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '0.14', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '92.1'}, {'value': '1.55', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.14', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '1.74', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.15', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '1.63', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '1.73', 'spread': '0.16', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '83.4'}, {'value': '1.83', 'spread': '0.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 50 Response at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '43.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '48.8', 'upperLimit': '73.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '87.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '88.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '10.30', 'upperLimit': '36.81'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '25.71', 'upperLimit': '70.22'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '42.10', 'upperLimit': '74.43'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '52.83', 'upperLimit': '91.78'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '56.11', 'upperLimit': '85.40'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '83.16', 'upperLimit': '100.00'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '78.4', 'groupId': 'OG000', 'lowerLimit': '61.79', 'upperLimit': '90.17'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '66.86', 'upperLimit': '98.70'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '68.75', 'upperLimit': '93.98'}, {'value': '89.5', 'groupId': 'OG001', 'lowerLimit': '66.86', 'upperLimit': '98.70'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '71.23', 'upperLimit': '95.46'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '65.29', 'upperLimit': '98.62'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 75 Response at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '37.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '33.4', 'upperLimit': '59.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '62.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '63.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '60.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '12.57'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '1.17', 'upperLimit': '30.38'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '9.30', 'upperLimit': '36.46'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '18.11', 'upperLimit': '61.56'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '31.51', 'upperLimit': '63.87'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '27.20', 'upperLimit': '72.80'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '51.4', 'groupId': 'OG000', 'lowerLimit': '34.40', 'upperLimit': '68.08'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '24.45', 'upperLimit': '71.14'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000', 'lowerLimit': '38.30', 'upperLimit': '71.38'}, {'value': '52.6', 'groupId': 'OG001', 'lowerLimit': '28.86', 'upperLimit': '75.55'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000', 'lowerLimit': '39.49', 'upperLimit': '72.90'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '17.30', 'upperLimit': '64.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 90 Response at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '34.5'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '37.9'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '30.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '36.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '8.41'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '16.11'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '17.32'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '16.11'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '14.60', 'upperLimit': '43.89'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '3.21', 'upperLimit': '37.89'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '27.0', 'groupId': 'OG000', 'lowerLimit': '13.79', 'upperLimit': '44.12'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '6.05', 'upperLimit': '45.57'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '11.44', 'upperLimit': '40.24'}, {'value': '15.8', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': '39.58'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '18.01', 'upperLimit': '49.79'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '34.71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000', 'lowerLimit': '52.0', 'upperLimit': '76.7'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '88.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '93.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '79.4', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '88.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '87.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '48.03', 'upperLimit': '78.45'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '43.03', 'upperLimit': '85.41'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '57.87', 'upperLimit': '86.96'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '69.62', 'upperLimit': '98.83'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '73.20', 'upperLimit': '95.81'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '75.13', 'upperLimit': '99.87'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '71.23', 'upperLimit': '95.46'}, {'value': '73.7', 'groupId': 'OG001', 'lowerLimit': '48.80', 'upperLimit': '90.85'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000', 'lowerLimit': '68.75', 'upperLimit': '93.98'}, {'value': '78.9', 'groupId': 'OG001', 'lowerLimit': '54.43', 'upperLimit': '93.95'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '67.99', 'upperLimit': '93.81'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '52.36', 'upperLimit': '93.59'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '19.6'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '44.7'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '40.9', 'upperLimit': '66.6'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000', 'lowerLimit': '36.4', 'upperLimit': '62.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '25.63'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '23.82'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '17.02', 'upperLimit': '47.57'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '18.11', 'upperLimit': '61.56'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '50.87', 'upperLimit': '81.43'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '15.39', 'upperLimit': '59.22'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '42.10', 'upperLimit': '75.25'}, {'value': '42.1', 'groupId': 'OG001', 'lowerLimit': '20.25', 'upperLimit': '66.50'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '43.39', 'upperLimit': '75.96'}, {'value': '47.4', 'groupId': 'OG001', 'lowerLimit': '24.45', 'upperLimit': '71.14'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '42.10', 'upperLimit': '75.25'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '17.30', 'upperLimit': '64.25'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '36.02', 'spread': '22.09', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '43.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '55.33', 'spread': '25.25', 'groupId': 'OG000', 'lowerLimit': '48.8', 'upperLimit': '73.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '67.97', 'spread': '24.20', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '87.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '67.98', 'spread': '29.83', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '88.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '69.58', 'spread': '26.16', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '67.25', 'spread': '30.41', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '33.38', 'spread': '3.32', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}, {'value': '42.29', 'spread': '4.98', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '55.90', 'spread': '3.93', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '82.1'}, {'value': '59.33', 'spread': '5.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '69.99', 'spread': '3.49', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '92.1'}, {'value': '73.71', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '70.76', 'spread': '3.60', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '67.31', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '73.47', 'spread': '3.75', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '72.79', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '73.34', 'spread': '3.57', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '83.4'}, {'value': '65.71', 'spread': '9.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '19.38', 'spread': '29.43', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '43.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '37.86', 'spread': '32.50', 'groupId': 'OG000', 'lowerLimit': '48.8', 'upperLimit': '73.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '53.82', 'spread': '32.66', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '87.3'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '60.36', 'spread': '29.48', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '88.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '60.33', 'spread': '29.79', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '58.13', 'spread': '34.40', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '89.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': "A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anti-adalimumab Antibody Positive', 'description': 'Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}, {'id': 'OG001', 'title': 'Anti-adalimumab Antibody Negative', 'description': 'Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.'}], 'classes': [{'title': 'Week 4 (n = 42, 21)', 'categories': [{'measurements': [{'value': '24.41', 'spread': '3.99', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '65.1'}, {'value': '15.32', 'spread': '7.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n = 39, 21)', 'categories': [{'measurements': [{'value': '40.34', 'spread': '5.32', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '82.1'}, {'value': '34.36', 'spread': '7.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n = 40, 20)', 'categories': [{'measurements': [{'value': '58.58', 'spread': '4.72', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '92.1'}, {'value': '50.91', 'spread': '8.00', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n = 37, 19)', 'categories': [{'measurements': [{'value': '61.21', 'spread': '4.83', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '63.14', 'spread': '5.19', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n = 38, 19)', 'categories': [{'measurements': [{'value': '65.56', 'spread': '4.75', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '86.0'}, {'value': '60.11', 'spread': '5.68', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n = 37, 18)', 'categories': [{'measurements': [{'value': '65.30', 'spread': '5.68', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '83.4'}, {'value': '52.72', 'spread': '6.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': "A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.", 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Treatment at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.3'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '13.1', 'spread': '0.8', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '24.2'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '21.3', 'spread': '0.9', 'groupId': 'OG000', 'lowerLimit': '11.9', 'upperLimit': '33.7'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '42.6'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '46.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Participants indicated their level of satisfaction with the medication\'s control of psoriasis on a scale from "very dissatisfied" to "very satisfied".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With Treatment at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '9.7', 'spread': '0.4', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '19.9'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '21.0', 'spread': '0.8', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '33.2'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '16.1', 'spread': '0.9', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '27.7'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '41.9'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '36.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Participants indicated their level of satisfaction with the medication\'s control of psoriasis on a scale from "very dissatisfied" to "very satisfied".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 12 (n = 60)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n = 61)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 12: Absenteeism (n = 43)', 'categories': [{'measurements': [{'value': '1.35', 'spread': '5.03', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Absenteeism (n = 43)', 'categories': [{'measurements': [{'value': '-1.62', 'spread': '15.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Presenteeism (n = 38)', 'categories': [{'measurements': [{'value': '14.47', 'spread': '24.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Presenteeism (n = 41)', 'categories': [{'measurements': [{'value': '11.22', 'spread': '19.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Work Productivity Loss (n = 43)', 'categories': [{'measurements': [{'value': '13.13', 'spread': '25.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Work Productivity Loss (n = 43)', 'categories': [{'measurements': [{'value': '8.93', 'spread': '21.68', 'groupId': 'OG000'}]}]}, {'title': 'Week 12: Activity Impairment (n = 60)', 'categories': [{'measurements': [{'value': '24.17', 'spread': '29.24', 'groupId': 'OG000'}]}]}, {'title': 'Week 24: Activity Impairment (n = 61)', 'categories': [{'measurements': [{'value': '17.87', 'spread': '26.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': "The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Assessment of Itch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 12 (n = 60)', 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n = 61)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 12 (n = 60)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n = 61)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Assessment of Flaking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Week 12 (n = 60)', 'categories': [{'measurements': [{'value': '4.2', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (n = 61)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'classes': [{'title': 'Any adverse event (AE)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AE leading to discontinuation from study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related adverse events (TRAE)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Serious treatment-related adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TRAE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'TRAE leading to discontinuation from study', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fatal treatment-related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug until 30 days after the last dose (up to 28 weeks)', 'description': 'A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Requirement for Alternative Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 48 centers in the United States (US) and Canada. Participants were enrolled from 01 February 2012 until 04 November 2014.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.0', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic/Latino', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psoriasis Area Severity Index (PASI)', 'classes': [{'categories': [{'measurements': [{'value': '16.81', 'spread': '6.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The psoriasis area and severity index (PASI) score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by physicians using a scale from 0 to 72, where 0 = no psoriasis and 72 = severe disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent of Body Surface Area (BSA) Involved in Psoriasis', 'classes': [{'categories': [{'measurements': [{'value': '20.90', 'spread': '16.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of BSA', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Static Physician Global Assessment (sPGA) of Psoriasis', 'classes': [{'title': '0 = Clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '1 = Almost clear', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '2 = Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '3 = Moderate', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': '4 = Severe', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '5 = Very severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "A physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 (very severe) with increasing severity.", 'unitOfMeasure': 'participants'}, {'title': 'Dermatology Life Quality Index (DLQI)', 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The DLQI is a skin disease-specific instrument to evaluate health related quality of life ranging from 0 (best possible score) to 30 (worst possible score). Data were available for 63 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Flaking', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of psoriasis flaking assessed by the participant on a scale between 0 and 10, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Data were available for 63 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Itch', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '2.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of a participant\'s itch assessed by the participant on a scale between 0 and 10, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Data were available for 63 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Pain', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '3.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The severity of the participant\'s psoriasis pain assessed by the participant on a scale between 0 and 10, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Data were available for 63 participants.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Assessment of Treatment Satisfaction', 'classes': [{'title': 'Very dissatisfied', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}, {'title': 'Dissatisfied', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Neither satisfied nor dissatisfied', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants indicated their level of satisfaction with the medication\'s control of psoriasis on a scale from "very dissatisfied" to "very satisfied". The response scale was adapted from the Medical Outcomes Study: Patient Satisfaction Survey.', 'unitOfMeasure': 'participants'}, {'title': 'Anti-adalimumab Antibody Status at Screening', 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Positive', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Business decision due to slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-05', 'studyFirstSubmitDate': '2012-01-17', 'resultsFirstSubmitDate': '2016-05-18', 'studyFirstSubmitQcDate': '2012-02-27', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-18', 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12', 'timeFrame': 'Week 12', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).'}, {'measure': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status', 'timeFrame': 'Week 12', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits', 'timeFrame': 'Weeks 4, 8, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).'}, {'measure': 'Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status', 'timeFrame': 'Weeks 4, 8, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).'}, {'measure': 'Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.'}, {'measure': 'Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.'}, {'measure': 'Static Physician Global Assessment (sPGA) at Each Visit', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).'}, {'measure': 'Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit', 'timeFrame': 'Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).'}, {'measure': 'Percentage of Participants With a PASI 50 Response at Each Visit', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With a PASI 75 Response at Each Visit', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With a PASI 90 Response at Each Visit', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.'}, {'measure': 'Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.'}, {'measure': 'Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.'}, {'measure': 'Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.'}, {'measure': 'Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.'}, {'measure': 'Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': 'The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.'}, {'measure': 'Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': 'The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement.'}, {'measure': 'Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis', 'timeFrame': 'Baseline and Weeks 4, 8, 12, 16, 20 and 24', 'description': "A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement."}, {'measure': 'Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status', 'timeFrame': 'Baseline and weeks 4, 8, 12, 16, 20 and 24', 'description': "A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value \\* 100, hence a positive value indicates improvement."}, {'measure': 'Patient Satisfaction With Treatment at Week 12', 'timeFrame': 'Week 12', 'description': 'Participants indicated their level of satisfaction with the medication\'s control of psoriasis on a scale from "very dissatisfied" to "very satisfied".'}, {'measure': 'Patient Satisfaction With Treatment at Week 24', 'timeFrame': 'Week 24', 'description': 'Participants indicated their level of satisfaction with the medication\'s control of psoriasis on a scale from "very dissatisfied" to "very satisfied".'}, {'measure': 'Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': 'The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.'}, {'measure': 'Change From Baseline in Work Productivity and Activity Impairment (WPAI)', 'timeFrame': 'Baseline and Weeks 12 and 24', 'description': "The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement."}, {'measure': 'Change From Baseline in Patient Assessment of Itch', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.'}, {'measure': 'Change From Baseline in Patient Assessment of Pain', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.'}, {'measure': 'Change From Baseline in Patient Assessment of Flaking', 'timeFrame': 'Baseline and Week 12 and 24', 'description': 'The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From first dose of study drug until 30 days after the last dose (up to 28 weeks)', 'description': 'A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['plaque psoriasis', 'etanercept', 'adalimumab'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '28196270', 'type': 'BACKGROUND', 'citation': 'Bagel J, Tyring S, Rice KC, Collier DH, Kricorian G, Chung J, Iles J, Stolshek BS, Kaliyaperumal A, Papp KA. Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab. Br J Dermatol. 2017 Aug;177(2):411-418. doi: 10.1111/bjd.15381. Epub 2017 Jul 19.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe plaque psoriasis\n* Loss of satisfactory response to adalimumab\n* Currently receiving or recently discontinued treatment with adalimumab\n\nExclusion Criteria:\n\n* Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis\n* Serious medical conditions'}, 'identificationModule': {'nctId': 'NCT01543204', 'briefTitle': 'Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab', 'orgStudyIdInfo': {'id': '20101145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etanercept 50 mg', 'description': 'Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.', 'interventionNames': ['Drug: Etanercept']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel®'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Etanercept 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': 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