Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT00332332
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2006-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'Up to 13 months', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.', 'otherNumAtRisk': 230, 'otherNumAffected': 59, 'seriousNumAtRisk': 230, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Thyroid gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 230, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With a Status of Mild or Better on Physician Global Assessment at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of participants', 'ciPctValue': '95', 'paramValue': '73.5', 'ciLowerLimit': '67.2', 'ciUpperLimit': '79.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest. Missing post-baseline values were imputed using last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 12 in Patient Global Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.9', 'groupId': 'OG000', 'lowerLimit': '-62.6', 'upperLimit': '-53.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-69.9', 'groupId': 'OG000', 'lowerLimit': '-75.1', 'upperLimit': '-64.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': 'Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.', 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-68.2', 'groupId': 'OG000', 'lowerLimit': '-73.7', 'upperLimit': '-62.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 12', 'description': "Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.", 'unitOfMeasure': 'Percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, composed of enrolled participants who received at least one dose of study medication and who had a baseline and at least one post-baseline measurement of the endpoint of interest, with imputation using Last Observation Carried Forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'Received Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Did not receive study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 17 March 2006 through 30 June 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '11.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '135', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '215', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Aborigine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Patient Global Assessment', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Patient global assessment of psoriasis scores range from 0 (good) to 5 (severe)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'spread': '21.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body surface area affected by psoriasis', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dermatology Quality of Life Index Total Score', 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '6.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This score ranges from 0 to 30, with 0 = no effect and 30 = large effect', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 246}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2006-05-30', 'resultsFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2006-05-30', 'lastUpdatePostDateStruct': {'date': '2014-07-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-03', 'studyFirstPostDateStruct': {'date': '2006-06-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With a Status of Mild or Better on Physician Global Assessment at Month 12', 'timeFrame': 'Month 12', 'description': 'The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Month 12 in Patient Global Assessment', 'timeFrame': 'Baseline and Month 12', 'description': 'Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.'}, {'measure': 'Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis', 'timeFrame': 'Baseline and Month 12', 'description': 'Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.'}, {'measure': 'Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score', 'timeFrame': 'Baseline and Month 12', 'description': "Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement."}]}, 'conditionsModule': {'keywords': ['Phase IV', 'Psoriasis', 'Inflammation'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '23582167', 'type': 'BACKGROUND', 'citation': 'Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population. J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38. doi: 10.2310/7750.2012.12036.'}, {'pmid': '23149196', 'type': 'BACKGROUND', 'citation': 'Vender R, Lynde C, Gilbert M, Ho V, Sapra S, Poulin-Costello M. Etanercept improves quality of life outcomes and treatment satisfaction in patients with moderate to severe plaque psoriasis in clinical practice. J Cutan Med Surg. 2012 Nov-Dec;16(6):407-16. doi: 10.1177/120347541201600609.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at baseline\n* Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)\n* Able to start Enbrel (Etanercept) therapy per the approved product monograph\n\nExclusion Criteria\n\n* Active infections at the initiation of Enbrel therapy.\n* Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.\n* Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.\n* Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.\n* Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.\n* Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.'}, 'identificationModule': {'nctId': 'NCT00332332', 'briefTitle': 'Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis', 'orgStudyIdInfo': {'id': '20050180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'etanercept', 'description': 'Open label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months.', 'interventionNames': ['Biological: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'BIOLOGICAL', 'otherNames': ['ENBREL'], 'description': 'etanercept subcutaneous injection', 'armGroupLabels': ['etanercept']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}