Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 5:35 AM
Study NCT ID:
NCT00245960
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2005-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'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': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept BIW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.', 'otherNumAffected': 213, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Etanercept QW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.', 'otherNumAffected': 190, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Digestive general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic and nutritional general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and appendages general disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 41}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Local reaction to procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 379, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 373, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept BIW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}, {'id': 'OG001', 'title': 'Etanercept QW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}], 'classes': [{'title': 'At 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '284', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}]}]}, {'title': 'At 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '303', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24 weeks', 'description': "The PsARC response was defined as improvement in at least 2 of the four criteria: \\>=30% decrease in swollen joint count, \\>=30% decrease in tender joint count, \\>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \\>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.'}, {'type': 'PRIMARY', 'title': 'Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept BIW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}, {'id': 'OG001', 'title': 'Etanercept QW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population was the Modified Intent to Treat (mITT) population which includes all randomized patients who received ≥ 1 dose of study drug and had at least 1 post baseline efficacy evaluation. Last observation carried forward (LOCF) approach used for missing data imputation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept BIW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}, {'id': 'FG001', 'title': 'Etanercept QW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}], 'periods': [{'title': 'Period 1 (Double Blind): 1-12 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '379'}, {'groupId': 'FG001', 'numSubjects': '373'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Period 2 (Open Label): 13-24 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '362'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '350'}, {'groupId': 'FG001', 'numSubjects': '344'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Unsatisfactory Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited worldwide from December 2005 to September 2007.', 'preAssignmentDetails': 'Subjects were screened up to 4 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'BG000'}, {'value': '373', 'groupId': 'BG001'}, {'value': '752', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept BIW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}, {'id': 'BG001', 'title': 'Etanercept QW/QW', 'description': 'Period 1 (Double blind): etanercept 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): etanercept 50mg weekly (QW) for weeks 13-24.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.11', 'spread': '11.39', 'groupId': 'BG000'}, {'value': '46.93', 'spread': '11.41', 'groupId': 'BG001'}, {'value': '46.52', 'spread': '11.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '473', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 752}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2008-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-29', 'studyFirstSubmitDate': '2005-10-26', 'resultsFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2005-10-27', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-31', 'studyFirstPostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis', 'timeFrame': '12 weeks', 'description': 'The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)', 'timeFrame': '12 and 24 weeks', 'description': "The PsARC response was defined as improvement in at least 2 of the four criteria: \\>=30% decrease in swollen joint count, \\>=30% decrease in tender joint count, \\>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \\>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriatic Arthritis', 'Skin Disease', 'Joint Disease'], 'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '30323006', 'type': 'DERIVED', 'citation': 'Coates LC, Gottlieb AB, Merola JF, Boone C, Szumski A, Chhabra A. Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value. J Rheumatol. 2019 Feb;46(2):160-165. doi: 10.3899/jrheum.180249. Epub 2018 Oct 15.'}, {'pmid': '25913550', 'type': 'DERIVED', 'citation': 'Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.'}, {'pmid': '25535650', 'type': 'DERIVED', 'citation': 'Kirkham B, de Vlam K, Li W, Boggs R, Mallbris L, Nab HW, Tarallo M. Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial. Clin Exp Rheumatol. 2015 Jan-Feb;33(1):11-9. Epub 2014 Dec 22.'}, {'pmid': '24861696', 'type': 'DERIVED', 'citation': 'Griffiths CE, Sterry W, Brock F, Dilleen M, Stefanidis D, Germain JM, Mallbris L. Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept. Br J Dermatol. 2015 Jan;172(1):230-8. doi: 10.1111/bjd.13139. Epub 2014 Nov 13.'}, {'pmid': '22035157', 'type': 'DERIVED', 'citation': 'Gniadecki R, Robertson D, Molta CT, Freundlich B, Pedersen R, Li W, Boggs R, Zbrozek AS. Self-reported health outcomes in patients with psoriasis and psoriatic arthritis randomized to two etanercept regimens. J Eur Acad Dermatol Venereol. 2012 Nov;26(11):1436-43. doi: 10.1111/j.1468-3083.2011.04308.x. Epub 2011 Oct 31.'}, {'pmid': '20124563', 'type': 'DERIVED', 'citation': 'Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. 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