Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-30 @ 8:27 AM
Study NCT ID:
NCT00333034
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2006-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-04', 'studyFirstSubmitDate': '2006-05-23', 'studyFirstSubmitQcDate': '2006-06-01', 'lastUpdatePostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.'}], 'secondaryOutcomes': [{'measure': 'The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,'}, {'measure': 'EQ5D, FACIT-F.'}]}, 'conditionsModule': {'keywords': ['Psoriasis'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'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.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.\\
'}, 'identificationModule': {'nctId': 'NCT00333034', 'briefTitle': 'Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': '0881A6-318'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etanercept', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '20354', 'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '80335', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '3501', 'city': 'Miskolc', 'country': 'Hungary', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '5400', 'city': 'Szolnok', 'country': 'Hungary', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '98158', 'city': 'Messina', 'country': 'Italy', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '9202 NN', 'city': 'Drachten', 'country': 'Netherlands', 'geoPoint': {'lat': 53.11254, 'lon': 6.0989}}, {'zip': '6525', 'city': 'Nijmegen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '50-368', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '11461', 'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28922', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '41003', 'city': 'Seville', 'country': 'Spain', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Austria, medinfo@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Belguim, trials-BEL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For France, infomedfrance@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Germany, medinfoDEU@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Hungary, WPBUMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Italy, descresg@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Netherlands, trials-NL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Poland, WPWZMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Romania, WVPIMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Spain, infomed@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}]}}}