Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT00546533
Status:
COMPLETED
Last Update Posted:
2007-10-19
First Post:
2007-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy and Safety of Etanercept
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2005-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-18', 'studyFirstSubmitDate': '2007-10-18', 'studyFirstSubmitQcDate': '2007-10-18', 'lastUpdatePostDateStruct': {'date': '2007-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).\n* Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy).\n* Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.\n\nExclusion Criteria:\n\n* Uncooperative patients with a history of poor compliance.\n* Known hypersensitivity to etanercept or any of its components.\n* Known significant concurrent medical disease'}, 'identificationModule': {'nctId': 'NCT00546533', 'briefTitle': 'Study Evaluating the Efficacy and Safety of Etanercept', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)', 'orgStudyIdInfo': {'id': '0881A-101101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etanercept', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}