Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 8:03 AM
Study NCT ID:
NCT00252668
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
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'}, {'id': 'D008727', 'term': 'Methotrexate'}], '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'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2005-11-09', 'studyFirstSubmitQcDate': '2005-11-09', 'lastUpdatePostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.'}]}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who completed the previous double-blind,randomized study.\n* Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.\n\nExclusion Criteria:\n\n* Dose of prednisone\\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation.\n* Clinically relevant concurrent medical events including: uncompensated congestive heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.'}, 'identificationModule': {'nctId': 'NCT00252668', 'briefTitle': 'Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects', 'orgStudyIdInfo': {'id': '0881A1-101631'}, 'secondaryIdInfos': [{'id': 'B1801221'}, {'id': '0881A1-400'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Etanercept', 'type': 'DRUG'}, {'name': 'Methotrexate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'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 Germany, MedinfoDEU@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Sweden, Denmark and Norway, MedInfoNord@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Belgium, trials-BEL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Greece, decresg@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Czech Republic, WPPGCLI@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Romania, WPVIMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Poland, WPWZMED@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}