Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00063869
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2003-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2003-07-07', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Idiopathic Pulmonary Fibrosis', 'Fibrosis, Pulmonary', 'Pulmonary Fibroses', 'Fibroses, Pulmonary'], 'conditions': ['Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '18669816', 'type': 'DERIVED', 'citation': 'Raghu G, Brown KK, Costabel U, Cottin V, du Bois RM, Lasky JA, Thomeer M, Utz JP, Khandker RK, McDermott L, Fatenejad S. Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebo-controlled trial. Am J Respir Crit Care Med. 2008 Nov 1;178(9):948-55. doi: 10.1164/rccm.200709-1446OC. Epub 2008 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IPF based on American Thoracic Society (ATS) guidelines\n\nExclusion Criteria:\n\n* Subjects with end-stage\n* Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor)\n* Receipt of any investigational drug or biological agent within 4 weeks of screening visit'}, 'identificationModule': {'nctId': 'NCT00063869', 'briefTitle': 'Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.', 'orgStudyIdInfo': {'id': '0881A4-203'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etanercept', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor, MD', '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'}}}}