Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis

Phase 2

Completed

• Conditions: Pulmonary Fibrosis

• Registration Number: NCT00063869
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-07-07
• Study First Submitted QC: 2003-07-08
• Study First Posted: 2003-07-09
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-03
• Last Update Posted: 2009-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Diagnosis of IPF based on American Thoracic Society (ATS) guidelines

Exclusion Criteria

• Subjects with end-stage
• Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor)
• Receipt of any investigational drug or biological agent within 4 weeks of screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL