A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.

Wyeth is now a wholly owned subsidiary of Pfizer0 sites88 target enrollmentJuly 9, 2003

ConditionsPulmonary Fibrosis

DrugsEtanercept

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary Fibrosis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 88
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 9, 2003

End Date

March 2005

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

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