Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis - Full Text View

Purpose

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).

Condition	Intervention	Phase
Pulmonary Fibrosis	Drug: Etanercept	Phase II

MedlinePlus related topics:

Pulmonary Fibrosis

Drug Information available for:

Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Double-Blind, Parallel, Placebo-Controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063869

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor, MD	Wyeth

More Information

Publications indexed to this study:

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. Epub 2008 Jul 31.

Study ID Numbers:	0881A4-203
First Received:	July 7, 2003
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00063869
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Idiopathic Pulmonary Fibrosis

Fibrosis, Pulmonary

Pulmonary Fibroses

Fibroses, Pulmonary

Study placed in the following topic categories:

Lung Diseases, Interstitial

Respiratory Tract Diseases

Fibrosis

Hamman-Rich syndrome

Lung Diseases

Fibrosing alveolitis

TNFR-Fc fusion protein

Pulmonary Fibrosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Physiological Effects of Drugs

Gastrointestinal Agents

Immunosuppressive Agents

Pharmacologic Actions

Pathologic Processes

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00063869