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

This study is ongoing, but not recruiting participants.

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

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




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