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

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NCT00063869

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Fibrosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00063869
Pfizer
Completed
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis

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[email protected]

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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis
A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pulmonary Fibrosis
Drug: Etanercept
Not Provided
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
March 2005
March 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00063869
0881A4-203
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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