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Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
This study has been completed.
Study NCT00111449   Information provided by Amgen
First Received: May 20, 2005   Last Updated: July 17, 2008   History of Changes

May 20, 2005
July 17, 2008
June 2003
 
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
*The measure of the effect of etanercept 50 mg bi-weekly compared to placebo in adult subjects with psoriasis.
Complete list of historical versions of study NCT00111449 on ClinicalTrials.gov Archive Site
  • Dermatology Live Quality Index (DLQI) response at week 12
  • Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
  • Psoriasis pain (VAS) at week 12
  • Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
  • PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
  • Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
  • Adverse events, infections injection site reactions during long-term therapy
  • Serious adverse events and infections during long-term therapy
  • Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
*Long term safety and tolerability of etanercept in adults with psoriasis.
 
Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Psoriasis
Drug: Etanercept
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
600
 
 

Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00111449
Global Development Leader, Amgen Inc.
20030117
Amgen
Wyeth
Study Director: MD Amgen
Amgen
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP