Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111449
First received: May 20, 2005
Last updated: May 13, 2013
Last verified: May 2013

May 20, 2005
May 13, 2013
June 2003
Not Provided
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
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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
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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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis
Drug: Etanercept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
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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
Not Provided
 
NCT00111449
20030117
Not Provided
Amgen
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
Amgen
May 2013

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