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Trial record 1 of 1 for:    NCT00111449
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Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111449
Recruitment Status : Completed
First Posted : May 23, 2005
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 20, 2005
First Posted Date  ICMJE May 23, 2005
Last Update Posted Date May 15, 2013
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2007)
Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Official Title  ICMJE A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Etanercept
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 20, 2007)
600
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00111449
Other Study ID Numbers  ICMJE 20030117
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date May 2013

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