Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

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NCT00111436

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

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


- Active guttate, erythrodermic, or pustular psoriasis at the time of the screening
visit


- Pregnant or breast-feeding females


- Evidence of skin conditions at the time of the screening visit (e.g., eczema) that
would interfere with evaluations of the effect of the investigational product on
psoriasis

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Official Title  ICMJE An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Brief Summary The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Etanercept
Enbrel 50 mg once weekly or 50 mg twice weekly
Study Arms  ICMJE
  • Experimental: 50 mg
    50 mg once weekly
    Intervention: Drug: Etanercept
  • Experimental: 100 mg
    50 mg twice weekly
    Intervention: Drug: Etanercept
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
Actual Enrollment  ICMJE
 (submitted: September 20, 2007)		912
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion Criteria:

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Pregnant or breast-feeding females
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the 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  
 
Administrative Information
NCT Number  ICMJE NCT00111436
Other Study ID Numbers  ICMJE 20030115
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
  • Immunex Corporation
  • Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date April 2013

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