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

This study has been completed.
Sponsor:
Collaborators:
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111436
First received: May 20, 2005
Last updated: April 24, 2013
Last verified: April 2013

May 20, 2005
April 24, 2013
April 2003
July 2005   (final data collection date for primary outcome measure)
  • Subject incidence of adverse events, including infectious episodes [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Changes from baseline in laboratory values [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00111436 on ClinicalTrials.gov Archive Site
  • Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Patient Global Assessment of psoriasis [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in SF-36 Health Survey scores [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Psoriasis
Drug: Etanercept
Enbrel 50 mg once weekly or 50 mg twice weekly
  • Experimental: 50 mg
    50 mg once weekly
    Intervention: Drug: Etanercept
  • Experimental: 100 mg
    50 mg twice weekly
    Intervention: Drug: Etanercept

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
912
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00111436
20030115
Not Provided
Amgen
Amgen
  • Immunex Corporation
  • Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: MD Amgen
Amgen
April 2013

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