An Evaluation of Etanercept in the Treatment of Subjects With Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00111111
First received: May 17, 2005
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

The purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.


Condition Intervention Phase
Psoriasis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Prospective Study to Evaluate the Effectiveness and Safety of Etanercept in the Treatment of Subjects With Psoriasis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Improvement in Physician's Global Assessment of Psoriasis

Secondary Outcome Measures:
  • Patient-reported outcomes including Dermatology Life Quality Index, SF-36, Euro-QoL 5D, and Beck Depression Index

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (BSA) at screening and baseline Exclusion Criteria: - Any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - Psoralen plus ultraviolet A radiation (PUVA), oral retinoids, cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - Ultraviolet light B (UVB) therapy, topical steroids, topical vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - Prior exposure to any tumor necrosis factor (TNF)-inhibitor, including etanercept - Severe comorbidities - Known history of tuberculosis (TB), or previous positive purified protein derivative (PPD) test

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00111111

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00111111     History of Changes
Other Study ID Numbers: 20030190
Study First Received: May 17, 2005
Last Updated: May 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014